Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure
NCT ID: NCT06364644
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
210 participants
INTERVENTIONAL
2025-06-20
2027-03-31
Brief Summary
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Detailed Description
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1. 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.
2. 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:
* Reinforcing patient education about disease self-management
* Helping patients access care and addressing barriers to care and treatment
* Serving as facilitators and navigators to clinical care, social services, and other community resources
* Providing encouragement and support to engage, activate, and empower patients and their support systems
3. 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Community Champions
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.
Community Champions
The UNLOAD-Heart Failure Program intervention includes problem solving training, community health worker support, and exercise support from health coaches at YMCAs.
Homegrown Heroes
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 .
Homegrown Heroes
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.
Interventions
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Community Champions
The UNLOAD-Heart Failure Program intervention includes problem solving training, community health worker support, and exercise support from health coaches at YMCAs.
Homegrown Heroes
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Low socioeconomic status (SES) by high Area Deprivation Index (ADI) \[\>75th percentile for the state of Maryland\] plus low income)
* Type 2 diabetes
* Obesity (BMI≥30 kg/m\^2)
Exclusion Criteria
* Prevalent heart failure
* Uncontrolled glycemia (blood glucose \<60 mg/d or ≥ 300 mg/dl or most recent hemoglobin A1c ≥11%)
* Uncontrolled blood pressure (Systolic blood pressure (SBP) ≥160 or diastolic blood pressure (DBP) ≥100 mm Hg, either on or off medications)
* Known coronary artery disease (unless \< 50% stenosis by angiography)
* Moderate or severe valvular heart disease
* Serious medical conditions limiting life expectancy or requiring active management
* Inability to participate in moderate intensity physical activity as assessed by the self-report Physical Activity Readiness Questionnaire Plus (PAR-Q+).
* Weight loss of ≥ 5% in the past year or current use of weight loss medications
* Any condition or planned surgery/procedure precluding exercise for ≥ 150 minutes per week
* End stage renal disease
* Current participation in another behavior change program
* Active alcohol or substance abuse disorder
* Already engaging in regular exercise with more than 60 minutes of moderate \[3-6 METS\] to vigorous \[\>6 METS\] physical activity per week
* Active pregnancy
* Evidence of ischemia, dangerous arrhythmia or other clinical instability on baseline exercise stress test
30 Years
70 Years
ALL
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Chiadi Ndumele, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Medicine
Locations
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Johns Hopkins Center for Health Equity
Baltimore, Maryland, United States
Johns Hopkins University Comstock Center
Hagerstown, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Melissa Minotti, MPH, RPSGT, CCRC
Role: primary
Other Identifiers
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IRB00336599
Identifier Type: -
Identifier Source: org_study_id
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