Optimizing support to keep health improvements after cardiac rehab
An Application of SMART Methodology to Optimize an Intervention to Maintain Improvements in Health Behaviors in Under-resourced Patients After Phase II Cardiac Rehabilitation
We will test two easy online programs first and, for people who don't respond, try one of two home-based programs to help adults finishing cardiac rehab—especially those from underrepresented or low-resource groups with BMI ≥27—stay active, manage weight, and take their medicines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Miriam Hospital Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT06886789 on ClinicalTrials.gov |
What this trial studies
This randomized SMART design first compares a low-intensity text-messaging program (three weekly message sets for two months) with a fully automated two-month online program of lessons, self-monitoring, and tailored feedback. Participants who do not respond to their initial assignment are re-randomized to either a low-intensity home-based cardiac rehab maintenance program (education and exercise prescription) or a higher-intensity home-based program that adds case management for three months. Adherence to three cardioprotective behaviors—physical activity, weight management, and medication adherence—is measured at baseline, Month 3, Month 6, and at a 12-month follow-up, with responder status defined by the SMART decision rule and individual behavior measures reported separately. The study aims to enroll about 400 adults finishing cardiac rehabilitation, prioritizing people who are women, racial/ethnic minorities, LGBTQIA+, low-income, have limited transportation, lower education, or live in rural/underserved areas.
Who should consider this trial
Good fit: Adults aged 18 or older who have completed at least six cardiac rehab sessions and enroll within six weeks of their final session, have BMI ≥27, home internet and an internet-connected device, can walk at least one block, read English, and belong to at least one targeted underserved or underrepresented group are ideal candidates.
Not a fit: People without reliable home internet or an internet-connected device, those who cannot walk one block, those with BMI below 27, or those who need supervised, in-person cardiac rehab are less likely to benefit from these interventions.
Why it matters
Potential benefit: If successful, the approach could provide a low-burden, scalable way to help people maintain exercise, weight control, and medication routines after cardiac rehab without frequent clinic visits.
How similar studies have performed: Previous work has shown that automated online programs and home-based cardiac rehab can improve behaviors, and this protocol builds on that evidence but uses a stepped SMART design to find the best sequence of low- and higher-intensity options.
Eligibility criteria
Show full inclusion / exclusion 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 National Committee on Vital and Health Statistics and the Department of Health and Human Services) Exclusion Criteria: * 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
Where this trial is running
Providence, Rhode Island
- Weight Control and Diabetes Research Center of The Miriam Hospital — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Carly M Goldstein, PhD, FAACVPR
- Email: carly.goldstein@brownhealth.org
- Phone: 401-793-8960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.