Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure (NCT06364644)
Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure (UNLOAD-Heart Failure)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (16 items).
Location: Johns Hopkins Center for Health Equity — Baltimore, Maryland
Age range: 30 Years to 70 Years
🧪 Interventions in This Study
- Community Champions (BEHAVIORAL)
- Homegrown Heroes (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Age \< 30 or \>70 years
- 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+).
- Any condition or planned surgery/procedure precluding exercise for ≥ 150 minutes per week
- End-stage renal disease
- Current participation in another behavior change program
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- Johns Hopkins Center for Health Equity — Baltimore, Maryland
- Johns Hopkins University Comstock Center — Hagerstown, Maryland
📞 Contact the Study Coordinator
Phone: (410) 502-2319
Email: cndumel2@jhmi.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: Community Health Worker Support: Participants will receive ongoing support from community health workers as part of the intervention.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.