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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3495 | SPIRIT-remote Wiki | 0.50 |
| drug4518 | hypoxia : 14.3 and 12.7% FIO2, hypercapnia 7% CO2, inspiratory mechanical constraint Wiki | 0.50 |
| drug4465 | eHealth +counselling contacts Wiki | 0.50 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003704 | Dementia NIH | 0.18 |
| D003924 | Diabetes Mellitus, Type 2 NIH | 0.12 |
| D000860 | Hypoxia NIH | 0.10 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000726 | Dementia HPO | 0.18 |
| HP:0005978 | Type II diabetes mellitus HPO | 0.12 |
| HP:0012418 | Hypoxemia HPO | 0.10 |
Navigate: Correlations HPO
There are 4 clinical trials
The proposed study will adapt and pilot test an efficacious advance care planning interventions, SPIRIT (Sharing Patient's Illness Representations to Increase Trust), with patients with mild dementia and their surrogates to promote open, honest discussions while such discussions about end-of-life care are possible. The study includes two phases: Phase I to adapt, pretest, and refine SPIRIT, and Phase II to pilot test the refined SPIRIT to formally evaluate its feasibility, acceptability, and preliminary efficacy. The final products will be the modified SPIRIT intervention that improves dementia patient and surrogate outcomes, and standardized intervention manuals, including the SPIRIT Interview Guide, fidelity assessment, and training materials. Patient and surrogate decision maker dyads will participate in a single SPIRIT session and will then have a follow up phone call 2-3 days later. One year after the SPIRIT session some surrogates will be contacted to provide additional feedback about the intervention.
Description: Dyad congruence will be assessed using the Goals-of-Care Tool which has been modified to include two scenarios relevant to the context of dementia. There are three response options: "The goals of care should focus on delaying my death no matter what, and thus I want to continue life-sustaining treatment", "The goals of care should focus on my comfort and peace, and thus I do not want life-sustaining treatment", and "I am not sure". Patients and surrogates complete this tool independently and their responses are then compared to determine dyad congruence (either congruent in both scenarios or incongruent). If both members of the dyad endorse "I am not sure", they are considered incongruent.
Measure: Change in dyad congruence among Phase II participants Time: Baseline, follow up phone call (2-3 days post-intervention)Description: Surrogate decision-making confidence will be measured using the 5-item Decision Making Confidence (DMC) scale. DMC assesses a surrogate's confidence in knowing the patient's wishes, ability to make treatment decisions even in a highly stressful situation, ability to seek information about risks and benefits of medical choices, ability to handle unwanted pressure from others, and ability to communicate with providers about the patient's wishes. Surrogates indicate how confident they are about making medical decisions, if the patient becomes unable to make their own decisions, by their level of agreement with statements along a scale of (0) "not confident at all" to (4) "Very confident". Total scores range from 0 - 20, with higher scores indicating greater confidence.
Measure: Change in Surrogate's Decision Making Confidence (DMC) scale score among Phase II participants Time: Baseline, follow up phone call (2-3 days post-intervention)Description: The Overall Preparedness Scale for end-of-life decision making for surrogates is a 21-item investigator-developed measure. The measure assesses the level of preparedness for end-of-life decision making in the cognitive, emotional, and behavioral dimensions on a 4-point scale (1=strongly disagree to 4=strongly agree). Total scores range from 21 to 84, with higher scores indicating higher levels of preparedness.
Measure: Change in Surrogate's Overall Preparedness Scale Time: Baseline, follow up phone call (2-3 days post-intervention)Description: Medical records will be reviewed to determine if the patient completed an advance directive (a medical power of attorney or living will) by 12 months post-intervention. If there is no documentation, the surrogate will be contacted to get confirmation on the status of the Advance Directive.
Measure: Completion of Advance Directives among Phase I participants Time: 12 months post-interventionDescription: Medical records will be reviewed to determine if the patient completed an advance directive (a medical power of attorney or living will) by 12 months post-intervention. If there is no documentation, the surrogate will be contacted to get confirmation on the status of the Advance Directive.
Measure: Completion of Advance Directives among Phase II participants Time: 12 months post-interventionDescription: The Overall Preparedness Scale for end-of-life decision making for patients is a 20-item investigator-developed measure. The measure assesses the level of preparedness for end-of-life decision making in the cognitive, emotional, and behavioral dimensions on a 4-point scale (1=strongly disagree to 4=strongly agree). Total scores range from 20 to 80, with higher scores indicating higher levels of preparedness.
Measure: Change in Patient's Overall Preparedness Scale Time: Baseline, follow up phone call (2-3 days post-intervention)Prone positioning is a well studied and validated treatment for severe acute respiratory distress syndrome (ARDS), however there are no randomized studies on the use of prone positioning in the non-intubated patient. It is unknown if this intervention would be helpful in preventing further respiratory deterioration in terms of increasing supplemental oxygen requirements, endotracheal intubation, and ICU admission. The Awake Prone Position for Early hypoxemia in COVID-19 (APPEX-19) Study is a pragmatic adaptive randomized controlled unblinded trial. APPEX-19 randomizes non-ICU patients with COVID-19 or who are under evaluation for COVID-19 to lie in a prone position (i.e, with their stomach and chest facing down) or to usual care.
Description: Change in respiratory status will be defined as:1) admission to the ICU and/or a 2) an increase in supplemental oxygen delivery (defined as an increase in oxygen delivery rate of ≥2 liter per minute compared to the oxygen delivery rate at the time of intervention or usual care text message that is sustained for ≥12 or more hours OR the switch to an oxygen delivery method that increases the level of supplemental oxygen.
Measure: Change in respiratory status Time: up to 30 daysDescription: Length of time in the prone position will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.
Measure: Length of time participant spends in the prone position Time: up to 30 daysDescription: Length of time in the supine/lying on back position will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.
Measure: Length of time participant spends in the supine position Time: up to 30 daysDescription: Length of time lying on side will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.
Measure: Length of time participant spends lying on side Time: up to 30 daysDescription: Length of time sitting up will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.
Measure: Length of time participant spends sitting up Time: up to 30 daysDescription: Length of time standing or walking will be assessed from the smartphone survey and measured in categories of no time, up to 6 hours, 6 hours to 11 hours, 12 hours or more.
Measure: Length of time participant spends standing or walking Time: up to 30 daysDescription: Dyspnea will be assessed by the modified Borg Dyspnea Score (10-point ordinal scale) from 1= nothing at all to 10= maximal. Higher scores indicate more dyspnea.
Measure: Dyspnea or difficult/labored breathing Time: up to 30 daysDescription: Discomfort with proning (4-point ordinal scale: very comfortable, somewhat comfortable, somewhat uncomfortable, very uncomfortable)
Measure: Discomfort with proning Time: up to 30 daysDescription: Total number of days hospitalized will be abstracted from the electronic medical record.
Measure: Length of hospital stay Time: up to 30 daysDescription: Invasive mechanical ventilation will be abstracted from the electronic medical record.
Measure: Invasive mechanical ventilation Time: up to 30 daysDescription: Loss of IV access as a consequence of turning in bed will be reported by participant using monitoring surveys
Measure: Loss of IV access as a consequence of turning in bed Time: up to 30 daysDescription: ARDS diagnosis will be abstracted from the electronic medical record
Measure: Acute respiratory distress syndrome (ARDS) diagnosis Time: up to 30 daysDescription: Hospital mortality will be abstracted from the electronic medical record
Measure: Hospital mortality Time: up to 30 daysThe severe acute respiratory syndrome coronavirus 2 (SARS-CoC-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with a high incidence of acute respiratory distress syndrome (ARDS) and death. Aging, obesity, diabetes, hypertension and other risk factors associated with abnormal lipid and carbohydrate metabolism are risk factors for death in COVID-19. Recent studies suggest that COVID-19 progression is dependent on metabolic mechanisms. Moreover, gene expression analyses in cultured human bronchial cells infected with SARS-CoV-2 and lung tissue from patients with COVID-19, indicated a marked shift in cellular metabolism, with excessive intracellular lipid generation. In this cell culture system, fenofibrate (a widely available low-cost generic drug approved by the FDA and multiple other regulatory agencies around the world to treat dyslipemias) at concentrations that can be achieved clinically, markedly inhibited SARS-CoV-2 viral replication. Fenofibrate also has immunomodulatory effects that may be beneficial in the setting of COVID-19. The aim of this trial is to assess the clinical impact of fenofibrate (145 mg/d of Tricor or dose-equivalent preparations for 10 days, with dose adjustment in chronic kidney disease ([CKD]) to improve clinical outcomes in patients with COVID-19.
Description: The primary endpoint of the trial will be a global rank score that ranks patient outcomes according to 5 factors: (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) For participants enrolled as outpatients who are subsequently hospitalized, the number of days out of the hospital during the 30 day-period following randomization; (5) For participants enrolled as outpatients who don't get hospitalized during the 30-day observation period, the modified Borg dyspnea scale
Measure: Hierarchical composite endpoint Time: Up to 30 daysDescription: A seven-category ordinal scale consisting of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; and 7, death.
Measure: Seven-category ordinal scale Time: At 15 daysDescription: A global rank score similar to the primary endpoint, but using a more comprehensive COVID-19 symptom scale instead of the dyspnea Borg scale
Measure: Hierarchical composite endpoint Time: Up to 30 daysDescription: A global rank score similar to the primary endpoint, but built only with factors 1-4 of the primary endpoint
Measure: Hierarchical composite endpoint Time: Up to 30 daysThis pragmatic 3-arm randomized controlled trial is conducted within the primary health care setting. The trial evaluates the effectiveness of a personalized eHealth intervention based on a hip-worn accelerometer, smartphone application and cloud service (www.exced.com) with or without face-to-face and telephone counselling contacts on physical activity (PA) compared to usual care in increasing daily PA and reducing sedentary behavior (SB) among type 2 diabetes (T2D) patients.The duration of the intervention period is 6 months, after which there is a 6 month follow-up for evaluating the maintenance of anticipated intervention effects. The primary goal of the intervention is that the T2D patients increase their daily number of steps by replacing SB with low intensity PA. The secondary goal is to increase short bouts of moderate-to-vigorous PA according to personal goals. It is expected that the eHealth intervention complemented by individual counselling is the most effective in reaching the goals, and the eHealth intervention is more effective than usual care. Measurements are done at baseline, after the 6-month intervention, and after the 6-month follow-up. Participants' one-week PA and SB are measured with a hip-worn triaxial accelerometer and analyzed with validated algorithms. Cardiorespiratory fitness is assessed with a validated 6-minute walk test. Diabetes-related metabolic biomarkers (HbA1C, LDL-c, HDL-c, oxidized LDL and HDL lipids) and cardiovascular risk factors (blood pressure, BMI, waist circumference) are measured with standard laboratory methods. Quality of life is assessed by RAND-36 method. The interventions are evaluated with RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) method. Besides effectiveness, RE-AIM methods evaluates the target group reach and adherence; provider adoption; intervention fidelity; maintenance of the changes in PA and SB behavior, biomarkers and CVD risk factors; intervention transferability to clinical practice; adverse events; and patient and provider satisfaction. Unexpectedly, the COVID-19 pandemic in spring 2020 led to substantial restrictions in outdoors mobility of T2D patients and their access access to health care in Finland, facts that frustrated the planned implementation of the original intervention, related measurements and their scheduling. This means that not all planned measurements could be done at all or at the scheduled time point. Irrespective of the time of recruitment, all follow-up measurements are done from June to September 2020. Notwithstanding the COVID-19 pandemic annulled the original intervention, the collected data yet provides unique insights into measured physical activity, fitness and metabolic biomarkers of T2D patients before and during the COVID-19 pandemic and consequent restrictions.In addition, the data allows to evaluate the implementation of eHealth approach and face-to-face and telephone PA counselling contacts within the primary health care setting.
Description: Step count during one week is measured with a hip-worn accelerometer at baseline, 6 months, and 12 months
Measure: Change in total mean daily step count Time: At 6 and 12 months compared to baseline (0 months). N.B. Because of COVID-19, the schedule and contents of measurements may change individually depending on the time of recruitment.Description: Sedentary time and PA time at different intensity ranges are measured with a hip-worn accelerometer at baseline, 6 months and 12 months
Measure: Changes in total mean daily time of sedentary, low intensity PA and moderate-to-vigorous PA Time: at 6 and 12 months compared to baseline (0 months). N.B. Because of COVID-19, the schedule and contents of measurements may change individually depending on the time of recruitment.Description: Durations of moderate-to-vigorous PA bouts measured with a hip-worn accelerometer at baseline, 6 months and 12 months
Measure: Changes in the mean daily number of moderate-to-vigorous PA bouts lasting at least 1, 5 and 10 minutes. Time: at 6 and 12 months compared to baseline (0 months). N.B. Because of COVID-19, the schedule and contents of measurements may change individually depending on the time of recruitment.Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports