Covid 19 Research using Clinical Trials (Home Page)
Usual CareWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (15)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1198 | Group Lifestyle Balance Wiki | 0.35 |
| drug2245 | Prone Wiki | 0.35 |
| drug3389 | online KKH Sports Singapore Program with Usual Care Wiki | 0.35 |
| drug2247 | Prone Positioning (PP) Wiki | 0.35 |
| drug625 | Cell therapy protocol 1 Wiki | 0.35 |
| drug626 | Cell therapy protocol 2 Wiki | 0.35 |
| drug90 | ARBs and/or ACE inhibitors Wiki | 0.35 |
| drug2625 | Siltuximab Wiki | 0.25 |
| drug309 | Ayurveda Wiki | 0.25 |
| drug3386 | observational Wiki | 0.20 |
| drug192 | Anakinra Wiki | 0.13 |
| drug2928 | Tocilizumab Wiki | 0.12 |
| drug703 | Colchicine Wiki | 0.11 |
| drug1743 | Methylprednisolone Wiki | 0.10 |
| drug2176 | Placebos Wiki | 0.09 |
Correlated MeSH Terms (10)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D063766 | Pediatric Obesity NIH | 0.14 |
| D009765 | Obesity NIH | 0.12 |
| D020521 | Stroke NIH | 0.10 |
| D055371 | Acute Lung Injury NIH | 0.07 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.07 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.06 |
| D018352 | Coronavirus Infections NIH | 0.06 |
| D013577 | Syndrome NIH | 0.04 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.03 |
| D011014 | Pneumonia NIH | 0.02 |
Correlated HPO Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001513 | Obesity HPO | 0.12 |
| HP:0001297 | Stroke HPO | 0.10 |
| HP:0002090 | Pneumonia HPO | 0.02 |
There are 8 clinical trials
Clinical Trials
1 SMART Trial: Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia
In community acquired pneumonia, corticosteroids have been shown to have potential benefit. However, the limited and variable use of adjunctive corticosteroids in critically ill patients is largely due to an inability to identify patients that will benefit from the use of anti-inflammatory medications. This study compares usual care to a novel biomarker-tailored steroid dosing algorithm for patients with community acquired pneumonia. In April 2020, in response to the SARS CoV-2 pandemic, we added a COVID-19 arm to this study. The study will evaluate the role of biomarker-titrated adjuvant corticosteroid administration compared to usual care in patients admitted to hospital with SARS CoV-2 (COVID-19) infection and acute respiratory failure.
NCT03852537 Pneumonia Drug: Methylprednisolone Other: Usual Care MeSH:Pneumonia
HPO:Pneumonia
Primary Outcomes
Description: A percentage of eligible patients adhered to the timely initiation (within 12 hours of emergency room admission) and daily corticosteroid treatment according to ESICM/SCCM clinical practice guideline (control group) or biomarker concordance (intervention group)
Measure: Feasibility of the timely initiation of corticosteroids and implementation of biomarker-titrated corticosteroid dosing: percentage of eligible patients adhered to the timely initiation Time: Within 30 days of enrollment in study.
Secondary Outcomes
Description: Death from any cause
Measure: Mortality Time: Within 30 days and 90 days of study enrollment
Description: Progression of disease is defined by the need for high flow nasal cannula oxygen, noninvasive or invasive ventilation. Given the proliferation of high flow nasal cannula oxygen use in lieu of mechanical ventilation, instead of ventilator-free days the investigators opt for using advanced respiratory support free days where "advanced respiratory support" includes both invasive and noninvasive mechanical ventilation and the high flow nasal cannula oxygen.
Measure: Progression of disease Time: Within hospitalization or 30 days of study enrollment (whichever is sooner)
Description: Measured by respiratory component of SOFA at time of ICU admission, after 24 hours, after 48 hours and after 72 hours and by the organ failure free days. In the absence of daily arterial blood gas analysis, PaO2/FiO2 ratio will be replaced by SpO2/FiO2 ratio
Measure: Evolution of respiratory failure Time: Within 72 hours of enrollment in study.
Description: Assessed by renal component of Sequential Organ Failure Assessment (SOFA) Score score. This is a scale from 0-4 (with 0 indicating no renal failure and 4 indicating severe renal failure).
Measure: Evolution of kidney failure Time: Within 72 hours of enrollment in study.
Description: Assessed by cardiac component of Sequential Organ Failure Assessment (SOFA) Score score. This is a scale from 0-4 (with 0 indicating no cardiovascular failure and 4 indicating severe cardiovascular failure).
Measure: Evolution of shock Time: Within 72 hours of enrollment in study.
Description: In hospital and in ICU
Measure: Length of stay Time: From time of study enrollment up to discharge from hospital, to a maximum of 1 year.
Description: Number of participants who have hyperglycemia while receiving corticosteroids. Hyperglycemia is defined as a consistently elevated blood sugar level requiring insulin administration.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Hyperglycemia Time: Up to day +5 following study enrollment.
Description: Number of participants who develop delirium while receiving corticosteroids. Delirium will be assessed by Confusion Assessment Method for the ICU (CAM-ICU) measurement tool. The CAM-ICU is a binary (yes/no) scale for assessing the presence of delirium.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Delirium Time: Up to day +5 following study enrollment.
Description: Number of participants who develop secondary infections during and after steroid therapy. A secondary infection is defined as a new infection that develops after initiation of corticosteroid therapy, until 5 days after steroids are discontinued.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Secondary Infection Time: Up to day +14 following study enrollment.
2 Efficacy of an Evidence-based Healthy Lifestyle Intervention for People Following CVA
Primary Outcomes
Description: A percentage of eligible patients adhered to the timely initiation (within 12 hours of emergency room admission) and daily corticosteroid treatment according to ESICM/SCCM clinical practice guideline (control group) or biomarker concordance (intervention group)
Measure: Feasibility of the timely initiation of corticosteroids and implementation of biomarker-titrated corticosteroid dosing: percentage of eligible patients adhered to the timely initiation Time: Within 30 days of enrollment in study.Secondary Outcomes
Description: Death from any cause
Measure: Mortality Time: Within 30 days and 90 days of study enrollmentDescription: Progression of disease is defined by the need for high flow nasal cannula oxygen, noninvasive or invasive ventilation. Given the proliferation of high flow nasal cannula oxygen use in lieu of mechanical ventilation, instead of ventilator-free days the investigators opt for using advanced respiratory support free days where "advanced respiratory support" includes both invasive and noninvasive mechanical ventilation and the high flow nasal cannula oxygen.
Measure: Progression of disease Time: Within hospitalization or 30 days of study enrollment (whichever is sooner)Description: Measured by respiratory component of SOFA at time of ICU admission, after 24 hours, after 48 hours and after 72 hours and by the organ failure free days. In the absence of daily arterial blood gas analysis, PaO2/FiO2 ratio will be replaced by SpO2/FiO2 ratio
Measure: Evolution of respiratory failure Time: Within 72 hours of enrollment in study.Description: Assessed by renal component of Sequential Organ Failure Assessment (SOFA) Score score. This is a scale from 0-4 (with 0 indicating no renal failure and 4 indicating severe renal failure).
Measure: Evolution of kidney failure Time: Within 72 hours of enrollment in study.Description: Assessed by cardiac component of Sequential Organ Failure Assessment (SOFA) Score score. This is a scale from 0-4 (with 0 indicating no cardiovascular failure and 4 indicating severe cardiovascular failure).
Measure: Evolution of shock Time: Within 72 hours of enrollment in study.Description: In hospital and in ICU
Measure: Length of stay Time: From time of study enrollment up to discharge from hospital, to a maximum of 1 year.Description: Number of participants who have hyperglycemia while receiving corticosteroids. Hyperglycemia is defined as a consistently elevated blood sugar level requiring insulin administration.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Hyperglycemia Time: Up to day +5 following study enrollment.Description: Number of participants who develop delirium while receiving corticosteroids. Delirium will be assessed by Confusion Assessment Method for the ICU (CAM-ICU) measurement tool. The CAM-ICU is a binary (yes/no) scale for assessing the presence of delirium.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Delirium Time: Up to day +5 following study enrollment.Description: Number of participants who develop secondary infections during and after steroid therapy. A secondary infection is defined as a new infection that develops after initiation of corticosteroid therapy, until 5 days after steroids are discontinued.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Secondary Infection Time: Up to day +14 following study enrollment.The purpose of this RCT is to examine the efficacy of the Group Lifestyle Balance (GLB) program adapted for people with stroke (CVA) on primary (weight) and secondary outcomes at 3, 6, 12 months from enrollment into the program.
NCT03873467 Stroke Behavioral: Group Lifestyle Balance Other: Usual Care MeSH:Stroke
HPO:Stroke
Primary Outcomes
Description: Will be obtained using the same scale over the study period that is accessible to people with and without a mobility device (e.g., walker; wheelchair).
Measure: Change in weight Time: Baseline, 3, 6, 12 months
Secondary Outcomes
Description: Accelerometers will be worn by participants for two weeks around each study visit to objectively track physical activity participation (amount and intensity). Participants will be given the Actigraph accelerometer at the beginning of the study and will be provided with verbal and written instructions.
Measure: Physical Activity Time: Baseline, 3, 6, 12 months
Description: Arm circumference measured at mid-upper arm following ACSM guidelines. A total of three measurements will be taken and an average of the three will be used. Measurements will be taken in centimeters.
Measure: Arm Circumference Time: Baseline, 3, 6, 12 months
Description: Using an automatic cuff (average of three readings, patient seated) diastolic and systolic scores will be recorded
Measure: Blood Pressure Time: Baseline, 3, 6, 12 months
Description: Fasting venous sample will be obtained. Coordinators are trained phlebotomists.
Measure: Cholesterol Time: Baseline, 3, 6, 12 months
Description: The Framingham Heart Study diabetes risk score will be calculated using predictors including age, gender, fasting glucose, BMI, HDL cholesterol and triglyceride levels, blood pressure, and parental history. Risk score calculator and regression model are free and used in GLB weight-loss trials. Risk score calculator and regression model are free and used in GLB weight-loss studies. Each risk predictor is assigned points ranging from 2-10. Risk factors are combined and a total score is calculated, with higher scores designating greater 8-year risk.The age range for this score is 45 years to 64 years, and therefore only individuals within this age will have calculated scores. Furthermore, the minimum cut-off score is 3.
Measure: Risk of Diabetes Time: Baseline, 3, 6, 12 months
Description: Assesses walking speed in (m/s) which is correlated to mobility in the community, capacity to perform ADLs, risk of falls, re-hospitalization, and risk of cognitive decline.
Measure: 10 Meter Walk Test (10MWT) Time: Baseline, 3, 6, 12 months
Description: Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity. Endurance is essential to participate in community-based activities.
Measure: 6 Minute Walk Test (6MWT) Time: Baseline, 3, 6, 12 months
Description: The Multidimensional Scale of Perceived Social Support (MSPSS) is comprised of 12 questions with a 4-item subscale. The MSPSS is designed to assess perception of social support from friends, family, and significant others
Measure: Perceived Social Support Time: Baseline and 12 months
Description: Measure includes 28 items that assess health practices among people with disabilities and yields a total Health Practices score plus 4 subscales scores regarding Exercise, Nutrition, Health Practices, and Psychological Well Being. Items are rated on a 5-point scale from 0 'not at all' to 4 'completely.' Scores range from 0-28 with higher scores indicating higher exercise self-efficacy.
Measure: Self-reported activities of health using the Self-Rated Abilities for Health Practice scale Time: Baseline and 12 months
Description: Walk Score® is publicly available and measures the walkability of any address using a patented system. For each address, Walk Score ® analyzes hundreds of walking routes to nearby amenities and awards points based on distance to each amenity. Walk Score® also measures pedestrian friendliness by analyzing population density and road metrics such a block length and intersection density. Scores are given on a scale of 0 to 100.
Measure: Neighborhood walkability using Walk Score® Time: Baseline
Description: MedGem® is an FDA cleared and validated indirect calorimetry device. It is handheld and measures oxygen consumption (V02) to determine resting metabolic rate (RMR).
Measure: Resting Metabolic Rate Time: Baseline
Description: The BRFSS is a state-based system of health surveys that collects information on health risk behaviors, preventative health practices, and health care access primarily related to chronic disease and injury. The GLB-TBI uses the two subscales of Healthy Eating and Physical Activity from the 2017 version of the BRFSS. It consists of 14 items.
Measure: Behavioral Risk Factor Surveillance Time: Baseline, 3, 6, 12 months
Description: Quality of life will be assess using the stroke impact scale (SIS), which assesses 8 dimensions of health-related QOL specific to people post CVA including subscales (using a 5pt Likert scale) assessing strength, memory and thinking, emotion, communication, activities of daily living, mobility, hand function, and participation/role function
Measure: Participant quality of ife Time: Baseline, 6, 12 months
Description: This inventory consists of 40 life events and asks the participant to recall if any of the events happened within the previous year (e.g., death of spouse; personal illness; change in sleep). Endorsement of these events are totaled and higher scores indicate a greater amount of stressful life events. Point values for the Holmes and Rahe Stress Inventory were weighted and summed for each individual based on scoring instructions. Individuals who scored 150 points or less were categorized as low susceptibility to a health breakdown in the next two years, 151-300 points were 50% chance of health breakdown, and 301 points or more were 80% chance of health breakdown.
Measure: Stressful Life Events using the Holmes and Rahe Stress Inventory Time: Baseline and 12 months
Description: The MOCA is a brief, 8-section assessment of various cognitive domains including executive function, memory, language, attention, concentration, orientation, and working memory in neurologic populations.Each item on the MOCA is allocated a set of points adding up to 30.
Measure: Executive Function and Cognition using the Montreal Cognitive Assessment Time: Baseline, 3, and 12 months
Description: The self-reported habit index (SRHI) measures the self-reported perceptions of habit strength for an identified behavior. It consists of 12 items for each selected behavior and uses a 7-point Likert scale from "completely disagree" to "completely agree." Higher totals represent greater perception of habit strength. The SRHI showed high reliability across four studies with alphas of .89, .92, .89, .94, .95, .94, and .85.
Measure: Habit Formation Time: Baseline, 3, and 12 months
Description: The Modified Rankin Scale (MRS) measures the degree of disability or dependence for daily activities of people who have had a stroke. The MRS is an ordinal scale with six categories ranging from zero (no symptoms) to five (complete physical dependence). A score of six signifies death.
Measure: Stroke Severity Time: Baseline
Description: The Pain Interference-Short Form is taken from the Patient-Reported Outcomes Measurement Information System (PROMIS). This measure is used to assess adult self-reported consequences of pain and pain consequences (e.g. interference in social, cognitive, emotional, physical and recreational activities). This measure consists of four questions with five response option ranging from one to five. The sum of all responses creates a total raw score. This measure is normed to the US general population.
Measure: Pain Interference Time: Baseline, 3, 6, and 12 months
Description: The Sleep Disturbance-Short Form 4a is taken from the Patient-Reported Outcomes Measurement Information System (PROMIS) and used to assess adult sleep disturbance profiles. This measure has four questions, each with five response options ranging in value from one to five. The sum of each response creates a total raw score. The measure is normed to the US general population.
Measure: Sleep Disturbance Time: Baseline, 3, 6, 12 months
Description: Waist circumference will be measured at the umbilicus following ACSM guidelines. A total of three measurements will be taken and an average of the three will be the final measurement used. Measurements will be scored in centimeters.
Measure: Waist Circumference Time: Baseline, 3, 6, and 12 months
Description: Fasting venous sample will be obtained for hemoglobin a1c to assess average blood sugar level over the past 2-3 months. Coordinators are trained phlebotomists.
Measure: HbA1c Time: Baseline, 3, 6, and 12 months
Description: Fasting venous sample will be obtained. Coordinators are trained phlebotomists.
Measure: Triglycerides Time: Baseline, 3, 6, 12 months
Description: Fasting venous sample will be obtained. Coordinators are trained phlebotomists.
Measure: Blood Glucose Time: Baseline, 3, 6, 12 months
Description: Isrin, Angiogenic factors (VEGF), Total Homocysteine, Lipoprotein-associated phospholipase A2 (Lp-PLA2), ICF-1, Brain derived neurotrophic factor (BDNF), and Tau proteins (total and phosphorylated) will be drawn to assess relationships with outcome variables.
Measure: Biomarker Analysis Time: Baseline, 3, and 6 months
Description: A modified version of Prochaska and DiClemente's Stages of Change model will be administered to measure readiness for behavior change. The measure consists of two behaviors (eating and exercise) with five questions each related to a stage of change (precontemplation, contemplation, preparation, action, maintenance).
Measure: Stages of Change Time: Baseline, 3, 6, and 12 months
Description: The metabolic score calculator will be used at all time points to determine the risk for metabolic syndrome. The following variables will be used to determine metabolic risk using the free metabolic risk calculator: gender, race and ethnicity, systolic blood pressure, fasting glucose, triglycerides, high-density lipoprotein (HDL), weight, height, and waist circumference. Scores are calculated are standardized to the general population.
Measure: Metabolic Score Calculator (MetS) Time: Baseline, 3, 6, and 12 months
Description: This self-report survey was developed by the National Institute of Mental Health. The full survey consists of 64 questions with an open-ended section at the end to elicit concerns and feedback related to the effects of COVID-19. For this current study, however, only sections on Exposure Status (10 items), Life Changes (15 items), and Emotions/Worries (7 items), and the open-ended question will be asked. Questions are asked "over the past two weeks."
Measure: CRISIS (CoRonavIruS Health Impact Survey) V0.3 Adult Baseline Form Time: Up to 12 months
Description: The Social Isolation Short-Form 4a is taken from the Patient-Reported Outcomes Measurement Information System (PROMIS). This form assesses the perceptions of being "avoided, excluded, detached, disconnected from, or unknown by, others. There is no timeframe for the form. The measure is normed to the US population.
Measure: PROMIS Social Isolation Short Form 4a Time: Up to 12 months
Description: To assess media exposure and fear of media exposure during COVID-19 we have added 6 questions. These are asked "over the past two weeks." These questions address time spent watching the television, listening to radio, reading the newspaper, and searching the internet and social media. In addition, a 6th question related to fear is asked using a 5-point Likert scale.
Measure: Media Questionnaire Time: Up to 12 months
3 A Prospective, Randomized, Factorial Design, Interventional Study to Compare the Safety and Efficacy of Combinations of Blockade of Interleukin-6 Pathway and Interleukin-1 Pathway to Best Standard of Care in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 Patients With Acute Hypoxic Respiratory Failure and Systemic Cytokine Release Syndrome
Primary Outcomes
Description: Will be obtained using the same scale over the study period that is accessible to people with and without a mobility device (e.g., walker; wheelchair).
Measure: Change in weight Time: Baseline, 3, 6, 12 monthsSecondary Outcomes
Description: Accelerometers will be worn by participants for two weeks around each study visit to objectively track physical activity participation (amount and intensity). Participants will be given the Actigraph accelerometer at the beginning of the study and will be provided with verbal and written instructions.
Measure: Physical Activity Time: Baseline, 3, 6, 12 monthsDescription: Arm circumference measured at mid-upper arm following ACSM guidelines. A total of three measurements will be taken and an average of the three will be used. Measurements will be taken in centimeters.
Measure: Arm Circumference Time: Baseline, 3, 6, 12 monthsDescription: Using an automatic cuff (average of three readings, patient seated) diastolic and systolic scores will be recorded
Measure: Blood Pressure Time: Baseline, 3, 6, 12 monthsDescription: Fasting venous sample will be obtained. Coordinators are trained phlebotomists.
Measure: Cholesterol Time: Baseline, 3, 6, 12 monthsDescription: The Framingham Heart Study diabetes risk score will be calculated using predictors including age, gender, fasting glucose, BMI, HDL cholesterol and triglyceride levels, blood pressure, and parental history. Risk score calculator and regression model are free and used in GLB weight-loss trials. Risk score calculator and regression model are free and used in GLB weight-loss studies. Each risk predictor is assigned points ranging from 2-10. Risk factors are combined and a total score is calculated, with higher scores designating greater 8-year risk.The age range for this score is 45 years to 64 years, and therefore only individuals within this age will have calculated scores. Furthermore, the minimum cut-off score is 3.
Measure: Risk of Diabetes Time: Baseline, 3, 6, 12 monthsDescription: Assesses walking speed in (m/s) which is correlated to mobility in the community, capacity to perform ADLs, risk of falls, re-hospitalization, and risk of cognitive decline.
Measure: 10 Meter Walk Test (10MWT) Time: Baseline, 3, 6, 12 monthsDescription: Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity. Endurance is essential to participate in community-based activities.
Measure: 6 Minute Walk Test (6MWT) Time: Baseline, 3, 6, 12 monthsDescription: The Multidimensional Scale of Perceived Social Support (MSPSS) is comprised of 12 questions with a 4-item subscale. The MSPSS is designed to assess perception of social support from friends, family, and significant others
Measure: Perceived Social Support Time: Baseline and 12 monthsDescription: Measure includes 28 items that assess health practices among people with disabilities and yields a total Health Practices score plus 4 subscales scores regarding Exercise, Nutrition, Health Practices, and Psychological Well Being. Items are rated on a 5-point scale from 0 'not at all' to 4 'completely.' Scores range from 0-28 with higher scores indicating higher exercise self-efficacy.
Measure: Self-reported activities of health using the Self-Rated Abilities for Health Practice scale Time: Baseline and 12 monthsDescription: Walk Score® is publicly available and measures the walkability of any address using a patented system. For each address, Walk Score ® analyzes hundreds of walking routes to nearby amenities and awards points based on distance to each amenity. Walk Score® also measures pedestrian friendliness by analyzing population density and road metrics such a block length and intersection density. Scores are given on a scale of 0 to 100.
Measure: Neighborhood walkability using Walk Score® Time: BaselineDescription: MedGem® is an FDA cleared and validated indirect calorimetry device. It is handheld and measures oxygen consumption (V02) to determine resting metabolic rate (RMR).
Measure: Resting Metabolic Rate Time: BaselineDescription: The BRFSS is a state-based system of health surveys that collects information on health risk behaviors, preventative health practices, and health care access primarily related to chronic disease and injury. The GLB-TBI uses the two subscales of Healthy Eating and Physical Activity from the 2017 version of the BRFSS. It consists of 14 items.
Measure: Behavioral Risk Factor Surveillance Time: Baseline, 3, 6, 12 monthsDescription: Quality of life will be assess using the stroke impact scale (SIS), which assesses 8 dimensions of health-related QOL specific to people post CVA including subscales (using a 5pt Likert scale) assessing strength, memory and thinking, emotion, communication, activities of daily living, mobility, hand function, and participation/role function
Measure: Participant quality of ife Time: Baseline, 6, 12 monthsDescription: This inventory consists of 40 life events and asks the participant to recall if any of the events happened within the previous year (e.g., death of spouse; personal illness; change in sleep). Endorsement of these events are totaled and higher scores indicate a greater amount of stressful life events. Point values for the Holmes and Rahe Stress Inventory were weighted and summed for each individual based on scoring instructions. Individuals who scored 150 points or less were categorized as low susceptibility to a health breakdown in the next two years, 151-300 points were 50% chance of health breakdown, and 301 points or more were 80% chance of health breakdown.
Measure: Stressful Life Events using the Holmes and Rahe Stress Inventory Time: Baseline and 12 monthsDescription: The MOCA is a brief, 8-section assessment of various cognitive domains including executive function, memory, language, attention, concentration, orientation, and working memory in neurologic populations.Each item on the MOCA is allocated a set of points adding up to 30.
Measure: Executive Function and Cognition using the Montreal Cognitive Assessment Time: Baseline, 3, and 12 monthsDescription: The self-reported habit index (SRHI) measures the self-reported perceptions of habit strength for an identified behavior. It consists of 12 items for each selected behavior and uses a 7-point Likert scale from "completely disagree" to "completely agree." Higher totals represent greater perception of habit strength. The SRHI showed high reliability across four studies with alphas of .89, .92, .89, .94, .95, .94, and .85.
Measure: Habit Formation Time: Baseline, 3, and 12 monthsDescription: The Modified Rankin Scale (MRS) measures the degree of disability or dependence for daily activities of people who have had a stroke. The MRS is an ordinal scale with six categories ranging from zero (no symptoms) to five (complete physical dependence). A score of six signifies death.
Measure: Stroke Severity Time: BaselineDescription: The Pain Interference-Short Form is taken from the Patient-Reported Outcomes Measurement Information System (PROMIS). This measure is used to assess adult self-reported consequences of pain and pain consequences (e.g. interference in social, cognitive, emotional, physical and recreational activities). This measure consists of four questions with five response option ranging from one to five. The sum of all responses creates a total raw score. This measure is normed to the US general population.
Measure: Pain Interference Time: Baseline, 3, 6, and 12 monthsDescription: The Sleep Disturbance-Short Form 4a is taken from the Patient-Reported Outcomes Measurement Information System (PROMIS) and used to assess adult sleep disturbance profiles. This measure has four questions, each with five response options ranging in value from one to five. The sum of each response creates a total raw score. The measure is normed to the US general population.
Measure: Sleep Disturbance Time: Baseline, 3, 6, 12 monthsDescription: Waist circumference will be measured at the umbilicus following ACSM guidelines. A total of three measurements will be taken and an average of the three will be the final measurement used. Measurements will be scored in centimeters.
Measure: Waist Circumference Time: Baseline, 3, 6, and 12 monthsDescription: Fasting venous sample will be obtained for hemoglobin a1c to assess average blood sugar level over the past 2-3 months. Coordinators are trained phlebotomists.
Measure: HbA1c Time: Baseline, 3, 6, and 12 monthsDescription: Fasting venous sample will be obtained. Coordinators are trained phlebotomists.
Measure: Triglycerides Time: Baseline, 3, 6, 12 monthsDescription: Fasting venous sample will be obtained. Coordinators are trained phlebotomists.
Measure: Blood Glucose Time: Baseline, 3, 6, 12 monthsDescription: Isrin, Angiogenic factors (VEGF), Total Homocysteine, Lipoprotein-associated phospholipase A2 (Lp-PLA2), ICF-1, Brain derived neurotrophic factor (BDNF), and Tau proteins (total and phosphorylated) will be drawn to assess relationships with outcome variables.
Measure: Biomarker Analysis Time: Baseline, 3, and 6 monthsDescription: A modified version of Prochaska and DiClemente's Stages of Change model will be administered to measure readiness for behavior change. The measure consists of two behaviors (eating and exercise) with five questions each related to a stage of change (precontemplation, contemplation, preparation, action, maintenance).
Measure: Stages of Change Time: Baseline, 3, 6, and 12 monthsDescription: The metabolic score calculator will be used at all time points to determine the risk for metabolic syndrome. The following variables will be used to determine metabolic risk using the free metabolic risk calculator: gender, race and ethnicity, systolic blood pressure, fasting glucose, triglycerides, high-density lipoprotein (HDL), weight, height, and waist circumference. Scores are calculated are standardized to the general population.
Measure: Metabolic Score Calculator (MetS) Time: Baseline, 3, 6, and 12 monthsDescription: This self-report survey was developed by the National Institute of Mental Health. The full survey consists of 64 questions with an open-ended section at the end to elicit concerns and feedback related to the effects of COVID-19. For this current study, however, only sections on Exposure Status (10 items), Life Changes (15 items), and Emotions/Worries (7 items), and the open-ended question will be asked. Questions are asked "over the past two weeks."
Measure: CRISIS (CoRonavIruS Health Impact Survey) V0.3 Adult Baseline Form Time: Up to 12 monthsDescription: The Social Isolation Short-Form 4a is taken from the Patient-Reported Outcomes Measurement Information System (PROMIS). This form assesses the perceptions of being "avoided, excluded, detached, disconnected from, or unknown by, others. There is no timeframe for the form. The measure is normed to the US population.
Measure: PROMIS Social Isolation Short Form 4a Time: Up to 12 monthsDescription: To assess media exposure and fear of media exposure during COVID-19 we have added 6 questions. These are asked "over the past two weeks." These questions address time spent watching the television, listening to radio, reading the newspaper, and searching the internet and social media. In addition, a 6th question related to fear is asked using a 5-point Likert scale.
Measure: Media Questionnaire Time: Up to 12 monthsThe purpose of this study is to test the safety and effectiveness of individually or simultaneously blocking IL-6 and IL-1 versus standard of care on blood oxygenation and systemic cytokine release syndrome in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine release syndrome
NCT04330638 COVID-19 Other: Usual Care Drug: Anakinra Drug: Siltuximab Drug: Tocilizumab
Primary Outcomes
Description: defined as the time from randomization to either an improvement of two points on a six-category ordinal scale or discharge from the hospital: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized
Measure: Time to Clinical Improvement Time: at day 15Secondary Outcomes
Description: defined as independece from supplemental oxygen
Measure: Time to improvement in oxygenation Time: during hospital admission (up to 28 days)Description: defined by Pa02/FiO2 ratio while breading room air
Measure: Mean change in oxygenation Time: day 1, day 15 or hospital discharge, whichever is firstMeasure: Number of days with hypoxia Time: during hospital admission (up to 28 days)
Measure: Number of days of supplemental oxygen use Time: during hospital admission (up to 28 days)
Measure: Time to absence fever for more than 48h without antipyretics Time: during hospital admission (up to 28 days)
Measure: Number of days with fever Time: during hospital admission (up to 28 days)
Measure: Time to halving of CRP levels compared to peak value during trial Time: during hospital admission (up to 28 days)
Measure: Time to halving of ferritin levels compared to peak value during trial Time: during hospital admission (up to 28 days)
Measure: Incidence of AEs (Adverse Events) Time: during hospital admission (up to 28 days)
Measure: Incidence of SAEs (Serious Adverse Events) Time: during hospital admission (up to 28 days)
Measure: Duration of hospital stay Time: during hospital admission (up to 28 days)
Measure: Duration of hospital stay in survivors Time: during hospital admission (up to 28 days)
Description: SOFA score: 0 (best) - 24 (worse)
Measure: Mean change of SOFA score (Sequential Organ Failure Assessment) between day 1 and day 7 Time: Day 1, day 7or hospital discharge, whichever is firstDescription: SOFA score: 0 (best) - 24 (worse)
Measure: Mean change of SOFA score between day 1 and day 15 Time: day 1, day 15 or hospital discharge, whichever is firstDescription: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized
Measure: Percentage of patients reporting each severity rating on a 6-point ordinal scale in relation to serum IL-1 Time: at day 15 or hospital discharge, whichever is firstDescription: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized
Measure: Percentage of patients reporting each severity rating on a 6-point ordinal scale in relation to serum IL-6 Time: at day 15 or hospital discharge, whichever is firstMeasure: Incidence of nosocomial bacterial or invasive fungal infection Time: during hospital admission (up to 28 days)
Description: defined by Hs (Hemophagocytic Syndrome) score
Measure: incidence of secondary haemophagocytic lymphohistiocytosis Time: during hospital admission (up to 28 days)Description: defined by Hs score
Measure: Incidence of secondary haemophagocytic lymphohistiocytosisscore in relation to serum IL-1 Time: during hospital admission (up to 28 days)Description: defined by Hs score
Measure: Incidence of secondary haemophagocytic lymphohistiocytosis in relation to serum IL-6 Time: during hospital admission (up to 28 days)Measure: Time to first use of high-flow oxygen devices, non-invasive or invasive mechanical ventilation in non-ventilated patients Time: during hospital admission (up to 28 days)
Measure: Time to first use of salvage systemic steroids in ventilated patients Time: during hospital admission (up to 28 days)
Measure: Number of ventilator free days Time: during hospital admission (up to 28 days)
Measure: Duration of mechanical ventilation in ventilated patients Time: during hospital admission (up to 28 days)
Measure: Duration of ICU stay in patients that enrolled in trial while already on invasive or non-invasive mechanical ventilation Time: during hospital admission (up to 28 days)
Measure: Time to progression to ARDS in ventilated patients, according to the adapted Berlin criteria Time: during hospital admission (up to 28 days)
Measure: Time to progression to ARDS in ventilated patients according to IL-1 Time: during hospital admission (up to 28 days)
Measure: Time to progression to ARDS in ventilated patients according to IL-6 Time: during hospital admission (up to 28 days)
Measure: All-cause mortality rate (excluding group that entered during ventilation) Time: during hospital admission (up to 28 days)
Measure: Percentage of patients in clinical status on 6-point Ordinal Scale Time: at 10-20 weeks follow-up
Measure: Incidence of lung function abnormalities Time: at 10-20 weeks follow-up
Measure: Incidence of lung fibrosis on chest CT scan Time: at 10-20 weeks follow-up
Measure: All-cause mortality rate Time: at 10-20 weeks follow-up
4 Ayurveda for Flu-like Illness During the Covid 19 Outbreak: Non Randomised Single-blind Controlled Trial
This study aimed to evaluate the efficacy and safety of Ayurveda in reducing symptoms of flu like illness during the Covid 19 outbreak.
NCT04351542 Flu Like Illness Dietary Supplement: Ayurveda Other: Usual Care
Primary Outcomes
Description: Time to bring down a fever (oral temperature < 37.2 ̊C)
Measure: Time to achieve afebrile Time: Change from baseline to 3rd and 7th-dayDescription: Symptoms diary card completed twice daily from Day 0 to Day 7
Measure: Severity of symptom score Time: Change from baseline to 3rd and 7th daySecondary Outcomes
Description: Patient reported improvement using 4 scale; 0-none, 1-weak, 2-medium, 3-strong
Measure: Patient reported improvement Time: Change from baseline to 3rd and 7th-day5 Pragmatic Trial Exploring Impact of Patient Positioning in the Management of Patients Infected With COVID-19: Supine vs. Prone
This study aims to determine if provider-recommended guidance on supine (on back) vs. prone (on stomach) positioning of patients testing positive for COVID-19 requiring supplemental oxygen, but not yet mechanically ventilated, improves outcomes in the inpatient setting. This study will be performed as a pragmatic clinical trial.
NCT04359797 COVID-19 Other: Prone Other: Usual Care
Primary Outcomes
Description: The highest level of support on the 5th day after enrollment according to the following scale adjusted for patient status at enrollment according to the same scale and ranked by mean FIO2 within each category, as appropriate. Death ECMO Mechanical ventilation (ranked by mean FIO2) Non-invasive ventilation such as BiPAP (ranked by mean FIO2) High flow nasal cannula, e.g. Optiflow, Vapotherm or other similar device (titrated by FiO2%) (ranked by mean FIO2) Standard nasal cannula (titrated by L/min up to 15 L/min) or face mask (ranked by mean FIO2) Room air
Measure: Modified WHO Ordinal Scale Time: 5 days post-randomizationSecondary Outcomes
Description: For each day, the investigators will record the most intensive oxygen delivery mode and then, for that highest level of oxygen support device, the max FiO2 while exposed to that device.
Measure: FIO2 Time: First 5 days post-randomization6 COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19 (the COMBAT-COVID-19 Pilot Study)
The most prevalent complication of COVID-19 infection is respiratory failure from severe acute respiratory syndrome (SARS), the leading cause of mortality. There is increasing indication that the decompensation in severe COVD-19 infection may be due to a cytokine storm syndrome. This hyperinflammatory syndrome results in a fulminant and fatal hypercytokinemia and multiorgan failure. Approximately 15% of patients with COVID-19 infection are hospitalized and 20-30% of these hospitalized patients require ICU care and/or mechanical ventilation. Overall mortality in hospitalized patients is approximately 20-25%. There is significant interest in therapies that can be given upstream to reduce the rate of mechanical ventilation and thus mortality. We hypothesize that treatment with colchicine in COVID-19 moderate-severe patients may decrease the risk of progression into ARDS requiring increased oxygen requirements, mechanical ventilation, and mortality.
NCT04363437 Coronavirus Infection Drug: Colchicine Drug: Usual Care MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Measure: Percentage of Patients requiring supplemental oxygen beyond 8L nasal cannula Time: through study completion, estimated 2 monthsSecondary Outcomes
Measure: Percentage of patients who will require mechanical ventillation Time: through study completion, estimated 2 monthsMeasure: Hospital length of stay Time: through study completion, estimated 2 months
Measure: Mortality Time: through study completion, estimated 2 months
Measure: Maximum CRP Time: through study completion, estimated 2 months
Measure: Maximum troponin elevation Time: through study completion, estimated 2 months
7 Adapting the US-based Clinic-community Model of Child Obesity Treatment Into an Online Intervention Model in Singapore During COVID-19
Background: The Coronavirus 2019 (COVID-19) is an infectious disease, which was first identified in December 2019 and has then spread rapidly around the world. COVID-19 spreads mainly through respiratory droplets and causes people to experience mild to moderate respiratory illness. On 11 March 2020, the World Health Organisation (WHO) declared COVID-19 a pandemic. With the surge in cases and to contain the spread of this disease, Singapore implemented a circuit breaker to reduce movements and interactions in public and private places. People are advised to stay at home and practise social distancing. With restrictions in movements, parents and children are likely to be more sedentary in this pandemic. There is an urgent need to move face-to-face interventions to online interventions as it is important to be active in this period. Childhood obesity threatens the health of US and Singapore populations. In the US, 30% of children are overweight, 17% have obesity, and 8% have severe obesity. In Singapore, 13% of children have obesity, and approximately half of all overweight children live in Asia. In both countries the prevalence is increasing, especially amongst the lower income populations, and is associated with future cardiovascular and metabolic disease. In US, obesity is most prevalent in Black and Hispanic populations and in Singapore, obesity affects Malays and Indians disproportionately. The underlying drivers and potential solutions thus share many common factors. The current evidence shows a clear dose-response effect with increasing number of hours of treatment, with a threshold for effectiveness at > 25 hours over a 6-month period. A key gap in delivering this recommendation is meeting the intensity, and delivering comprehensive treatment that is culturally relevant, engaging to families, and integrated within the community context. The study is an online pilot randomised controlled trial among children aged 4-6 with obesity, in Singapore, to test a novel school-clinic-community online intervention, the KK Hospital (KKH) Sports Singapore program, for child obesity treatment with usual care. The primary outcome is intensity of treatment as measured by hours of exposure to intervention. The online KKH Sports Singapore program involves 3-4 weekly online sessions of physical activity and nutrition lessons for children and parents.
NCT04395430 Pediatric Obesity Clinical Trial Behavioral: Usual Care Behavioral: online KKH Sports Singapore Program with Usual Care MeSH:Obesity Pediatric Obesity
HPO:Obesity
Primary Outcomes
Description: Measure intensity of intervention from baseline to 6 months. Intensity is measured using the number of hours of exposure to intervention.
Measure: Intensity of intervention Time: 6 months
Secondary Outcomes
Description: Measure change in cardiorespiratory fitness at baseline, 3 months and 6 months using the 3 minute step test.
Measure: Change in cardiorespiratory fitness Time: Baseline, 3 months and 6 months
Description: Measure change in quality of life at baseline, 3 months and 6 months using the Paediatric Quality of Life Inventory (PedsQL; US version 4). PedsQL is a comprehensive and multi-dimensional construct that includes physical, emotional, and social functioning to assess quality of life in the children. It uses a 5-point Likert scale where 0= never, 1 = almost never, 2 = sometimes, 3 = often, 4 = almost always. Items will be reverse scored and linearly transformed to a 0-100 scale so that higher scores indicate better quality of life.
Measure: Change in quality of life Time: Baseline, 3 months and 6 months
Description: Measure the stabilisation or change in BMI at baseline, 3 months and 6 months. Body mass index (BMI) will be calculated as kg/m2.
Measure: Change in BMI Time: Baseline, 3 months and 6 months
Description: Measure change in self-esteem at baseline, 3 months and 6 months. Self-esteem is measured using the Behavioural Rating Scale of Presented Self-Esteem questionnaire. The first category of items consists of active displays of confidence, curiosity, initiative, exploration and independence while the second category consists of adaptive reactions to change or stress. It uses a four-point scale from 1-4 where higher scores indicate higher self-esteem.
Measure: Change in self-esteem Time: Baseline, 3 months and 6 months
Description: Measure change in eating behaviour at baseline, 3 months and 6 months. Eating behaviour is measured using the Child Eating Behaviour Questionnaire (CEBQ). The questionnaire consists of 35 items and measures food responsiveness, emotional over-eating, enjoyment of food, desire to drink, satiety responsiveness, slowness in eating, emotional under-eating and food fussiness using a 5-point Likert scale (1= never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always). Higher scores indicate higher level of behaviour in the respective dimensions.
Measure: Change in eating behaviour Time: Baseline, 3 months and 6 months
Description: Measure change in gross motor skills at baseline, 3 months and 6 months. Gross motor skills is measured using the Test of Gross Motor Development (Ver. 3.0). The first subtest, Locomotor, measures the gross motor skills that require fluid coordinated movements of the body as the child moves in one direction or another. The second subtest, Ball Skills, measure the gross motor skills that demonstrate efficient throwing, striking, and catching movements.
Measure: Change in gross motor skills Time: Baseline, 3 months and 6 months
Description: Measure change in caloric intake using a three day food diary at baseline, 3 months and 6 months.
Measure: Change in caloric intake Time: Baseline, 3 months and 6 months
Description: Measure change in physical activity using results from accelerometer to assess time spent on sedentary and moderate to vigorous physical activity at baseline, 3 months and 6 months.
Measure: Change in physical activity Time: Baseline, 3 months and 6 months
Description: Measure change in blood pressure at baseline, 3 months and 6 months. Blood pressure will be measured in mmHg via an electronic sphygmomanometer. Both systolic and diastolic blood pressure will be measured.
Measure: Change in blood pressure Time: Baseline, 3 months and 6 months
Description: Measure change in waist circumference at baseline, 3 months and 6 months. Waist circumference is measured at the narrowest point between the lower costal (rib) border and the iliac crest using a non-extensible steel tape.
Measure: Change in waist circumference Time: Baseline, 3 months and 6 months
Description: Measure change in number of servings of fruits and vegetables using a three day food diary at baseline, 3 months and 6 months .
Measure: Change in servings of fruits and vegetables Time: Baseline, 3 months and 6 months
8 Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Angiotensin II Type 1 Receptor Blockers (ARBs) on Outcomes of Coronavirus Infection?
Primary Outcomes
Description: Measure intensity of intervention from baseline to 6 months. Intensity is measured using the number of hours of exposure to intervention.
Measure: Intensity of intervention Time: 6 monthsSecondary Outcomes
Description: Measure change in cardiorespiratory fitness at baseline, 3 months and 6 months using the 3 minute step test.
Measure: Change in cardiorespiratory fitness Time: Baseline, 3 months and 6 monthsDescription: Measure change in quality of life at baseline, 3 months and 6 months using the Paediatric Quality of Life Inventory (PedsQL; US version 4). PedsQL is a comprehensive and multi-dimensional construct that includes physical, emotional, and social functioning to assess quality of life in the children. It uses a 5-point Likert scale where 0= never, 1 = almost never, 2 = sometimes, 3 = often, 4 = almost always. Items will be reverse scored and linearly transformed to a 0-100 scale so that higher scores indicate better quality of life.
Measure: Change in quality of life Time: Baseline, 3 months and 6 monthsDescription: Measure the stabilisation or change in BMI at baseline, 3 months and 6 months. Body mass index (BMI) will be calculated as kg/m2.
Measure: Change in BMI Time: Baseline, 3 months and 6 monthsDescription: Measure change in self-esteem at baseline, 3 months and 6 months. Self-esteem is measured using the Behavioural Rating Scale of Presented Self-Esteem questionnaire. The first category of items consists of active displays of confidence, curiosity, initiative, exploration and independence while the second category consists of adaptive reactions to change or stress. It uses a four-point scale from 1-4 where higher scores indicate higher self-esteem.
Measure: Change in self-esteem Time: Baseline, 3 months and 6 monthsDescription: Measure change in eating behaviour at baseline, 3 months and 6 months. Eating behaviour is measured using the Child Eating Behaviour Questionnaire (CEBQ). The questionnaire consists of 35 items and measures food responsiveness, emotional over-eating, enjoyment of food, desire to drink, satiety responsiveness, slowness in eating, emotional under-eating and food fussiness using a 5-point Likert scale (1= never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always). Higher scores indicate higher level of behaviour in the respective dimensions.
Measure: Change in eating behaviour Time: Baseline, 3 months and 6 monthsDescription: Measure change in gross motor skills at baseline, 3 months and 6 months. Gross motor skills is measured using the Test of Gross Motor Development (Ver. 3.0). The first subtest, Locomotor, measures the gross motor skills that require fluid coordinated movements of the body as the child moves in one direction or another. The second subtest, Ball Skills, measure the gross motor skills that demonstrate efficient throwing, striking, and catching movements.
Measure: Change in gross motor skills Time: Baseline, 3 months and 6 monthsDescription: Measure change in caloric intake using a three day food diary at baseline, 3 months and 6 months.
Measure: Change in caloric intake Time: Baseline, 3 months and 6 monthsDescription: Measure change in physical activity using results from accelerometer to assess time spent on sedentary and moderate to vigorous physical activity at baseline, 3 months and 6 months.
Measure: Change in physical activity Time: Baseline, 3 months and 6 monthsDescription: Measure change in blood pressure at baseline, 3 months and 6 months. Blood pressure will be measured in mmHg via an electronic sphygmomanometer. Both systolic and diastolic blood pressure will be measured.
Measure: Change in blood pressure Time: Baseline, 3 months and 6 monthsDescription: Measure change in waist circumference at baseline, 3 months and 6 months. Waist circumference is measured at the narrowest point between the lower costal (rib) border and the iliac crest using a non-extensible steel tape.
Measure: Change in waist circumference Time: Baseline, 3 months and 6 monthsDescription: Measure change in number of servings of fruits and vegetables using a three day food diary at baseline, 3 months and 6 months .
Measure: Change in servings of fruits and vegetables Time: Baseline, 3 months and 6 monthsThe coronavirus (COVID-19) pandemic continues to grow exponentially. Angiotensin II levels are increased in human influenza and are associated with influenza viral load, disease progression and mortality. Preliminary data shows angiotensin II receptor blockers (ARBs) limits lung injury in murine influenza H7N9, as well as viral titre and RNA. ARBs could limit viral titre and organ injury in COVID-19. We will therefore collect clinical chart data and test angiotensin II levels of patients who are admitted to ICU with COVID-19 to determine whether there is a correlation between taking ARBs and clinical outcomes in these patients. Other blood biomarkers and clinical risk factors for COVID-19 have come to light in recent weeks. We include these in our observational analysis to help generate an understanding of COVID-19 presentation and blood biomarker characterization of disease.
NCT04510623 COVID-19 SARS-CoV2 Other: ARBs and/or ACE inhibitors Other: Usual Care MeSH:Coronavirus Infections
Primary Outcomes
Measure: COVID-19 WHO ordinal scale Time: 14 daysSecondary Outcomes
Measure: Organ Dysfunction Time: 14 daysMeasure: 28-day mortality Time: 29 days or less (may be discharged from critical care before day 28)
Measure: Hospital/ICU length of stay Time: 29 days or less (may be discharged before day 28)
Measure: ICU admission Time: 29 days or less (may be discharged from critical care before day 28)