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SMART to Optimize an Intervention to Maintain Health Improvements After Cardiac Rehabilitation

Study acronym: EMPOWER ME
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Start date changed from estimate of Mar 2, 2026 to Apr 1, 2026v3
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Primary completion date: Oct 7, 2029 to Jun 30, 2030
    • Start date: Aug 1, 2025 to Mar 2, 2026
    • Study completion date: Mar 29, 2030 to Aug 2030
    • Secondary endpoints revised (3)
    • Site details revised
    • Eligibility criteria expanded, about 5 words
    • Study description expanded, about 2 words
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06886789
Lead Sponsor The Miriam Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Office of the Director, National Institutes of Health (OD)
Conditions
(from sponsor)
Cardiovascular Diseases, Cardiac Rehabilitation
Related terms Cardiovascular Diseases, Medication Adherence, Motor Activity, Weight Loss
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov