Primary Outcomes

Description: PVR = 80* (PAP - PCWP) / CO (dyn·sec·cm-5) PAP = pulmonary arterial pressure PCWP = pulmonary capillary wedge pressure CO = cardiac output

Measure: Peak percent reduction in PVR (Pulmonary vascular resistance) from "baseline 2" for untreated patients

Time: Up to 5 hours post inhalation of BAY1237592 compared to "baseline 2"

---

Description: PVR = 80* (PAP - PCWP) / CO (dyn·sec·cm-5)

Measure: Peak percent reduction in PVR from "baseline" for pre-treated patients

Time: Up to 5 hours post inhalation of BAY1237592 compared to "baseline"

---

Secondary Outcomes

Measure: Incidence of treatment-emergent adverse events (TEAEs)

Time: Up to 30 days after treatment

---

Primary Outcomes

Description: Changes in systolic blood pressure between baseline and 12 months will be compared between the intervention group and control group.

Measure: Change in Systolic Blood Pressure between baseline and 12 months

Time: Baseline, 12 months

---

Secondary Outcomes

Description: Changes in diastolic blood pressure between baseline and 12 months will be compared between the intervention group and control group.

Measure: Change in Diastolic Blood Pressure between baseline and 12 months

Time: Baseline, 12 months

---

Description: BP will be collected at 4 time points - baseline, 1, 6, 12 months. This will be compared between the intervention group and control group.

Measure: Slope of systolic BP between baseline and 12 months using all available BP values

Time: Baseline up to 12 months

---

Description: BP will be collected at 4 time points - baseline, 1, 6, 12 months. This will be compared between the intervention group and control group.

Measure: Slope of diastolic BP between baseline and 12 months using all available BP values

Time: Baseline up to 12 months

---

Description: This is a 28-item questionnaire measuring objective CKD disease knowledge and includes questions about goals, cardiovascular risk, and anti-hypertensive medications. Patients will answer the questions with a yes or no answer and their score will be based on how many responses were correct. This number will be converted to a percentage.

Measure: CKD knowledge measured by the Kidney Knowledge Survey (KiKS)

Time: Baseline up to 12 months

---

Description: This is a 13-item measure with the answers on a Likert scale of 1 (not at all sure) to 4 (extremely sure). The higher the score the higher the self-efficacy, with a range from 13-52.

Measure: Medication Adherence Self-Efficacy Scale-Revised (MASES-R)

Time: Baseline up to 12 months

---

Description: This scale is to quantify adherence to pharmacological treatments by means of 8 items. Patients will answer yes or no to these items, where a no response = 1 point and a yes response = 0 points. Levels of adherence are based on the following scores: 3-8 = low adherence; 1-2 = medium adherence; 0 = high adherence.

Measure: Morisky Medication Adherence Scale (MMAS - 8)

Time: Baseline up to 12 months

---

Description: Length of time provider spends with the patient. This will be compared between the intervention group and control group.

Measure: Visit Time with provider

Time: Enrollment visit (baseline)

---

Description: Length of time between patient check-in and check-out. This will be compared between the intervention group and control group.

Measure: Total time in clinic

Time: Enrollment visit (baseline)

---

Description: This contains a 17-item questionnaire in which the participants select scores from 1-7 or does not apply. A number of 1 = not at all and a score of 7 = considered very true, and zero = not applicable.

Measure: Patient Motivation by the Treatment Self-Regulation Questionnaire scale (TSRQ)

Time: Baseline up to 12 months

---

Description: This is a 15-item questionnaire that assesses the quality of physician to patient communication completed by the patients. There are 5 answers to choose from; poor, fair, good, very good, and excellent. The Score range is 1-5, where 1 means negative perception of communication and 5 means positive perception of communication.

Measure: Satisfaction with CKD care based on Communication Assessment Tool (CAT)

Time: Baseline up to 12 months

---

Description: This is a 21-item questionnaire that is completed by the patients, and select from the the 4 choices: very strongly agree, strongly agree, agree, and neutral/disagree. Each answer is worth one point on a Likert scale with a higher score meaning more satisfied.

Measure: Satisfaction with CKD care based on Consultation Care Measure (CCM)

Time: Baseline up to 12 months

---

Description: During health coach phone calls, participants will be asked 37 questions about their perceptions of the health coach program, including how much their participation in CHECK-D helped participants change various behaviors. Participant responses will be used to examine various measures of reliability and validity during the analyses of data acquired though this survey.

Measure: Perceptions of health coaching for the intervention group

Time: Baseline up to 12 months

---

Description: The EMR will be reviewed to evaluate the patients medication refills for adherence.

Measure: Medication adherence from the electronic medical record (EMR)

Time: Baseline up to 12 months

---

Description: This is an 8-item scale regarding self-efficacy where each statement is rated on the level of agreement from 1-5. 1 is disagree and 5 is agree.

Measure: Self-efficacy for disease self-management based on The Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)

Time: Baseline up to 12 months

---

Description: This is a 5-item survey about knowledge and behaviors regarding sodium in the diet.

Measure: Self-reported Blood Pressure-Related Behaviors Survey

Time: Baseline up to 12 months

---

Description: Provider adoption will be measured by the percentage of enrolled patients whose providers used the EDI with them during their visit. Data will be collected by EMR query and a 1-item question in the patient survey.

Measure: Provider Adoption based on EMR query and patient survey

Time: Baseline

---

Description: Provider fidelity will be measured by the percentage of enrolled patients in the intervention clinics whose providers entered 1-2 patient specific goals in the EDI. This will be collected through EMR query.

Measure: Provider Fidelity measured by EMR query

Time: Baseline

---

Description: Provider perception of usefulness will be measured by a survey of 2-3 questions about how useful they thought it was.

Measure: Provider Perception of Usefulness by provider survey

Time: Baseline up to 12 months

---

Description: Change in Serum Creatinine between baseline and 12-months

Measure: Change in serum creatinine

Time: Baseline, 12 months

---

Measure: Change in urine protein-creatinine ratio

Time: Baseline, 12 months

---

Measure: Change in estimated glomerular filtration rate (eGFR)

Time: Baseline, 12 months

---

Primary Outcomes

Description: The percentage of patients admitted to the ICU at any time during the 28 days of onset COVID-19.

Measure: Occupancy rate in the intensive care unit (ICU)

Time: up to 28 days

---

Description: The number of patients requiring mechanical ventilation.

Measure: Mechanical Ventilation

Time: up to 28 days

---

Description: The number of patients who died of 2019-nCoV infection.

Measure: Death

Time: up to 28 days

---

Secondary Outcomes

Description: The number of died 2019-nCoV infected patients from any cause.

Measure: All cause mortality

Time: up to 28 days

---

Description: Time from onset of symptoms to admitted to the ICU, requiring mechanical ventilation, and death.

Measure: Time from onset of symptoms to main outcome and its components

Time: up to 28 days

---

Description: Time to Clinical Recovery

Measure: Time to Clinical Recovery

Time: up to 28 days

---

Primary Outcomes

Measure: Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

---

Measure: Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

---

Measure: Elimination rate constant (ke) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

---

Measure: Half-life (t1/2) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

---

Measure: Absorption rate constant (ka) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

---

Measure: AUC (area under the curve) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

---

Measure: Maximum concentration (Cmax) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

---

Measure: Time to achieve maximum concentration (Tmax) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

---

Primary Outcomes

Description: mortality in 28-day

Measure: Rate of Death

Time: From date of admission until the date of death from any cause, up to 60 days

---

Secondary Outcomes

Description: evaluate the severity of pneumonia according to CT scans and clinical manifestation

Measure: the severity of pneumonia

Time: From date of admission until the date of discharge or death from any cause, up to 60 days

---

Other Outcomes

Description: days from admission to discharge or death

Measure: the length of hospital stay

Time: From date of admission until the date of discharge or death from any cause, up to 60 days

---

Primary Outcomes

Description: Time from randomization to the first occurrence of any of the clinical events above

Measure: Number of Covid-19 positive participants who die, require intubation in ICU, or require hospitalization for non-invasive ventilation (NIV)

Time: 12 months

---

Secondary Outcomes

Description: Time from randomization to the first occurrence of above

Measure: Number of Covid-19 positive participants who die

Time: 12 months

---

Description: Time from randomization to the first occurrence of above

Measure: Number of Covid-19 positive participants who require intubation in intensive care unit (ICU)

Time: 12 months

---

Description: Time from randomization to the first occurrence of above

Measure: Number of Covid-19 positive participants who require hospitalization for non-invasive ventilation (NIV)

Time: 12 months

---

Description: Time from randomization to the first occurrence of above

Measure: Number of SARS-CoV-2 positive participants

Time: 12 months

---

Measure: Maximum troponin T value (ng/L) among Covid-19 positive participants who require acute hospitalization

Time: 12 months

---

Description: Performed in a random sub-sample of the cohort (both study arms)

Measure: 24 hour mean systolic BP (mmHg) on ambulatory BP monitoring

Time: 12 months

---

Description: Time from randomization to the first occurrence of above

Measure: All-cause mortality

Time: 12 months

---

Primary Outcomes

Description: Using anamnestic data collected from the health record of the hospital or of the general practitioner, we will count the number of COVID-19 patients enrolled that were treated with ACE Inhibitors or ARB.

Measure: Numbers of COVID-19 patients enrolled that use ACE inhibitors and/or Angiotensin Receptor Blockers (ARB) as antihypertensive agents

Time: 3 months

---

Description: This study want to observe whether the assumption of antihypertensive ACE inhibitors or ARB increases the severity of the clinical manifestation of COVID19

Measure: Numbers of COVID-19 patients enrolled with no symptoms, with moderate symptoms or with severe symptoms of pneumoni based on the WHO specification for ARDS that also used ACE inhibitors and/or Angiotensin Receptor Blockers (ARB) as antihypertensive agents

Time: 3 months

---

Secondary Outcomes

Description: Collecting selected data from the health record and hospital charts of the patients we will assess whether among the recorded parameters there are any that can predict COVID19 prevalence and severity

Measure: Number and type of anthropometric and clinical parameters that associate with COVID19 and COVID-19 severity

Time: 3 months

---

Primary Outcomes

Description: BP one week before COVID-19 infection and 3 weeks follow-up after COVID-19 onset

Measure: BP (hypertensive efficacy)

Time: 4 weeks

---

Secondary Outcomes

Description: features of disease course: number of patients and duration of fever (above 37.2C), duration of cough (days), duration of throat pain (days), headache (days), nausea or vomiting (days), diarrhea (days), myalgia or arthalgia (days), and numder of patients who need hospital and intensive care unit

Measure: COVID-19 course

Time: 3 weeks

---

Primary Outcomes

Description: Death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke

Measure: Adverse events

Time: through study completion, an average of 2 weeks

---

Secondary Outcomes

Description: Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke analyzed separately for each of the endpoints

Measure: Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke

Time: through study completion, an average of 2 weeks

---

Description: Ventilation during hospitalization

Measure: Ventilation during hospitalization

Time: through study completion, an average of 2 weeks

---

Description: Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke analyzed separately for each of the endpoints

Measure: Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke

Time: prolonged follow up, through study completion, an average of one year

---

Primary Outcomes

Description: Prevalence of a previous treatment by angiotensin converting enzyme inhibitors in patients with and without confirmed Covid-19 pneumonia.

Measure: Prior treatment by ACEi

Time: at admission to hospital

---

Description: Prevalence of a previous treatment by angiotensin II type 1-receptor blockers in patients with and without confirmed Covid-19 pneumonia.

Measure: Prior treatment by ARB

Time: at admission to hospital

---

Secondary Outcomes

Description: Association between COVID-19 infection status and other baseline characteristics and comorbidities (age, sex, history of hypertension, chronic heart disease, diabetes mellitus, COPD, asthma, obesity, allergies)

Measure: Baseline characteristics and comorbidities

Time: at admission to hospital

---

Description: Association between previous treatment by ACEi and ARBs and clinical course of COVID-19 (one-month mortality, hospitalization in intensive care unit, duration of hospital stay, early discharge to home)

Measure: Major Clinical Adverse Events

Time: One month follow-up

---

Primary Outcomes

Description: Ambulatory Blood Pressure Monitoring systolic blood pressure

Measure: ABPM systolic blood pressure

Time: 24 hours (all day and night)

---

Secondary Outcomes

Description: Ambulatory Blood Pressure Monitoring diastolic blood pressure

Measure: 24-hr ABPM DBP

Time: 24 hours (all day and night)

---

Description: Day Ambulatory Blood Pressure Monitoring systolic blood pressure

Measure: day ABPM SBP

Time: 8am to 8pm

---

Description: Day Ambulatory Blood Pressure Monitoring diastolic blood pressure

Measure: day ABPM DBP

Time: 8am to 8pm

---

Description: Night Ambulatory Blood Pressure Monitoring systolic blood pressure

Measure: night ABPM SBP

Time: 8pm to 8am

---

Description: Night Ambulatory Blood Pressure Monitoring diastolic blood pressure

Measure: night ABPM DBP

Time: 8pm to 8am

---

Description: The fall in pressure, called the "dip", is defined as the difference between daytime mean systolic pressure and nighttime mean systolic pressure expressed as a percentage of the day value

Measure: dipping status

Time: 24 hours (all day and night)

---

Description: he morning surge was defined as the difference between the mean systolic blood pressure during the 2 hours after waking and arising minus the mean systolic blood pressure during the hour that included the lowest blood pressure during sleep.

Measure: morning surge

Time: 24 hours (all day and night)

---

Description: 24 hour Ambulatory Blood Pressure Monitoring heart rate

Measure: 24 hour ABPM HR

Time: 24hr (all day and night)

---

Description: Day Ambulatory Blood Pressure Monitoring heart rate

Measure: day ABPM HR

Time: 8 am to 8 pm

---

Description: Night Ambulatory Blood Pressure Monitoring heart rate

Measure: night ABPM HR

Time: 8pm to 8 am

---

Primary Outcomes

Description: We will measure systolic blood pressure before and 6 months after the interventions

Measure: Systolic blood pressure

Time: Six months

---

Secondary Outcomes

Description: We will measure participants' weight in kilograms before and six months after the intervention

Measure: Mean weight change for intervention and control groups

Time: Six months

---

Description: Changes in dietary behavior will be monitored by using the Dietary Approaches to Stop Hypertension Accordance Score. Score ranges from 0 to 9. A low score represents a poor diet for hypertension control. The higher the score the more appropriate for hypertension control.

Measure: Level of adherence to the Dietary Approaches to Stop Hypertension (DASH) Diet

Time: Six months

---

Description: Using the results of the Global Physical Activity Questionnaire median physical activity in MET-minutes per week will be calculated before the intervention as well as six months post intervention

Measure: Assessing physical activity levels using the Global Physical Activity Questionnaire (GPAQ)

Time: Six months

---

Description: Perceived self-efficacy scores will be calculated using a tool developed by K Lorig(Stanford University School of Medicine) for measuring self-efficacy in chronic disease management programs. Score ranges from 1 to 10. A higher score is better.

Measure: Self-Efficacy for Managing Chronic Diseases 6-item Scale

Time: Six months

---

Primary Outcomes

Description: To determine the prevalence of pulmonary hypertension and right ventricular load in patients with COVID-19 treated in intensive care unit evaluated by routine echocardiography.

Measure: Prevalence

Time: Day 1

---

Primary Outcomes

Description: For outpatient Veterans with a positive SARS-CoV-2 test (Aims 1.1 and 1.2), the primary outcome is a composite of time to all-cause hospitalization or all-cause mortality.

Measure: All-Cause-Hospitalization or All-Cause Mortality

Time: Through study completion (approximately July 31, 2020).

---

Description: For Veterans hospitalized with COVID-19 (Aims 2.1 and 2.2), the primary outcome is time to all-cause mortality.

Measure: All-Cause Mortality

Time: Through study completion (approximately July 31, 2020).

---

Secondary Outcomes

Description: For aims 1 and 2, a secondary outcome will be time to intensive care unit (ICU) admission.

Measure: ICU admission

Time: Through study completion (approximately July 31, 2020).

---

Description: For aims 1 and 2, a secondary outcome will be duration of hospitalization.

Measure: Duration of hospitalization

Time: Through study completion (approximately July 31, 2020).

---

Description: For aim 2, a secondary outcome will be time to mechanical ventilation.

Measure: Mechanical ventilation

Time: Through study completion (approximately July 31, 2020).

---

Description: For aim 2, a secondary outcome will be time to in-hospital dialysis.

Measure: Dialysis

Time: Through study completion (approximately July 31, 2020).

---

Other Outcomes

Description: Time to gastrointestinal bleed. This will be a negative control outcome.

Measure: Gastrointestinal bleed

Time: Through study completion (approximately July 31, 2020).

---

Description: Time to urinary tract infection. This will be a negative control outcome.

Measure: Urinary tract infection

Time: Through study completion (approximately July 31, 2020).

---

Primary Outcomes

Description: Left atrium volume index

Measure: • LA volume index

Time: 3 minutes

---

Description: Left ventricle telediastolic diameter

Measure: • LV telediastolic diameter

Time: 3 minutes

---

Description: Left ventricle telesystolic diameter

Measure: • LV telesystolic diameter

Time: 3 minutes

---

Description: Left ventricle posterior wall

Measure: • LV posterior wall

Time: 3 minutes

---

Description: Right atrium area

Measure: • RA area

Time: 3 minutes

---

Description: Right ventricle basal dimensión

Measure: • RV basal dimensión

Time: 3 minutes

---

Description: Right ventricle cavity dimensión

Measure: • RV mid cavity dimension;

Time: 3 minutes

---

Description: Right ventricle longitudinal dimension

Measure: • RV longitudinal dimension

Time: 3 minutes

---

Description: Distal, right ventricle outflow tract dimension at the distal or pulmonic valve level

Measure: • Distal, RV outflow tract dimension at the distal or pulmonic valve level

Time: 3 minutes

---

Description: Proximal right ventricle outflow tract dimension at the proximal subvalvular level

Measure: • Proximal RV outflow tract dimension at the proximal subvalvular level

Time: 3 minutes

---

Description: • Tricuspid annular plane systolic excursion

Measure: • TAPSE

Time: 3 minutes

---

Description: Right ventricle free Wall strain

Measure: • RV free Wall strain

Time: 3 minutes

---

Description: Inferior cava vein PW Doppler

Measure: • Inferior cava vein PW Doppler

Time: 3 minutes

---

Description: E wave mitral

Measure: • E wave mitral

Time: 3 minutes

---

Description: A wave mitral

Measure: • A wave mitral

Time: 3 minutes

---

Description: E wave /A wave mitral

Measure: • E wave /A wave mitral

Time: 3 minutes

---

Description: E-wave at mitral annulus

Measure: • E-wave at mitral annulus

Time: 3 minutes

---

Description: E-wave at mitral annulus / A-wave at the mitral annulus

Measure: • E-wave at mitral annulus / A-wave at the mitral annulus

Time: 3 minutes

---

Description: E wave/ E-wave at the mitral annulus

Measure: • E wave/ E-wave at the mitral annulus

Time: 3 minutes

---

Description: E tricuspid (E)

Measure: • E tricuspid (E)

Time: 3 minutes

---

Description: A triuspid (A)

Measure: • A tricuspid (A)

Time: 3 minutes

---

Description: E/A

Measure: • E/A

Time: 3 minutes

---

Description: Systolic pulmonary artery pressure

Measure: • Systolic pulmonary artery pressure

Time: 3 minutes

---

Description: E-wave at the tricuspid annulus

Measure: • E-wave at the tricuspid annulus

Time: 3 minutes

---

Description: Mean pulmonary artery pressure

Measure: • Mean pulmonary artery pressure

Time: 3 minutes

---

Description: Stroke volume

Measure: • Stroke volume

Time: 3 minutes

---

Description: Cardiac output

Measure: • Cardiac output

Time: 3 minutes

---

Primary Outcomes

Description: Fraction of oxygen-saturated hemoglobin relative to the patient's total blood hemoglobin, represented as a percentage. Measurement using the pulse oximeter of the multi-parameter vital signs monitor. Measurement units % SpO2.

Measure: Oxygen saturation

Time: 1 minute

---

Description: Balance between the production of heat by the body and its loss. Measurement using an infrared thermometer. Units of measure degrees centigrade.

Measure: Body temperature

Time: 30 seconds

---

Description: Force exerted by the blood against the walls of the vessels (arteries) as it is pumped by the heart. Measurement using the multi-parameter vital signs monitor. Units of measurement in mmHg. Obtain systolic and diastolic pressure.

Measure: Blood pressure

Time: 2 minutes

---

Description: Number of times the heart beats for a certain period of time, measured by the multi-parameter vital signs monitor. Units of measure beats per minute.

Measure: Heart rate

Time: 1 minute

---

Description: Number of breaths that a living being takes during a certain period of time, Count daily with the patient at rest the number of breaths for one minute each time the chest rises. Measured in breaths per minute.

Measure: Breathing frequency

Time: 1 minute

---

Description: Disruption of the organic functions of any living being. The existence of the death certificate will be reviewed daily. Categories: dead or alive.

Measure: Death

Time: 10 seconds

---

Description: Simultaneous knowledge, in the unity of time, of oneself (subject) and of the surrounding world (object), is the reflection of reality. It will be evaluated daily with the glasgow scale. Categories: 1.13-15 points. 2. 9-12 points. 3. 3-8 points.

Measure: Awareness

Time: 2 minutes

---

Description: Number of days that the patient remains hospitalized. It is reviewed daily if the patient has been discharged. Categories: 1.Hopitalized. 2. Released.

Measure: Hospital stay

Time: 10 seconds

---

Description: Rapid sequential evaluation of organic failures. Evaluate daily the qSOFA items and get your score. Measure in points.

Measure: qSOFA score

Time: 1 minute

---

Description: Clinically and study-based acquired need to open the airway in order to supply him with oxygen. Check daily if a cannula or tube was placed in the windpipe. Categories: 1.Progress to ventilation. 2. Does not progress to ventilation.

Measure: Progression to ventilation

Time: 10 seconds

---

Description: Need for a multidisciplinary team, for presenting an acute critical state, with the support of technological resources for monitoring, diagnosis and treatment. It is reviewed daily if the patient is directed to ICU. Categories: 1.Enter ICU. 2. You do not enter ICU.

Measure: Progression to Intensive Care Unit

Time: 10 seconds

---

Description: Any localized painful discomfort in the head. Evaluate and ask for pain by numbering it from 1-10, where 0 is the absence and 10 is the greatest intensity (Daily, 2 shifts, 21 days).

Measure: Cephalea

Time: 10 seconds

---

Description: Physical actions that you can take without pain or discomfort. Evaluate what movements and activities he tolerates (Daily, 2 shifts, 21 days). Categories: 1.Walk. 2.He can stand 3.Sit. 4.Postrate.

Measure: Activity level

Time: 10 seconds

---

Description: Body postures that are used to facilitate the examination of the patient, his treatment, the prevention of injuries due to immobility, and his comfort when he is bedridden. Observe the anatomical position in which he is found (Daily, 2 shifts, 21 days). Categories: 1. In the prone position. 2.In the supine position. 3.Fowler. 4.Semifowler. 5.Other

Measure: Anatomic position

Time: 10 seconds

---

Description: Evaluate the level of hydration of the hair (Daily, morning, 21 days). Categories: 1.Hydrated, shiny. 2.Opaque. 3.Very dull and dry.

Measure: Hair hydration

Time: 19 seconds

---

Description: Evaluate hair loss with the "pull sign" by pulling the hair without the intention of plucking, daily in the morning (Daily, morning, 21 days).Categories 1. <5 hairs on hand. 2. 5-10 hairs. 3.> 10 hairs.

Measure: Hair loss

Time: 20 seconds

---

Description: Targeted search for one or more asymptomatic sudden onset decalvary patches throughout the hair territory (Daily, morning, 21 days). Categories: 1. Without decalvary plates. 2. With regional decalvary plates. 3. Generalized alopecia areata.

Measure: Decalvary patches

Time: 10 seconds

---

Description: Inspect the scalp for lesions (Daily, morning, 21 days). Categories: 1.No injuries. 2. Flaking. 3.Erythema. 4.Infection. 5. Bleeding.

Measure: Scalp lesions

Time: 15 seconds

---

Description: Ask about itching of the scalp (Daily, morning, 21 days). Categories: 1.Without itching. 2.Itching.

Measure: Itching scalp

Time: 10 seconds

---

Description: Evaluate the absence or loss of eyelashes, daily in the morning. Categories: 1.Without alterations. 2.White spaces. 3. Fall when exploring.

Measure: Loss of eyelashes

Time: 15 seconds

---

Description: Evaluate the absence or drooping of eyebrows (Daily, morning, 21 days). Categories: 1. Without alterations. 2.White spaces. 3. Fall when exploring.

Measure: Drooping of eyebrows

Time: 10 seconds

---

Description: Evaluate eyelid edema (Daily, morning, 21 days). Categories: 1. Without edema. 2. With edema

Measure: Eyelid edema

Time: 5 seconds

---

Description: Check the vascularity of the sclera (Daily, morning, 21 days). Categories: 1.White sclera. 2.Small blood vessels. 3. Large blood vessels. 4.Hemorrhage.

Measure: Vascularity of the sclera

Time: 10 seconds

---

Description: Assess ocular hydration (Daily, morning, 21 days). Categories: 1.Hydrated. 2.Dry mucus. 3.Absence of tears. 4 sunken eyes

Measure: Ocular hydration

Time: 15 seconds

---

Description: Evaluate sclera color, daily in the morning. Categories: 1.White. 2. Localized yellow. 3.General yellow. 4.Other colors.

Measure: Sclera color

Time: 10 seconds

---

Description: Evaluation of smell, presenting non-irritating odors and ask if it distinguishes them (Daily, morning, 21 days). Categories: 1.Normal. 2. Hyposmia. 3.Anosmia.

Measure: Sense of smell

Time: 30 seconds

---

Description: Evaluate the presence of irritation in the nostrils (Daily, morning, 21 days). Categories: 1.No irritation. 2.With irritation.

Measure: Irritation in the nostrils

Time: 10 seconds

---

Description: Assess nasal secretions (Daily, morning, 21 days). Categories: 1. Absence. 2.Transparent. 3.Of other colors. 4.With blood.

Measure: Nasal secretions

Time: 10 seconds

---

Description: Evaluate the presence of cheilitis (Daily, morning, 21 days). Categories: 1.Without cheilitis. 2.Unilateral. 3.Bilateral. 4.With ulcers.

Measure: Cheilitis

Time: 5 seconds

---

Description: Assess taste buds (Daily, morning, 21 days). Categories: 1. Normal. 2. Inflamed. 3. Painful. 4. Bleeding.

Measure: Taste buds

Time: 10 seconds

---

Description: Evaluate the presence of the saw edge of the tongue (Daily, morning, 21 days). Categories 1.Normal. 2.Flat 3.With serrated edge.

Measure: Saw edge of the tongue

Time: 10 seconds

---

Description: Look for changes in the body of the tongue (Daily, morning, 21 days). Categories: 1.No alterations. 2.Geographic. 3.Fissured.

Measure: Changes in the body of the tongue

Time: 10 seconds

---

Description: Look for changes in the thickness of the tongue (Daily, morning, 21 days). Categories: 1. Normal thickness. 2. Abnormal thickness, swollen.

Measure: Thickness of the tongue

Time: 5 seconds

---

Description: Assess the presence of salivation (Daily, morning, 21 days). Categories: 1.Normal. 2.Excessive salivation. 3 absent.

Measure: Salivation

Time: 10 seconds

---

Description: Evaluate the taste presenting food from their tray and ask if you distinguish the flavors (Daily, morning, 21 days). Categories: 1.Conserved. 2. Hypogeusia. 3.Ageusia.

Measure: Taste

Time: 30 seconds

---

Description: Evaluation of the gums (Daily, morning, 21 days). Categories: 1.Normal. 2.Hypersensitive 3.Inflamed. 4. Bleeding.

Measure: Gums

Time: 10 seconds

---

Description: Evaluation of skin sensitivity (Daily, morning, 21 days). Categories: 1.Normal. 3.Altered sensitivity. 3.Painful.

Measure: Skin sensitivity

Time: 30 seconds

---

Description: Assess the presence of lesions (Daily, morning, 21 days). Categories: 1. No lesions. 2.Dermatitis. 3. Open lesions.

Measure: Skin lesions

Time: 10 seconds

---

Description: Assess skin hydration (Daily, morning, 21 days). Categories: 1.Normal. 2.Fat. 3.Dry.

Measure: Skin hydration

Time: 10 seconds

---

Description: Evaluate skin texture (Daily, morning, 21 days). Categories: 1.Lisa. 2.Rugose. 3.Descamative

Measure: Skin texture

Time: 10 seconds

---

Description: Check for loss or absence of body hair (Daily, morning, 21 days). Categories: 1.Present. 2.Fall. 3.Absence.

Measure: Absence of body hair

Time: 10 seconds

---

Description: Evaluate by finger pressure the 7th cervical hypersensitivity (Every 2 days, morning, 21 days). Categories: 1. It does not cause pain. 2. It causes pain.

Measure: Cervical pain points

Time: 5 seconds

---

Description: Search for hypersensitivity on the inside of the forearm (Every 2 days, morning, 21 days)

Measure: Forearm pain points

Time: 5 seconds

---

Description: Ask if he presents odynophagia (Daily, 2 shifts, 21 days). Categories: 1.Absent. 2. Present.

Measure: Odynophagia

Time: 5 seconds

---

Description: Evaluation of the presence of cough (Daily, 2 shifts, 21 days). Categories: 1.Absent. 2.Productive. 3.Dry

Measure: Cough

Time: 5 seconds.

---

Description: Evaluation of the presence of sneezing (Daily, 2 shifts, 21 days). Categories: 1. Absent. 2. Present.

Measure: Sneezing

Time: 5 seconds

---

Description: Respiration rhythm evaluation (Daily, 2 shifts, 21 days). Categories: 1. Normal. 2.Altered.

Measure: Respiration rhythm

Time: 1 minute

---

Description: Assessment of abdominal breathing (Daily, 2 shifts, 21 days). Categories: 1.Absent. 2. Present.

Measure: Abdominal breathing

Time: 20 seconds

---

Description: Evaluation of the use of accessory muscles when breathing (Daily, 2 shifts, 21 days). Categories: 1.Absent. 2. Present.

Measure: Use of accessory muscles when breathing

Time: 10 seconds

---

Description: Evaluate the presence of xiphoid retraction when breathing (Daily, 2 shifts, 21 days). Categories: 1. Absent. 2. Present.

Measure: Xiphoid retraction when breathing

Time: 10 seconds

---

Description: Assess the presence and degree of dyspnea (Daily, 2 shifts, 21 days). Categories: 1.Without difficulty. 2.When standing. 3.When sitting. 2.When speaking, 3.Lying down.

Measure: Dyspnea

Time: 10 seconds

---

Description: Evaluate the abdomino-cutaneous reflexes (Diary, verpertino, 21 days). Categories: 1. Present. 2. Absent

Measure: Abdomino-cutaneous reflexes

Time: 20 seconds

---

Description: Assess rebound sensitivity (Daily, verpertino, 21 days). Categories: 1. Without sensitivity. 2. With sensitivity.

Measure: Rebound sensitivity

Time: 15 seconds

---

Description: Evaluate the presence of pain in the right hypochondrium. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Right hypochondrium

Time: 5 seconds

---

Description: Evaluate the presence of pain in the epigastrium. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Epigastrium

Time: 5 seconds

---

Description: Evaluate the presence of pain in the left hypochondrium. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Left hypochondrium

Time: 5 seconds

---

Description: Assess the presence of pain in the right flank. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Right flank

Time: 5 seconds

---

Description: Assess the presence of pain in the mesogastrium (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Mesogastrium

Time: 5 seconds

---

Description: Evaluate the presence of pain in the left flank. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Left flank

Time: 5 seconds

---

Description: Evaluate the presence of pain in the right iliac fossa. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Right iliac fossa.

Time: 5 seconds

---

Description: Evaluate the presence of pain in the hypogastrium. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Hypogastrium

Time: 5 seconds

---

Description: Assess the presence of pain in the left iliac fossa. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Left iliac fossa.

Time: 5 seconds

---

Description: Ask for the presence of vomiting in 24 hours (Daily, evening, 21 days). Categories: 1. Absent. 2. Present.

Measure: Vomiting

Time: 5 seconds

---

Description: Ask about the presence of appetite (Daily, evening, 21 days). Categories: 1. Increased appetite. 2.Normal 3.Hypoexia. 4.Anorexia.

Measure: Appetite

Time: 5 seconds

---

Description: Ask about the presence of reflux (Daily, evening 21 days). Categories: 1. Absent. 2. After eating (specify food). 3. At bedtime. 4. Sudden

Measure: Reflux

Time: 5 seconds

---

Description: Ask about the presence of more common burps than normal (Daily, evening, 21 days). Categories: 1.Normales 2. Augmented.

Measure: Burps

Time: 5 seconds

---

Description: Evaluation of defecation by means of bowel movements with the Bristol scale (Daily, evening, 21 days). Categories: 1.Normal (T3, T4) 2.Constipation (T1, T2). 3. Diarrhea (T5, T6, T7).

Measure: Bristol scale

Time: 10 seconds

---

Description: Evaluation of hair loss on legs (Every 2 days, evening, 21 days) Categories: 1. Without alterations. 2.White spaces. 3. Fall when exploring.

Measure: Hair loss on legs

Time: 10 seconds

---

Description: Evaluation of the sensitivity of the tibial tract (Every 2 days, evening, 21 days) Categories: 1. No pain. 2.Painful.

Measure: Sensitivity of the tibial tract

Time: 10 seconds

---

Description: Assessment of nail strength (Every 2 days, evening, 21 days). Categories: 1. Strong. 2. Brittle. 3.Not assessable.

Measure: Nail strength

Time: 10 seconds

---

Description: Check the presence of fungus in the nails of the hands (Every 2 days, evening, 21 days). Categories: 1. Absent. 2. Present. 3.Not assessable.

Measure: Fungus in the nails of the hands

Time: 10 seconds

---

Description: Look for the presence of white stripes on the nails (Every 2 days, evening, 21 days). Categories: 1. Absent. 2. Present. 3.Not assessable.

Measure: White stripes on the nails

Time: 5 seconds

---

Description: Look for the presence of white spots on the nails (Every 2 days, evening, 21 days). Categories: 1. Absent. 2. Present. 3.Not assessable.

Measure: White spots on the nails

Time: 5 seconds

---

Description: Look for the presence of ridges on the nails (Every 2 days, evening, 21 days). Categories: 1.Lisas. 2.With ridges. 3.Not assessable.

Measure: Ridges on the nails

Time: 5 seconds

---

Description: Taking the height (at the beginning of the protocol). Measure in cm.

Measure: Height

Time: 1 minute

---

Description: Weight taking (Every 2 days, 2 hours after breakfast, for 21 days). Measured in kg.

Measure: Weight

Time: 1 minute

---

Description: Calculation of BMI (Every 2 days, morning, for 21 days). Measured in kg / m2.

Measure: BMI

Time: 30 seconds

---

Description: Measurement by blood sample of erythrocytes (Every 3 days, for 21 days). Measured at 10 ^ 6 / uL.

Measure: Erythrocytes

Time: 20 seconds

---

Description: Measurement by blood sample of hemoglobin (Every 3 days, for 21 days). Measured in g / dL.

Measure: Hemoglobin

Time: 20 seconds

---

Description: Measurement by blood sample of hematocrit (Every 3 days, for 21 days). Measurement in %.

Measure: Hematocrit

Time: 20 seconds

---

Description: Measurement by blood sample of mean corpuscular volume (MCV) (Every 3 days, for 21 days). Measured in fL.

Measure: Mean corpuscular volume

Time: 20 seconds

---

Description: Measurement by blood sample of mean hemoglobin concentration (Every 3 days, for 21 days). Measurement in pg.

Measure: Mean hemoglobin concentration

Time: 20 seconds

---

Description: Measurement every 3 days by blood sample of mean corpuscular hemoglobin concentration (Every 3 days, for 21 days). Measured in g / dL

Measure: Mean corpuscular hemoglobin concentration

Time: 20 seconds

---

Description: Erythrocyte distribution width measurement by blood sample (Every 3 days, for 21 days). Measured in%.

Measure: Erythrocyte distribution width

Time: 20 seconds

---

Description: Measurement by blood sample of the hemoglobin distribution index (Every 3 days, for 21 days). Measured in g / dL.

Measure: Hemoglobin distribution index

Time: 20 seconds

---

Description: Measurement by blood sample of leukocytes (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Leukocytes

Time: 20 seconds

---

Description: Measurement by blood sample of neutrophils (%) (Every 3 days, for 21 days). Measurement in%

Measure: Neutrophils (%)

Time: 20 seconds

---

Description: Measurement by blood sample of neutrophils (#) (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Neutrophils (#)

Time: 20 seconds

---

Description: Measurement by blood sample of lymphocytes (%) (Every 3 days, for 21 days). Measurement in%

Measure: Lymphocytes (%)

Time: 20 seconds

---

Description: Measurement by blood sample of lymphocytes (#) (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Lymphocytes (#)

Time: 20 seconds

---

Description: Measurement by blood sample of monocytes (%) (Every 3 days, for 21 days). Measurement in%

Measure: Monocytes (%)

Time: 20 seconds

---

Description: Measurement by blood sample of monocytes (#) (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Monocytes (#)

Time: 20 seconds

---

Description: Measurement by blood sample of eosinophils (%) (Every 3 days, for 21 days). Measurement in%

Measure: Eosinophils (%)

Time: 20 seconds

---

Description: Measurement by blood sample of eosinophils (#) (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Eosinophils (#)

Time: 20 seconds

---

Description: Measurement by blood sample of basophils (%) (Every 3 days, for 21 days). Measurement in%

Measure: Basophils (%)

Time: 20 seconds

---

Description: Measurement by blood sample of basophils (#) (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Basophils (#)

Time: 20 seconds

---

Description: Measurement of prothrombin time (PT) by blood sample (Every 3 days, for 21 days). Measure in seconds

Measure: Prothrombin time

Time: 20 seconds

---

Description: Measurement by blood sample of INR (Every 3 days, for 21 days). Measure in units

Measure: INR

Time: 20 seconds

---

Description: Measurement by control blood sample (100-50) (Every 3 days, for 21 days). Measure in seconds

Measure: Control blood sample (100-50) 1

Time: 20 seconds

---

Description: Measurement by blood sample of partial thromboplastin time (Every 3 days, for 21 days). Measure in seconds

Measure: Partial thromboplastin time

Time: 20 seconds

---

Description: Measurement by control blood sample (100-50) (Every 3 days, for 21 days). Measure in seconds

Measure: Control blood sample (100-50) 2

Time: 20 seconds

---

Description: Measurement by blood sample of platelets. Measured in 10 ^ 3 / μL

Measure: Platelets

Time: 20 seconds

---

Description: Measurement by blood sample of mean platelet volume (MPV) (Every 3 days, for 21 days). Measured in fL.

Measure: Mean platelet volume

Time: 20 seconds

---

Description: Initial screening test to diagnose patients with signs or symptoms suggestive of venous thromboembolism, it is a marker of endogenous fibrinolysis. Measurement by blood sample of dimer D (Every 3 days, for 21 days). Measured in ng / mL

Measure: D-dimer

Time: 20 seconds

---

Description: Sulfur amino acid that originates in the metabolism of methionine, and is very aggressive for the arterial endothelium. Measurement by blood sample of homocysteine levels (Every 3 days, for 21 days). Measured in µmol / l.

Measure: Homocysteine

Time: 20 seconds

---

Description: Fat-soluble vitamin involved in calcium homeostasis and bone metabolism, regulation of genes involved in the regulation of cell proliferation, cell differentiation and apoptosis. It has been suggested that it exerts immunomodulatory and antiproliferative effects. Measurement by blood sample of levels of 25-hydroxycholecalciferol (Every 3 days, for 21 days). Measured in nmol / L

Measure: Vitamin D

Time: 20 seconds

---

Description: Measurement by blood sample of calcium (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Calcium

Time: 20 seconds

---

Description: Measurement by blood sample of phosphorus (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Phosphorus

Time: 20 seconds

---

Description: Measurement by blood sample of magnesium (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Magnesium

Time: 20 seconds

---

Description: Measurement by blood sample of sodium (Every 3 days, for 21 days). Measured in mmol / L.

Measure: Sodium

Time: 20 seconds

---

Description: Measurement by blood sample of potassium (Every 3 days, for 21 days). Measured in mmol / L.

Measure: Potassium

Time: 20 seconds

---

Description: Measurement by blood sample of chlorine (Every 3 days, for 21 days). Measured in mmol / L.

Measure: Chlorine

Time: 20 seconds

---

Description: A measure of the concentration of free glucose in the blood, serum or blood plasma. Measured in mg / dL.

Measure: Blood glucose

Time: 20 seconds

---

Description: Taking a blood sample of total cholesterol (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Total cholesterol

Time: 20 seconds

---

Description: Taking a blood sample of triglycerides (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Triglycerides

Time: 20 seconds

---

Description: Taking a blood sample of LDL cholesterol (Every 3 days, for 21 days). Measured in mg / dL.

Measure: LDL cholesterol

Time: 20 seconds

---

Description: Taking a blood sample for HDL cholesterol (Every 3 days, for 21 days). Measured in mg / dL.

Measure: HDL cholesterol

Time: 20 seconds

---

Description: Taking a blood sample to evaluate the level of aspartate aminotransferase (Every 3 days, for 21 days). Measured in U / L.

Measure: Aspartate aminotransferase

Time: 20 seconds

---

Description: Taking a blood sample to evaluate the level of alanine aminotransferase (Every 3 days, for 21 days). Measured in U / L.

Measure: Alanine aminotransferase

Time: 20 seconds

---

Description: Taking a blood sample to evaluate the total bilirubin level (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Total bilirubin

Time: 20 seconds

---

Description: Taking a blood sample to evaluate the level of direct bilirubin (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Direct bilirubin

Time: 20 seconds

---

Description: Taking a blood sample to evaluate the level of indirect bilirubin (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Indirect bilirubin

Time: 20 seconds

---

Description: Taking a blood sample to evaluate the level of alkaline phosphatase (Every 3 days, for 21 days). Measured in U / L.

Measure: Alkaline phosphatase

Time: 20 seconds

---

Description: Taking a blood sample to evaluate the level of total proteins (Every 3 days, for 21 days). Measured in g / dL.

Measure: Total proteins

Time: 20 seconds

---

Description: Taking a blood sample to evaluate the albumin level (Every 3 days, for 21 days). Measured in g / dL.

Measure: Albumin level

Time: 20 seconds

---

Description: Taking a blood sample to evaluate the globulin level (Every 3 days, for 21 days). Measured in g / dL.

Measure: Globulin level

Time: 20 seconds

---

Description: Taking a blood sample to evaluate the A / G ratio (Every 3 days, for 21 days). Measured in g / dL.

Measure: A / G ratio

Time: 20 seconds

---

Description: ake a blood sample to evaluate the levels of urea nitrogen (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Urea nitrogen

Time: 20 seconds

---

Description: Take a blood sample to evaluate urea levels (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Urea

Time: 20 seconds

---

Description: Take a blood sample to evaluate creatitine levels (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Creatitine

Time: 20 seconds

---

Description: Take a blood sample to evaluate uric acid levels (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Uric acid

Time: 20 seconds

---

Description: Take a blood sample to evaluate ferritin levels (Every 3 days, for 21 days). Measured in ng/mL.

Measure: Ferritin

Time: 20 seconds

---

Description: Take a blood sample to evaluate fibrinogen levels (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Fibrinogen

Time: 20 seconds

---

Description: Take a blood sample to evaluate the levels of C-reactive protein (Every 3 days, for 21 days). Measured in mg/L.

Measure: C-reactive protein

Time: 20 seconds

---

Description: Use of the appropriate procedures established in the NSS indications (Specific supplementation scheme, based on 1 sachet, intramuscular B vitamins and probiotics). Quantification of empty supplement envelopes (Daily, 2 shifts, 21 days). Categories: 1.On empty. 2. About half. 3.Full.

Measure: Adherence to the Nutritional Support System (NSS)

Time: 5 seconds

---

Description: Quantification of the time from when the envelope is added in water, until everything is consumed (Daily, 2 shifts, 21 days). Categories: 1. Less than 15 minutes. 2. More than 15 minutes.

Measure: Intake time

Time: 15 minutes

---

Description: Quantification of the amount of prepared "NSS" he drink (Daily, 2 shifts, 21 days). Categories: 1.All the preparation. 2.Half. 3.Nothing.

Measure: Amount of prepared "NSS" he drink

Time: 15 minutes

---

Description: In-person verification of the taking of the floratil pill and observe that they do not vomit it (Daily, 2 shifts, first 6 days). Categories: 1. The pill is taken. 2.The pill is not taken.

Measure: Taking of the "floratil" pill

Time: 20 seconds

---

Description: Corroborate in person the correct application of the neurobion injection (Daily, evening, first 5 days). Categories: 1. It applies. 2.Not applicable.

Measure: Neurobion injection

Time: 1 minute

---

Description: Unit of thermal energy, which is equal to the amount of heat needed to raise the temperature of 1 gram of water by 1 degree Celsius. Unit of measurement of the energy content of food that consists of the number of calories that a given weight of food can develop in the tissues, or in the physical work equivalent to them. Calculate the grams that the food has of each macronutrient and multiply it by the energy intake. Based on the Mexican Equivalent Food System. Number in Kcal.

Measure: Diet calories

Time: 15 minutes

---

Description: Evaluate the amount of trans fat in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Trans fat in the diet

Time: 2 minutes

---

Description: Evaluate the amount of saturated fat in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Saturated fat in the diet.

Time: 2 minutes

---

Description: Evaluate the amount of monounsaturated fats in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Monounsaturated fats in the diet

Time: 2 minutes

---

Description: Evaluate the amount of polyunsaturated fat in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Polyunsaturated fat in the diet

Time: 2 minutes

---

Description: Evaluate the amount of protein of animal origin in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Protein of animal origin in the diet

Time: 2 minutes

---

Description: Evaluate the amount of plant-based protein in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Plant-based protein in the diet

Time: 2 minutes

---

Description: Accurate record of the amount of fluids administered. Evaluate the income of 24 hrs. (Daily, 2 shifts, 21 days). Number in ml.

Measure: Fluid balance (income)

Time: 5 minutes

---

Description: Accurate record of the amount of liquids eliminated by any means. Evaluate the expenses of 24 hrs. (Daily, 2 shifts, 21 days). Number in ml.

Measure: Fluid balance (outcome)

Time: 5 minutes

---

Description: Need or desire to eat. Observe the percentage of the tray with food that was ingested (Daily, 2 shifts, 21 days). Categories: 1. 100% ingested. 2.75%. 3.50%. 4.25%.

Measure: Hungry

Time: 15 seconds

---

Description: Cardiovascular disease risk indicator. Measure with a tape measure with the patient standing, feet together, arms at the sides and the abdomen relaxed, encircling the abdomen at the level of the navel at the midpoint between the last rib and the iliac crest and without pressing, taking an inspiration deep, taking the measurement at the moment of expelling the air.

Measure: Abdominal circumference

Time: 1 minute

---

Description: It is used to know the nutritional status of the patient. It is obtained by measuring the middle part of the arm with a tape measure, taking as a reference the length between the point of the shoulder (acromion) and the head of the radius (olecranon). Take the circumference of the arm using a tape measure (every 2 days, 2 hours after breakfast, in the morning, for 21 days). Measure in mm.

Measure: Arm circumference.

Time: 3 minutes

---

Description: It is measured on the midline of the back of the arm (triceps) at 1 cm from the height of the midpoint of the arm. Taking triceps fold measuring tape and caliper (every 2 days, 2 hours after breakfast, morning, for 21 days)). Measure in mm.

Measure: Tricipital fold

Time: 3 minutes

---

Description: Calculation from arm circumference and triceps fold. Calculate it according to the formula proposed by Frisancho. (every 2 days, 2 hours after breakfast, morning, for 21 days). Measure in mm2.

Measure: Arm area

Time: 1 minute

---

Description: Set of peculiarities that characterize the individuals of a species, dividing them into male and female, and make possible a reproduction characterized by genetic diversification. Based on an official ID. Categories: 1. Male 2. Female

Measure: Biological sex

Time: 30 seconds

---

Description: Time elapsed from the birth of a living being to the moment the calculation is made. Based on an official ID. Number between 30 and 75.

Measure: Age

Time: 30 seconds

---

Description: Sugars attached to the surface of red blood cells, and according to their composition. Evaluate by blood sample. Categories: 1.A, 2. B, 3.AB 4.O.

Measure: AB0 system

Time: 2 minutes

---

Description: Protein in red blood cells or erythrocytes. Obtaining by blood sample. Categories: 1.Rh (+) 2.Rh (-).

Measure: Rh factor

Time: 2 minutes

---

Secondary Outcomes

Description: Record the use of proton pump inhibitors (omeprazole, pantoprazole) (daily, evening, for 21 days). Categories: 1.Not prescribed. 2.Prescribed.

Measure: Use of proton pump inhibitors

Time: 5 seconds

---

Description: Record the use of obesity medications (orlistat, acarbose, bile acid sequestrants, etc.) (daily, evening, for 21 days). Categories: 1.Not prescribed. 2.Prescribed.

Measure: Obesity medications

Time: 5 seconds

---

Description: Record the use of antiepileptic drugs (daily, evening, for 21 days). Categories: 1.Not prescribed. 2.Prescribed.

Measure: Use of antiepileptic drugs

Time: 5 seconds

---

Description: Record the use of oral contraceptives (daily, evening, for 21 days). Categories: 1.Not prescribed. 2.Prescribed.

Measure: Use of oral contraceptives

Time: 5 seconds

---

Description: Record the use of antimitotics (colchicine) (daily, evening, for 21 days). Categories: 1.Not prescribed. 2.Prescribed.

Measure: Use of antimitotics

Time: 5 seconds

---

Description: Chemical substance that kills or prevents the growth of certain classes of sensitive microorganisms. Record the antibiotics that are being administered. (daily, evening, for 21 days) Categories: 1.Not used. 2.Use of antibiotics (specify which)

Measure: Antibiotics

Time: 5 seconds

---

Description: Medicines whose main pharmacological effect is to relieve pain. Record the analgesics that are being administered (daily, evening, for 21 days). Categories: 1.Not used. 2.Use of analgesics (specify which)

Measure: Analgesics

Time: 5 seconds

---

Description: Drugs with anti-inflammatory and immunosuppressive effect. Record the corticosteroids that are being administered (daily, evening, for 21 days). Categories: 1.Not used. 2.Use of corticosteroids (specify which).

Measure: Corticosteroids

Time: 5 seconds

---

Description: Substance that causes the elimination of water and electrolytes from the body through urine. Record the diuretics that are being administered (daily, evening, for 21 days). Categories: 1.Not used. 2.Use of diuretics (specify which)

Measure: Diuretics

Time: 5 seconds

---

Description: Drugs used to lower blood pressure. Record the antihypertensive drugs that are being administered (daily, evening, for 21 days). Categories: 1.Not used. 2.Use of antihypertensives (specify which)

Measure: Antihypertensive

Time: 5 seconds

---

Description: Endogenous or exogenous substance that interferes with or inhibits blood clotting, creating an antithrombotic or prohemorrhagic state. Record the anticoagulants that are being administered (daily, evening, for 21 days). Categories: 1.Not used. 2.Use of anticoagulants (specify which)

Measure: Anticoagulants

Time: 5 seconds

---

Description: Medications that attend to a basic pathology and have not been considered in the previous variables. Record the medications that are being administered and have not been named before (daily, evening, for 21 days). Write the medications.

Measure: Other medications

Time: 5 seconds

---

Description: Disturbance of the normal state of the level of absorption acutely due to a pathological alteration. Record the acute alterations that affect the absorption of nutrients (daily, evening, for 21 days). Categories: 1.None. 2.Intolerance. 3. Allergies 4. Diarrhea 5. Infection or inflammation in any organ of the digestive system.

Measure: Acute alterations in the absorption of nutrients.

Time: 5 seconds

---

Description: Any alteration in the response to the action of the drug due to the concomitant reaction of another chemical substance. Side effects reported through the clinic and laboratory (daily, evening, for 21 days). Categories: 1.None. 2.Rash. 3.Head or dizziness. 4.Gastrointestinal pain. 5.Other (specify).

Measure: Drug interactions and adverse effects

Time: 5 seconds

---

Description: Artificial supply of oxygen (O2) in the inspired air; its main objective is tissue oxygenation. Check the quantity of liters that you have pre-written for 24 hours (daily, evening, for 21 days). Number of liters.

Measure: Oxygen therapy

Time: 5 seconds

---

Description: Attitude or disposition in emotional life. It is not a transitory emotional situation. It is a state, a way of staying, of being, whose duration is prolonged and fades over the rest of the psychic world. Assess the patient's state of mind (daily, evening, for 21 days). Categories: 1.Happy. 2.Relaxed. 3. Alert. 4. Annoying 5. Sad. 6.Tense. 7.Tired. 8.Depressed

Measure: Mood

Time: 5 seconds

---

Primary Outcomes

Description: Total number of people enrolled divided by the total number of people invited to participate (multiplied by 100 to calculate a percentage)

Measure: Recruitment Rate

Time: Pre-program (baseline)

---

Description: Percentage of people who completed the full program and all assessments

Measure: Completion Rate

Time: Through study completion, 12 weeks

---

Description: Percentage of people who attended program sessions (exercise and cognitive training components)

Measure: Attendance

Time: Throughout entire intervention (12 weeks, 2 sessions/week per group)

---

Description: Participant and instructors rating of program components and overall program (via hand-written questionnaire). Participants and instructors must rate their level of agreement (1 = strongly disagree, 2 = disagree, 3 = no opinion, 4 = agree, 5 = strongly agree) with various statements. The higher the rating, the greater the satisfaction. They also must rate if the difficulty of the program was optimal, somewhat easy or hard, or too easy or hard. They must also specify how much money they would be willing to spend on the program. They are also given an opportunity to record optional additional comments/recommendation.

Measure: Change in Participant and Instructor Rating of experience, satisfaction, and feasibility of program

Time: Mid-point (6 weeks) and post-program (12 weeks)

---

Description: Financial cost of running program (equipment purchased for study - cognitive training tablet and stands - and YMCA staff pay) as reported by researcher and YMCA staff

Measure: Cost of program

Time: Post-program (12 weeks)

---

Description: Self-reported biological sex (at birth) using basic demographics questionnaire

Measure: Sex

Time: Pre-program (baseline)

---

Description: One-on-one interview with researcher, answering broad questions about their experience in the program and study

Measure: Participant and Instructor perceived program experience and satisfaction

Time: Post-program (at 12 weeks)

---

Description: Experience of participants and instructors will also be observed by the researcher (observational notes will be taken by the researcher during each class). No names of participants and instructors will be recorded.

Measure: Participant and Instructor observer-perceived program experience and satisfaction

Time: Throughout entire intervention (12 weeks, 2 sessions/week per group)

---

Description: Self-reported years of formal education and training (training years for instructors only) using basic demographics questionnaire

Measure: Education

Time: Pre-program (baseline)

---

Description: Self-reported previous and current occupations using basic demographics questionnaire

Measure: Occupation

Time: Pre-program (baseline)

---

Description: Self-reported previous and current medical conditions using basic demographics questionnaire

Measure: Medical Condition

Time: Pre-program (baseline)

---

Description: Self-reported previous and current medications using basic demographics questionnaire

Measure: Medications

Time: Pre-program (baseline)

---

Description: Using the Montreal Cognitive Assessments (brief clinical tool) to assess visual/spatial abilities, working memory, executive functioning, language, abstraction, and orientation). Will be used to describe participants' baseline cognitive status (a score out of 30 is measured).

Measure: Montreal Cognitive Assessment (global cognitive function)

Time: Pre-program (baseline)

---

Description: Using the International Physical Activities Questionnaire (IPAQ) to assess physical activity level based on self-reported frequency and duration of job-related, house work-related, transportation-related, and leisure-related physical activities done in the past week. METS-minutes/week will be calculated and reported (i.e. take the number of minutes doing an activity in the past week and multiply by the appropriate metabolic equivalent, which will vary based on the intensity of the physical activity).

Measure: Physical Activity Level

Time: Pre-program (baseline)

---

Description: Using a cognitive activity scale (score of 0-4 per activity) that requires participants to self-report how often they typically engage in a variety of mentally stimulating activities (i.e. playing card games, reading, cooking, etc.) The more frequently they engage in the activity, the higher the score.

Measure: Participant cognitive activity

Time: Pre-program (baseline)

---

Description: Using a scale (score of 0-3 per group) that requires participants to self-report how often they typically interact (face-to-face or virtually) with different groups of people (i.e. their spouse, family, friends, co-workers, etc.). The more frequently they interact with the group, the higher the score.

Measure: Participant social activity

Time: Pre-program (baseline)

---

Description: Self-reported years of age using basic demographics questionnaire

Measure: Participant and Instructor Age

Time: Pre-program (baseline)

---

Secondary Outcomes

Description: STROOP task which assesses the length of time (seconds) it takes for a participant to correctly name a coloured square (test 1), read the name of a colour (test 2), and say the name of the colour that a word is printed in (test 3). Number of corrected and uncorrected errors are also recorded.

Measure: Change in Stroop Task Performance

Time: Pre-program (baseline) and post-program (12 weeks)

---

Description: Trails Making Test Part A and B. Part A assesses visual search (participants must connect numbered circles in ascending numerical order (1-2-3-etc). Part B assesses working memory and task-switching (participants must connect circles in ascending numerical and alphabetical order (1-A-2-B- etc.). Time to complete the tests (second) and errors (number) made during the tests are recorded.

Measure: Change in Trail Making Task Performance

Time: Pre-program (baseline) and post-program (12 weeks)

---

Description: Resting (seated) heart rate (beats per minute) using an automatic blood pressure cuff

Measure: Change in Resting Heart Rate

Time: Pre-program (baseline) and post-program (12 weeks)

---

Description: Resting (seated) blood pressure (millimeters of mercury) using an automatic blood pressure cuff

Measure: Change in Resting Systolic and Diastolic Blood Pressure

Time: Pre-program (baseline) and post-program (12 weeks)

---

Description: Using hand dynamometer (assessing grip strength in lbs) for right and left hand (two trials per hand)

Measure: Change in Grip Strength

Time: Pre-program (baseline) and post-program (12 weeks)

---

Description: Weight (using automatic scale to measure in lbs, converted to kg) and height (measured in feet and inches, converted to meters) measured and combined to provide BMI (kg/m^2)

Measure: Change in Body Mass Index (BMI)

Time: Pre-program (baseline) and post-program (12 weeks)

---

Description: Divide waist circumference (cm) by hip circumference (cm) to get ratio calculation

Measure: Change in Hip-to-Waist Circumference Ratio

Time: Pre-program (baseline) and post-program (12 weeks)

---

Description: Agility and functional balance will be assessed using the Timed Up-and-Go (participants stand up from a chair, walk 6 meters, turn around an object, walk back to chair, and sit down). Time to complete test is measured (seconds) and assessor's observational notes of performance are taken.

Measure: Change in Timed Up-and-Go Performance

Time: Pre-program (baseline) and post-program (12 weeks)

---

Description: Agility and functional balance will be assessed using the Four Square Step Test (participants must step over lines that are set up in a cross formation, creating 4 quadrants. They must step forward, backward, and side to side in a specific pattern (i.e. from quadrant 1 to quadrant 2, to quadrant 3, to quadrant 4). Time to complete test is recorded in seconds.

Measure: Change in Four Square Step Test Performance

Time: Pre-program (baseline) and post-program (12 weeks)

---

Description: Lower body strength will be assessed using the 5 Time Sit-to-Stand (participants must complete 5 sit-to-stands from a chair as fast as they can). Time to complete all 5 is recorded in seconds.

Measure: Change in Sit-to-Stand Performance

Time: Pre-program (baseline) and post-program (12 weeks)

---

Description: Functional fitness will be assessed using the 6 minute walk (participants walk along indoor track for 6 minutes). The number of laps achieved in 6 minutes is recorded. Assessor's observational notes of walking performance is also recorded.

Measure: Change in 6-minute walk test Performance

Time: Pre-program (baseline) and post-program (12 weeks)

---

Description: Well-being will be self-reported using the "Vitality-Plus Scale" (self-reported general health questionnaire - rating of sleep quality, appetite, general energy level, etc.). Participants rate their degree of health on a scale from 1 - 5 (the higher the rating, the better their perceived overall well-being).

Measure: Change in Overall Well-being

Time: Pre-program (baseline) and post-program (12 weeks)

---

Description: Bandura Scale (named after the researcher who developed it) - self-reported rating of confidence (0 - 100%) to continue exercising routinely in various hypothetical situations (i.e. if one is sick, if the weather is poor, etc). The greater the confidence, the higher the score

Measure: Change in Exercise-related Self-Efficacy

Time: Pre-program (baseline) and post-program (12 weeks)

---

Primary Outcomes

Measure: Difference in change in home SBP from baseline to week 12

Time: 12 weeks

---

Secondary Outcomes

Measure: Difference in change in clinic seated mean SBP from baseline to Week 12

Time: 12 weeks

---

Measure: Difference in change in clinic seated mean SBP from baseline to Week 6

Time: 6 weeks

---

Measure: Difference in change in clinic seated mean DBP from baseline to Week 12

Time: 12 weeks

---

Measure: Difference in change in clinic seated mean DBP from baseline to Week 6

Time: 6 weeks

---

Measure: Percentage of participants with clinic seated mean SBP <140 and DBP <90 mmHg at Week 12

Time: 12 weeks

---

Measure: Percentage of participants with clinic seated mean SBP <140 and DBP <90 mmHg at Week 6

Time: 6 weeks

---

Measure: Percentage of participants with clinic seated mean SBP <130 and DBP <80 mmHg at Week 12

Time: 12 weeks

---

Measure: Percentage of participants with clinic seated mean SBP <130 and DBP <80 mmHg at Week 6

Time: 6 weeks

---

Measure: Difference in change in home seated mean SBP from baseline to Week 6

Time: 6 weeks

---

Measure: Difference in change in home seated mean DBP from baseline to Week 12

Time: 12 weeks

---

Measure: Difference in change in home seated mean DBP from baseline to Week 6

Time: 6 weeks

---

Measure: Difference in change in trough home seated mean SBP from baseline to week 12

Time: 12 weeks

---

Measure: Difference in change in trough home seated mean SBP from baseline to Week 6

Time: 6 weeks

---

Measure: Percentage of participants with home seated mean SBP <135 and DBP <85 mmHg at Week 12

Time: 12 weeks

---

Measure: Percentage of participants with home seated mean SBP <135 and DBP <85 mmHg at Week 6

Time: 6 weeks

---

Measure: Percentage of participants with home seated mean SBP <130 and DBP <80 mmHg at Week 12

Time: 12 weeks

---

Measure: Percentage of participants with home seated mean SBP <130 and DBP <80 mmHg at Week 6

Time: 6 weeks

---

Other Outcomes

Description: Percentage of participants discontinued trial medication due to AE/SAE from baseline to week 12

Measure: Safety Outcomes

Time: 12 weeks

---

Description: Percentage of participants discontinued trial medication due to AE/SAE from baseline to Week 6

Measure: Safety Outcomes

Time: 6 weeks

---

Description: Percentage of participants with an SAE from baseline to Week 12

Measure: Safety Outcomes

Time: 12 weeks

---

Description: Percentage of participants with SAE from baseline to Week 6

Measure: Safety Outcomes

Time: 6 weeks

---

Description: Percentage of participants with symptomatic hypotension from baseline to Week 12

Measure: Safety Outcomes

Time: 12 weeks

---

Description: Percentage of participants with symptomatic hypotension from baseline to Week 6

Measure: Safety Outcomes

Time: 6 weeks

---

Description: Percentage of participants with serum sodium concentration below 135 mmol/l at Week 12

Measure: Safety Outcomes

Time: 12 weeks

---

Description: Percentage of participants with serum sodium concentration below 135 mmol/l at Week 6

Measure: Safety Outcomes

Time: 6 weeks

---

Description: Percentage of participants with serum sodium concentration above 145 mmol/l at Week 12

Measure: Safety Outcomes

Time: 12 weeks

---

Description: Percentage of participants with serum sodium concentration above 145 mmol/l at Week 6

Measure: Safety Outcomes

Time: 6 weeks

---

Description: Percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12

Measure: Safety Outcomes

Time: 12 weeks

---

Description: Percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6

Measure: Safety Outcomes

Time: 6 weeks

---

Description: Percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12

Measure: Safety Outcomes

Time: 12 weeks

---

Description: Percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6

Measure: Safety Outcomes

Time: 6 weeks

---

Description: Percentage of participants with eGFR drop of over 30% from baseline to Week 12

Measure: Safety Outcomes

Time: 12 weeks

---

Description: Percentage of participants with eGFR drop of over 30% from baseline to Week 6

Measure: Safety Outcomes

Time: 6 weeks

---

Primary Outcomes

Measure: Difference in change in home SBP from baseline to Week 4

Time: 4 weeks

---

Secondary Outcomes

Measure: Difference in change in clinic seated mean SBP from baseline to Week 4

Time: 4 weeks

---

Measure: Difference in change in clinic seated mean DBP from baseline to Week 4

Time: 4 weeks

---

Measure: Percentage of participants with clinic seated mean SBP <140 and DBP <90 mmHg at Week 4

Time: 4 weeks

---

Measure: Percentage of participants with clinic seated mean SBP <130 and DBP <80 mmHg at Week 4

Time: 4 weeks

---

Measure: Difference in change in home seated mean DBP from baseline to Week 4

Time: 4 weeks

---

Measure: Difference in change in trough home seated mean SBP from baseline to week 4

Time: 4 weeks

---

Measure: Difference in change in trough home seated mean DBP from baseline to week 4

Time: 4 weeks

---

Measure: Percentage of participants with home seated mean SBP <135 and DBP <85 mmHg at Week 4

Time: 4 weeks

---

Measure: Percentage of participants with home seated mean SBP <130 and DBP <80 mmHg at Week 4

Time: 4 weeks

---

Other Outcomes

Description: Percentage of participants discontinued trial medication due to AE/SAE from baseline to Week 4

Measure: Safety Outcomes

Time: 4 weeks

---

Description: Percentage of participants with an SAE from baseline to Week 4

Measure: Safety Outcomes

Time: 4 weeks

---

Description: Percentage of participants with symptomatic hypotension from baseline to Week 4

Measure: Safety Outcomes

Time: 4 weeks

---

Description: Percentage of participants with serum sodium concentration below 135 mmol/l at Week 4

Measure: Safety Outcomes

Time: 4 weeks

---

Description: Percentage of participants with serum sodium concentration above 145 mmol/l at Week 4

Measure: Safety Outcomes

Time: 4 weeks

---

Description: Percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 4

Measure: Safety Outcomes

Time: 4 weeks

---

Description: Percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 4

Measure: Safety Outcomes

Time: 4 weeks

---

Description: • Percentage of participants with eGFR drop of over 30% from baseline to Week 4

Measure: Safety Outcomes

Time: 4 weeks

---

Primary Outcomes

Description: Weekly participant attendance will be recorded as date, month and year.

Measure: Determine the feasibility of a synchronous web-based health education program, of OUR project.

Time: 4 weeks

---

Description: Investigator generated open-ended questions.

Measure: Determine the acceptability of a synchronous web-based health education program, of OUR project.

Time: 1 month

---

Description: Weight measured in pounds.

Measure: Change from baseline at 3 months weight.

Time: Baseline to 3 months

---

Description: Waist circumference measured in inches.

Measure: Change from baseline at 3 months waist circumference.

Time: Baseline to 3 months

---

Description: Self-blood pressure collection using an automatic home blood pressure monitor systolic and diastolic in mmHg

Measure: Change from baseline at 3 months blood pressure.

Time: Baseline to 3 months

---

Secondary Outcomes

Description: Perceived Stress Scale is a 10-item Likert scale questionnaire regarding stress over the past month with higher scores indicating higher levels of stress. Ranges 0-30.

Measure: Change from baseline stress at 3 months.

Time: baseline to 3 months

---

Description: Difficulties in Emotion Regulation Scale. This measure has 18 items, each measured on a 5-point rating scale. One total score will calculated by summing the individual item responses. Higher scores represent greater perceived difficulties in emotion regulation capabilities.

Measure: Change from baseline emotional regulation at 3 months.

Time: baseline to 3 months

---

Description: Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q). The DASH Q had 15 items eliciting responses regarding the consumption of DASH diet foods (e.g., fruits, nuts, and vegetables) in the past seven days. Higher score indicates greater DASH knowledge. Range 0-105.

Measure: Change from baseline dietary approaches to stop hypertension knowledge at 3 months.

Time: baseline to 3 months

---

Description: The Brief Resilience Scale contains 5 questions on a Likert type scale assessing the ability to "bounce back" from stressors. Scores will be summed and higher scores indicate higher resilience.

Measure: Change from baseline resilience at 3 months.

Time: baseline to 3 months

---

Description: All of Us Program COVID-19 COPE Survey contains items that are not scored on a summary scale, that include social distancing experiences, COVID-19 related symptoms, and COVID-19 related treatment. Descriptive statistics will be used to summarize participant's experiences.

Measure: Describe participant experience and health during the COVID-19 pandemic.

Time: Baseline

---

Other Outcomes

Description: The Repeatable Neuropsychiatric Battery (RBANS) will be collected. The RBANS consists of 12 subtests that assess cognitive domains such as Immediate and Delayed Memory, Language, Attention, and Visuospatial/Construction and takes about 30 minutes to administer. A total RBANS sum of index scores will be computed by age.

Measure: Explore the feasibility of collecting cognitive performance data (processing speed, attention, and executive function) via teleconference.

Time: baseline and 3 months

---

Primary Outcomes

Description: Decrease in a composite outcome of hospitalization and supplemental oxygen use at day 14 between treatment pairs.

Measure: Rate of hospitalizations and oxygen use

Time: 14 days

---

Primary Outcomes

Description: The primary objective of the study is to assess precision dosing of amlodipine to deliver reductions in blood pressure in participants with primary hypertension and inadequate BP control by up-titration of amlodipine in 1-2 mg increments.

Measure: Reductions in blood pressure in participants with primary hypertension and inadequate BP control by up-titration of amlodipine in 1-2 mg increments.

Time: 3 months

---

Secondary Outcomes

Description: Other clinically significant blood pressure measures which related to difference in measured blood pressure between baseline and EOS

Measure: Mean change in daily DBP

Time: 3 months

---

Description: Difference between mean changes of blood pressure between interventional and observational cohorts.

Measure: Difference between mean changes of blood pressure

Time: 3 months

---

Description: Reports of side effects using digital diary

Measure: Collect data on tolerability / side effects

Time: 3 months

---

Primary Outcomes

Description: Evaluate whether a nurse-led BSE intervention will result in a lower systolic and/or diastolic BP 12 months postpartum

Measure: Systolic and/or diastolic BP, in mmHg.

Time: 12 months

---

Description: Evaluate whether a nurse-led BSE intervention will result in a lower need for antihypertensive therapy

Measure: Use of antihypertensive therapy

Time: 12 months

---

Secondary Outcomes

Description: Evaluate whether a nurse-led BSE intervention will result in longer duration of exclusive breastfeeding

Measure: Duration of exclusive breastfeeding (weeks)

Time: 12 months

---

Description: Evaluate whether a nurse-led BSE intervention will result in higher rates of any continued breastfeeding at 6 months

Measure: The proportion who breastfeed (exclusive or non-exclusive)

Time: 12 months

---

Description: Evaluate whether a nurse-led BSE intervention will result in lower metabolic syndrome

Measure: Metabolic syndrome

Time: 12 months

---

Primary Outcomes

Description: Physical activity level assessed with International Physical Activity Questionnaire (IPAQ) long version. IPAQ long version asks work-related, transport, domestic and recreational physical activities. It categorizes physical activities vigorous, moderate and walking. It uses frequency and duration of activities. Every physical activity category has a point and better physical activity level is related with higher IPAQ scores.

Measure: Physical Activity

Time: 2 months

---

Secondary Outcomes

Description: It will assess with Short form 36 questionnaire. It assesses quality of life and it contains different parameters for example body function, pain, physical and mental health etc. Each subscale is evaluated between 0-100 points. A higher score indicates the better health.

Measure: Quality of Life Assesment

Time: 2 months

---

Description: Healthy lifestyle behavior will asssess with Healthy Life Style Behavior Scale. The reliability and validity of the scale has been studied in Turkey. The lowest score that can be obtained from these three sub-dimensions is 26 and the highest score that can be obtained is 104.Positivite healthy lifestyles related with higher scores.

Measure: Evaluation of Individuals Healthy Lifestyle Behaviors

Time: 2 months

---

Description: Hospital Anxiety and Depression Scale (HADS) will use.The HADS contains fourteen item. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains.

Measure: Anxiety and Depression Level

Time: 2 months

---

Primary Outcomes

Description: Monitored continuously during study enrollment period

Measure: Proportion of eligible participants who agree to participate

Time: Through completion of study enrollment, an average of 9 months

---

Description: Repeated measures analysis across 4 time-points (0-, 4-, 8-, and 12-months)

Measure: Average of home blood pressure values assessed over a 2-week period at 0-, 4-, 8-, and 12-months.

Time: 12 months

---

Description: Repeated measures analysis across 4 time-points (0-, 4-, 8-, and 12-months)

Measure: Number of days with at least 1 home blood pressure measurement assessed over a 2-week period at 0-, 4-, 8-, and 12-months.

Time: 12 months

---