Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2463 | Performance of WHEELS-I in promoting DASH/SRD adoption Wiki | 0.50 |
| drug1160 | Effects of a 2-week DASH/SRD intervention vs. control diet on HFpEF functional cardiovascular risk factors Wiki | 0.50 |
| drug2276 | Nutritional education Wiki | 0.50 |
Navigate: Correlations HPO
There are 4 clinical trials
Tens of thousands of Veterans have heart failure with preserved ejection fraction (HFpEF), and suffer poor quality of life, frequent hospitalizations, and high death rates. Older Veterans and those with high blood pressure, obesity, and the metabolic syndrome (abnormal cholesterol and resistance to insulin's effects) are particularly at risk for HFpEF. However, it is not clear why only some Veterans in this risk group eventually develop HFpEF. Extensive information from experimental animal models and some human studies suggests that dietary patterns in vulnerable 'salt-sensitive' people could contribute to the risk for HFpEF. Reducing salt intake and increasing overall dietary quality in at-risk Veterans could prevent heart and blood vessel damage that ultimately leads to HFpEF. Reducing the development of HFpEF, which currently has no definitive treatment, is highly relevant to the VA's mission to emphasize prevention of disease and population health.
Description: Velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness
Measure: Carotid-femoral pulse wave velocity Time: Phase 1 of study, change from baseline at the end of week 2 and week 4Description: Left ventricular mass indexed to height
Measure: Left ventricular mass index Time: Phase 2 of study, change from baseline to 6 monthsDescription: Ventricular stiffness k, by Parametrized Diastolic Formalism analysis
Measure: Ventricular stiffness Time: Phase 1 of study, change from baseline at the end of week 2 and week 4Description: Global longitudinal left ventricular strain, a sensitive measure of ventricular systolic function
Measure: Global longitudinal left ventricular strain Time: Phase 1 of study, change from baseline at the end of week 2 and week 4Description: Global left atrial strain, a novel measure of atrial function
Measure: Global left atrial strain Time: Phase 1 of study, change from baseline at the end of week 2 and week 4Description: Velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness
Measure: Carotid-femoral pulse wave velocity Time: Phase 2 of study, change from baseline to 6 monthsDescription: Left atrial volume by 3D echocardiography
Measure: Left atrial volume Time: Phase 2 of study, change from baseline to 6 monthsDescription: Change in 24-hour mean of >= 8 mmHg will define the salt-sensitive blood pressure phenotype
Measure: Salt-sensitivity phenotype Time: Phase 1 of study, change from baseline at the end of week 2 and week 4Description: Measure of dietary sodium intake
Measure: 24-hour urinary sodium excretion Time: Phase 2 of study, change from baseline to 6 monthsDescription: Sodium-restricted DASH diet score on Food Frequency Questionnaire, measured by complete or partial adherence to 9 dietary domains
Measure: Sodium-restricted DASH diet adherence Time: Phase 2 of study, change from baseline to 6 monthsDescription: Analysis of 3-day food diaries by a Registered Dietitian, utilizing the Nutrition Data System for Research
Measure: Sodium-restricted DASH diet adherence Time: Phase 2 of study, months 1 and 6Specific Aim #1 (Feasibility; primary aim): To assess the feasibility of the PP-MI group-based physical activity intervention and outcome assessments in patients with MetS. Hypothesis: The PP exercises and MI-based goal-setting sessions will be feasible: most (≥50%) of participants will complete 6/9 exercises/sessions. Furthermore, the investigators will be able to obtain objective physical activity measurement follow-up data from at least 80% of enrolled participants at the end of the intervention and 24 weeks later. Specific Aim #2 (Acceptability): To assess whether the intervention is acceptable to participants, as measured by ratings provided after each PP-MI session. Hypothesis: The intervention will be acceptable: participants will rate the PP-MI exercises with a mean score of at least 7 out of 10 on ease of completion and helpfulness. Specific Aim #3 (Outcomes): To assess whether this preliminary intervention appears to result in improvement of physical activity, related health behaviors (sedentary time, diet quality), psychological well-being (optimism, positive affect, anxiety, depression), and the exploratory outcomes of MetS-relevant physiological markers (e.g., blood pressure, weight, chart-reviewed lipids and HbA1C). Hypothesis a: The intervention will lead to improvements in physical activity, related health behaviors, optimism and positive affect, reductions in depression and anxiety at 9 weeks and 24 weeks compared to baseline (or the start of the intervention, for the WLC group). Hypothesis b: The hypothesis is that there will be improvements in the exploratory outcomes of the physiological markers, even if they do not reach significance.
Description: Feasibility will be measured by examining the number of completed exercises.
Measure: Feasibility of the PP-MI-Based Health Behavior Intervention Time: 8 weeks of group sessionsDescription: Participants will rate the ease and usefulness of each weekly activity (0-10).
Measure: Acceptability of Intervention Time: 8 weeksDescription: ActiGraph GT3X+ accelerometers are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer to assess the feasibility of doing so and to ensure adequate capture of physical activity.
Measure: Physical Activity Adherence (Actigraph) Time: Baseline, weeks 9, 24 (baseline, weeks 9, 17, 33 for the WLC group)Description: Feasibility will be measured by examining the rates of use of the Actigraph.
Measure: Feasibility of Actigraph Time: Baseline, weeks 9, 24 (baseline, weeks 9, 17, 33 for the WLC group)Description: The LOT-R is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 5-30)
Measure: Changes in Life Orientation Test- Revised Scores Time: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)Description: The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials, will be used to measure positive affect. (Range: 10-50)
Measure: Changes in Positive and Negative Affect Schedule Scores Time: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)Description: The HADS will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients. (Range: HADS-A, HADS-D; 0-21 each)
Measure: Changes in The Hospital Anxiety and Depression Scale Scores Time: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)Description: The BBAQ is a 21-item measure, published by the US Centers for Disease Control and Prevention (CDC), that explores seven main categories of barriers, including lack of time, energy, and resources. (Range: 0-63)
Measure: Changes in Barriers to Being Active Quiz Scores Time: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)Description: The SOM will be used to capture the changeable nature of optimism based on time and situation. (Range: 7-35)
Measure: Changes in State Optimism Measure Time: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)Description: The SF-12 will be used to measure quality of life. This instrument has been used in many patient-oriented studies. (Range: SF-12 PCS and SF-12 MCS); range 0-100 each)
Measure: Changes in The Medical Outcomes Study Short Form-12 Scores Time: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)Description: The IPAQ-SF is a validated scale that measures self-reported physical activity in the past 7 days in the domains of vigorous activity, moderate activity, and walking.
Measure: Changes in The International Physical Activity Questionnaire-Short Form Scores Time: Pre-baseline screening, weeks 9, 24 (Pre-baseline, weeks 17 and 33 for the WLC group)Description: The CDC's BRFSS Fruit and Vegetable Module is a brief questionnaire about frequency of eating different types of fruits and vegetables.
Measure: Changes in Behavioral Risk Factor Surveillance System Fruit and Vegetable Module Time: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)Description: The National Cancer Institute's Percentage Energy from Fat Screen is a brief questionnaire that estimates people's typical percentage of energy derived from eating common fat-containing foods, as fat content is related to metabolic syndrome progression.
Measure: Changes in National Cancer Institute's Percentage Energy from Fat Screener Scores Time: Baseline, weeks 9, 24 (Baseline, weeks 17 and 33 for the WLC group)A novel way of delivering nutritional education is through experiential learning in a teaching kitchen setting. Studies have shown that patients with metabolic syndrome who underwent a series of classes that featured nutrition recommendations and cooking classes had improved cardiac health. Boston Medical Center (BMC) serves many underserved, low-income patients and has developed an innovative strategy to combat food insecurity and its consequences. This includes a preventative food pantry, a teaching kitchen, and a rooftop farm that provides fresh produce directly to the patients. The presence of this well-established three-pronged approach places our institution in an ideal position to develop a nutritional education intervention that supports experiential learning in this high-risk population. Given the increasing focus on providing remote experiences to minimize contact and risk of infection with Sars-COV-2, the investigators are proposing a study where patients can benefit from nutritional education virtually. Patients with food insecurity and metabolic syndrome who utilize the food pantry will be invited to an educational program conducted on zoom. The program will be run by a registered dietician and chef who will deliver education virtually. Data will be collected using surveys, phone interviews, chart review, and home monitoring to test both the feasibility of running such an intervention virtually and to explore whether attending this program improves cardiac health in patients.
Description: based on number of people invited to participate, number recruited and consented and number attended
Measure: recruitment rates Time: 12 monthsDescription: based on attendance at each virtual educational session
Measure: retention rates Time: 12 monthsDescription: information will be obtained through qualitative interviews
Measure: facilitators for nutritional education Time: 12 monthsDescription: information will be obtained through qualitative interviews
Measure: barriers to nutritional education Time: 12 monthsDescription: through qualitative interview
Measure: knowledge of healthy foods Time: 12 monthsDescription: Baseline BP will be extracted from medical chart. Subjects will be provided with a home BP cuff. BP measurements performed by the patient will be recorded on the BP app. The 6 month follow BP will be extracted from the medical chart if available.
Measure: change in blood pressure (BP) Time: baseline, up to 6 monthsDescription: Baseline blood glucose will be extracted from medical chart. Subjects will use their own glucometer to measuture their blood glucose. glucose measurements performed by the patient will be recorded on the glucometer. The 6 month follow blood glucose will be extracted from the medical chart if available.
Measure: change in blood glucose Time: baseline, up to 6 monthsDescription: Baseline will be extracted from the chart and 6 month will be extracted from the chart if available
Measure: change in hemoglobin A1c Time: baseline, 6 monthsDescription: Baseline weight will be extracted from medical chart. Subjects will be provided with a home scale. weight measurements performed by the patient will be recorded on the scale app. The 6 month follow weight will be extracted from the medical chart if available.
Measure: change in weight Time: baseline, up to 6 monthsDPPFit is a Healthy Lifestyle Intervention designed to reformat the effective strategies of the Diabetes Prevention Program (NDPP) into a tool for use in a primary care setting. DPPFit is a 16-week technology-based intervention for diabetes prevention. In keeping with the National DPP educational sessions, the intervention weeks follow the order and presentation of the N-DPP 16 session topics. The goal is to develop a pragmatic translation of the DPP that is effective in the real-world setting of primary care clinic. The hope is that in doing so, those at risk of developing type II diabetes mellitus will have evidenced-based prevention methods at their disposal.
Description: Weight Loss by % of Body Weight Loss, by # of Participants losing 5% and 7% of Body Weight
Measure: Weight Loss Time: 12 MonthsDescription: Increase in PA days/week, Increase > 10% of PA, Kcal/week
Measure: Physical Activity Time: 6 monthsDescription: Decrease in Sedentary Time, Mins/day
Measure: Inactivity Time: 6 monthsDescription: MOS SF-20 / MOS Social Support Scale
Measure: Health Related Quality of Life Time: 6 months /Description: Reduction in % of HbA1c at 1 year follow-up
Measure: Hemoglobin A1c Time: 12 monthsAlphabetical 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