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| ID | Type | Description | Link |
|---|---|---|---|
| 1P50MD017348-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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This study aims to determine whether a 6-month multilevel intervention involving problem-solving training, exercise training and support from community health workers is more effective in improving outcomes for individuals with low socioeconomic status, type 2 diabetes, obesity, and early cardiac dysfunction than receiving education and access to a community exercise facility.
This randomized controlled trial employs a 2:1 allocation ratio. The study aims to include 402 individuals from Baltimore City and Hagerstown, Maryland, characterized by low neighborhood and individual socioeconomic status, type 2 diabetes, obesity, and evidence of subclinical heart dysfunction, without a prior clinical diagnosis of heart failure. The 6-month multi-level intervention consists of three key components:
Problem Solving - Diabetes Self-Management Training (DECIDE): Participants will engage in a biweekly evidence-based behavioral change program known as DECIDE. This program focuses on problem-solving training, aiding individuals in managing chronic conditions by overcoming obstacles and challenges. It aims to enhance self-care, improve control of metabolic risk factors, and includes tailored education on heart failure prevention.
Community Health Worker Support: Participants will receive ongoing support from community health workers as part of the intervention. These workers will conduct telephone and/or home visits at least monthly, offering assistance in following areas:
Health Coaching and Partnership with Community Facilities: Participants will engage in supervised aerobic and resistance exercise training at the local Young Men's Christian Associations (YMCAs). The participants will receive instructions on gradually increasing the activity levels throughout the 6-month intervention to achieve physical activity goals (150 minutes of moderate to vigorous exercise per week).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community Champions | Experimental | Participants assigned to the "Community Champions" group will undergo a six-month behavioral intervention. This intervention involves bi-weekly problem-solving training sessions (DECIDE) conducted in groups of 6-10 individuals, along with support from community health workers. Additionally, participants will receive a YMCA membership to exercise with a professional health coach. |
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| Homegrown Heroes | Active Comparator | Participants assigned to the "Homegrown Heroes" will receive a YMCA membership for exercise and a monthly newsletters for 6 months that include education about diabetes self-management, healthy lifestyle and heart failure prevention . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Champions | Behavioral | The UNLOAD-Heart Failure Program intervention includes problem solving training, community health worker support, and exercise support from health coaches at YMCAs. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fitness as assessed by the 6 minute walk test | Total distance walked in the 6 minutes walk test in meters | Baseline and 6 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiac biomarker, high-sensitivity cardiac troponin-T (hs-cTnT) | Percent change from baseline in hs-cTnT | Baseline and 6 month follow up |
| Change in hemoglobin A1c | Absolute change from baseline in hemoglobin A1c |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiadi Ndumele, MD, PhD | Contact | 4105022319 | cndumel2@jhmi.edu | |
| Perri Carroll, MPH | Contact | 4436927272 | pcarro13@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chiadi Ndumele, MD, PhD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Center for Health Equity | Recruiting | Baltimore | Maryland | 21205 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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The design of the study is a randomized 2:1 parallel-arm clinical trial.
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Participants and interventionists will be unblinded, while those assessing outcomes will be blinded to the randomization arm .
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| Homegrown Heroes | Behavioral | Monthly newsletters/videos on diabetes self-management, healthy lifestyle and heart failure prevention will be provided, as well as a membership to the local YMCA. |
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| Baseline and 6 month follow up |
| Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales. | The following Health Problem-Solving Scale (HPSS) subscales will be assessed: Impulsive/Careless Problem Solving (IPS), Avoidant Problem Solving (APS), Negative Transfer (NTR), Negative Motivation/Orientation (NMO). Subscale scores are calculated by summing the scores for each item within the respective subscales. Higher subscale scores indicate more of that problem-solving characteristic. The score range for each subscale is as follows: IPS (0-32), APS (0-28), NTR (0-44), NMO (0-20). Total score range 0-124. | Baseline, 6 month follow up, 12 month follow up |
| Changes in self care measures as assessed by Summary of Diabetes Self-Care Activities Scale (SDSCA) | The Summary of Diabetes Self-Care Activities Scale (SDSCA) is a tool used to measure diabetes self-care activities. 12-items with 5 sub-scales (diet, exercise, home blood glucose testing, foot care, smoking status). The respondent is asked how many days in the past week the behavior was performed (ranges from 0 to 7); The result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior. | Baseline, 6 month follow up, 12 month follow up |
| Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test | The Diabetes and CVD Knowledge Test comprises 16 items, featuring both multiple-choice and true-or-false questions. This assessment tool gauges individuals' comprehension of diabetes, its impact on health, and optimal strategies for managing the condition. The possible score range is 0-17. A higher score indicates a better understanding of diabetes and cardiovascular disease. | Baseline, 6 month follow up, 12 month follow up |
| Changes in physical activity as assessed by Modified Physical Activity Questionnaire (MPAQ) | The MPAQ is a tool used to estimate the frequency in days (number of times per month) and in time (minutes) someone participated in physical activity (e.g. biking, walking, swimming, etc.). Hours per week for all activities are summed to determine activity hours per week averaged over the past year. A higher sum indicates more physical activity. Values can also be weighted by their estimated metabolic cost and expressed as metabolic equivalent (MET) hours per week. Higher METs are associated with better outcomes. The MPAQ also assesses inactivity, such as the average number of hours per day spent watching television or being confined to a bed or chair for more than 1 week. A higher average indicates less physical activity. | Baseline, 6 month follow up, 12 month follow up |
| Change in weight (kgs) | Change from baseline in weight (kgs) | Baseline and 6 month follow-up |
| Change in BMI | Change from baseline in BMI (Kg/m^2). | Baseline and 6 month follow-up |
| Change in hip and waist circumference (centimeters) | Change from baseline in hip and waist circumference (centimeters) | Baseline and 6 month follow up |
| Change in Metabolic Syndrome Severity Z score | Metabolic Syndrome Severity (MetS) Z score calculates an individual's metabolic syndrome severity score by examining five key markers: waist circumference, blood pressure, triglycerides, HDL, and fasting glucose. Score typically ranges from -5 to 5. Higher scores indicate greater metabolic syndrome severity. | Baseline and 6 month follow up |
| Change in self-management as assessed by the Patient Activation Measure (PAM-13). | The Patient Activation Measure is a 13-item survey that will assess an individual's knowledge, skills and confidence to managing one's health and healthcare. The PAM scores is calculated and then transformed to a scale with a range from 0-100. A higher PAM score indicates higher patient activation. The score can also be converted into four activation levels: 1 - not believing activation important, 2 - lack of knowledge and confidence to take action, 3 - beginning to take action, 4 - taking action. | Baseline, 6 month follow up,12 month follow up |
| Change in quality of life and overall health and well-being as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 | The PROMIS Global Health 10 survey comprises 10 items designed to evaluate both physical and mental health status. Scores are aggregated separately for physical and mental health, each ranging from 4 - 20. Higher scores in both categories indicate better outcomes. | Baseline, 6 month follow up,12 month follow up |
| Change in blood pressure (systolic and diastolic (mmHg)) | changes in blood pressure from baseline | Baseline and 6 month follow up |
| Change in cardiac biomarker, gal-3 | Percent change from baseline in gal-3 | Baseline and 6 month follow up |
| Change in cardiac biomarkers, NT-proBNP | Percent change from baseline in NT-proBNP | Baseline and 6 month follow up |
| Change in post-walk Borg dyspnea scale | Changes in post-walk Borg dyspnea scale which ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"); higher score worse breathing difficulty. Measured in a subset of the population. | Baseline and 6 month follow up |
| Change in cardiorespiratory fitness as assessed by peak oxygen uptake (V02 peak) | Change in peak oxygen uptake (VO2 peak) as assessed by a cardiopulmonary fitness test in a subset of the population. | Baseline and 6 month follow up |
| Johns Hopkins University Comstock Center | Not yet recruiting | Hagerstown | Maryland | 21740 | United States |
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| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |