NCT06886789 SMART to Optimize an Intervention to Maintain Health Improvements After Cardiac Rehabilitation
| NCT ID | NCT06886789 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Miriam Hospital |
| Condition | Cardiovascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2030-06-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The study is sponsored by the National Heart, Lung, and Blood Institute, which is part of the National Institutes of Health. The study expects to enroll 400 subjects. The research team will recruit research participants that are finishing or will finish cardiac rehabilitation soon. Participants belong to one or more groups of people who are less often studied in cardiac rehabilitation research, may have less access to a formal cardiac rehabilitation maintenance program, or they may especially benefit from additional support after cardiac rehabilitation ends. The main purposes of this study are to evaluate which treatments work the best after cardiac rehabilitation, which order to deliver the treatments in, and which treatments are as minimally burdensome as possible while still working well. This study will make two comparisons (one comparison between a set of low-intensity interventions and another between a set of higher-intensity interventions) to determine which produces the best behavioral adherence immediately after Phase II (outpatient) cardiac rehabilitation
Eligibility Criteria
Inclusion Criteria: * ≥18 years of age or older * Have completed at least 6 CR sessions * Must enroll within 6 weeks of their final CR session * BMI ≥27 * Own an internet-connected device * Home internet access * English proficiency * Able to walk ≥1 block without stopping Lastly, the participant MUST belong to ≥1 of the following groups or identities: * Identifies as a woman * Identifies as LGBTQIA+ * Identifies as a racial or ethnic minority * Insecure transportation for medical appointments * Self-reported trouble paying for healthcare needs (e.g., copays) * Receive income-based subsidized benefits (e.g., state-funded health insurance for low-income residents) * Reside in a small town or rural area per 2010 United States Department of Agriculture Rural-Urban Commuting Area zip code or the Distressed Communities Index * Low educational attainment (≤high school diploma) * Low household income (less than twice the Federal Poverty Level) or meeting federal poverty guidelines per the Nat