Status:
NOT_YET_RECRUITING
SMART to Optimize an Intervention to Maintain Health Improvements After Cardiac Rehabilitation
Lead Sponsor:
The Miriam Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Office of the Director, National Institutes of Health (OD)
Conditions:
Cardiovascular Diseases
Cardiac Rehabilitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is sponsored by the National Heart, Lung, and Blood Institute, which is part of the National Institutes of Health. We expect to enroll 400 subjects into this study. We will be recruiting res...
Detailed Description
We will first test which of two automated online interventions (\[A\] a low-intensity text-messaging intervention of 3 weekly sets of text messages focused on encouragement and reminders about the key...
Eligibility Criteria
Inclusion
- ≥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
- Low educational attainment (≤high school diploma)
- Low household income (less than twice the Federal Poverty Level) or meeting federal poverty guidelines per the National Committee on Vital and Health Statistics and the Department of Health and Human Services)
Exclusion
- New York Heart Association Class IV heart failure
- Heart transplant in the last 5 months
- Left ventricular assist device in the last 4 months
- Physician diagnosis of dementia
- Physician prescription for 24 hours of oxygen therapy daily
- Coronary artery bypass surgery in the last 3 months
- Current dialysis
- Chronic gait or balance disturbances that would make unsupervised exercise unsafe
- Current pregnancy
- Report of conditions that the investigators believe would render them potentially unlikely to follow the protocol including terminal illness, active substance dependence, or other significant psychiatric problems that require inpatient hospitalization
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 29 2030
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06886789
Start Date
August 1 2025
End Date
March 29 2030
Last Update
March 20 2025
Active Locations (1)
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1
Weight Control and Diabetes Research Center of The Miriam Hospital
Providence, Rhode Island, United States, 02903