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

Not Applicable

Not yet recruiting

• Conditions: Cardiovascular Diseases; Cardiac Rehabilitation

• Registration Number: NCT06886789
• Lead Sponsor: The Miriam Hospital

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 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

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 health behaviors for 2 months, or \[B\] a fully automated 2-month online program modeled on our previous research, consisting of interactive lessons, self-monitoring, and tailored feedback) serves as the best first-line intervention. The second test is which of two home-based cardiac rehabilitation (CR) maintenance interventions produces the best outcomes for non-responders to the initial interventions. Those who do not respond to the low-intensity interventions will be randomized to receive 3 months of either (C) low-intensity home-based CR, consisting of education and exercise prescription, or (D) high-intensity home-based online CR that includes education and exercise prescription plus case management. Adherence to the 3 targeted cardioprotective behaviors will be measured after Phase II completion (baseline), the initial low-touch interventions (at Month 3), after 3 more months of continued or new interventions (at Month 6), and 6-months of no-treatment follow-up (at Month 12). The primary outcome will be adherence to the 3 cardioprotective behaviors (physical activity, weight management, and medication adherence) measured together in the Sequential, Multiple Assignment, Randomized Trials (SMART) decision rule (responder status) and individually. Exploratory outcomes will be death, rehospitalization, and quality of life. The specific aims of this study are to: (1) Compare the 2 least intensive, online, intervention options (text message versus an automated online program) to determine which produces the best behavioral adherence immediately after Phase II CR; (2) Determine whether low- or high-intensity home-based CR (i.e., with or without case management) produces superior behavioral adherence after failure of initial low-intensity online intervention; (3) Finalize the adaptive treatment based on the results of the first two aims; and (4) \[Exploratory Aim\] Conduct a moderators analysis to test for differential effects within specific participant groups.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-14
• Last Update Submitted: 2025-03-14
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Study Start: 2025-08-01
• Primary Completion: 2029-10-07
• Study Completion: 2030-03-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Weight Management	From enrollment to the post-intervention assessment at 6 months	Weight will be measured to the nearest 0.1 kg with a digital scale in light indoor clothing without shoes. Height will be measured to the nearest millimeter with standard stadiometer procedures; those without a recent (≤3 months) clinic height measurement will be sent a paper tape measure to be taped to a wall. BMI will be calculated (kg/m2). Local participants may come to the research center. Patients will be shipped a cellular-enabled scale to be used in the same location in their home for all assessments and will keep scales between assessments. Percent weight loss or management will be calculated as current weight/baseline weight.
Physical Activity	From enrollment to the post-intervention assessment at 6 months	PA will be objectively measured over the 7-day assessment period via wearing the Fitbit on their wrist during waking hours. The Clinical Research Technologist can monitor device wear time during assessments and prompt participants to wear the device during their assessment period. Valid wear days will be defined as ≥600 min wear time during awake hours (e.g., 7am to 11pm; hours chosen with participant input) measured by non-zero heart rate measurements during that time and include patients with ≥4 valid days, including 1 weekend day. Fitbit allows researchers access to raw sensor data in 60 sec epochs via their API. Estimated mins/day spent in total PA and specific intensities of activities will be based on vertical axis counts/min thresholds primarily reflecting locomotor activity. The primary PA variable of interest will be MVPA mins/week.
Medication Adherence	From enrollment to the post-intervention assessment at 6 months	Participants will complete a pill count of their total supply of common CVD medications. The medications will be counted at the assessment week beginning and end. Patients will complete the count twice; if the 2 do not agree, they will complete a third. The total number of pills will be recorded at each pill count. Percent adherence for each medication will be calculated as the difference between the baseline and end-of-treatment counts for that medication divided by the number of prescribed pills for that medication; this value will be multiplied by 100. Percent adherence per medication will be the difference between the baseline and end-of-treatment counts for that medication divided by the number of prescribed pills for that medication multiplied by 100. Percent adherence across medications will be the difference between baseline and end-of-treatment counts across all medications divided by the total number of prescribed pills for the 7-day period multiplied by 100.

Secondary Outcome Measures

Name	Time	Method
Hospitalizations	12 months after enrollment	Number of hospitalizations
Death	12 months after enrollment	Patients, the designated contacts, or the medical chart will provide information in the event that the participant has passed away since enrollment
Quality of life via the SF-36	12 months after enrollment	Participants who are reached for the final assessment will complete a short survey form online or on the phone to measure their quality of life

Trial Locations

Locations (1)

Weight Control and Diabetes Research Center of The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States