Developed by Shray Alag, The Harker School
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There is one clinical trial.
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.
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 monthsDescription: 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 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