Clinical trial NCT06886789: SMART to Optimize an Intervention to Maintain Health Improvements After Cardiac Rehabilitation
Official title: An Application of SMART Methodology to Optimize an Intervention to Maintain Improvements in Health Behaviors in Under-resourced Patients After Phase II Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Cardiac Rehabilitation
Keywords: Cardiovascular disease
Cardiac rehabilitation
Medication adherence
Weight loss
Weight management
Weight maintenance
Physical activity
Intervention optimization
Sequential, multiple assignment, randomized trials
Digital health
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Office of the Director, National Institutes of Health (OD)
First posted: 2025-03-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential, Multiple Assignment, Randomized Trial (SMART)
Primary purpose: TREATMENT

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.

Eligibility 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
* 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

Primary outcomes:
measure: Weight Management
timeFrame: From enrollment to the post-intervention assessment at 6 months
measure: Physical Activity
timeFrame: From enrollment to the post-intervention assessment at 6 months
measure: Medication Adherence
timeFrame: From enrollment to the post-intervention assessment at 6 months
Secondary outcomes:
measure: Hospitalizations
timeFrame: 12 months after enrollment
measure: Death
timeFrame: 12 months after enrollment
measure: Quality of life via the SF-36
timeFrame: 12 months after enrollment
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center of The Miriam Hospital
state: Rhode Island
Study officials:
References: