Optimizing support to keep health improvements after cardiac rehab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.