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

Overview

The study is sponsored by the National Heart, Lung, and Blood Institute, which is part of the National Institutes of Health. The study expects to enroll 400 subjects. The research team will recruit 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

The research team 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.

Interventions

• Behavioral Text Messaging
  On 3 days/week they receive a text about 1 of the 3 behaviors (weight maintenance or loss, physical activity, and medication adherence) in randomized order with guidance for maintaining or improving these behaviors to reach program-provided goals. The system compares their last week's adherence to the responder criteria. They receive feedback praising adherence and instructions for a theory-driven behavioral strategy (e.g., stimulus control) to increase adherence. Feedback is tailored to the pat
• Behavioral Fully Automated Online Program
  Patients receiving the fully automated online program will select a weight loss or a weight maintenance curriculum based on their goals. Patients will receive 8 weeks of fully automated lessons covering the 3 key behaviors: weight (management or loss), physical activity, and medication adherence. All 3 behaviors are discussed weekly, but the lessons first prioritize PA, then weight management, and then medication adherence to mimic the emphasis in Phase II. Total weekly lesson time is 20-30 minu
• Behavioral Low-Intensity Cardiac Rehabilitation Maintenance Program
  Patients are instructed to log in 3 times weekly to view lessons, sync their Fitbit data, and complete a home-based workout video. They track weight, PA, and medication adherence daily. Patients have access to an extensive CR resource library made and curated by the platform provider plus resources on maintaining heart healthy behaviors during Phase III created by the research team. They are reminded to log in if they log in less than twice weekly.
• Behavioral High Intensity Cardiac Rehabilitation Maintenance Program
  Patients are instructed to log in 3 times weekly to view lessons, sync their Fitbit data, and complete a home-based workout video. They track weight, PA, and medication adherence daily and attend a once weekly virtual meeting with a CR case manager. Meetings are modeled after Phase II and focus on tailored exercise prescription, addressing cognitive, behavioral, and environmental adherence barriers, and support. Patients have access to an extensive CR resource library made and curated by the pla

Primary outcome measures

• Weight Management [Time frame: From enrollment to the post-intervention assessment at 6 months]
• Physical Activity [Time frame: From enrollment to the post-intervention assessment at 6 months]
• Medication Adherence [Time frame: From enrollment to the post-intervention assessment at 6 months]

Secondary outcome measures (3)

• Hospitalizations [Time frame: 12 months after enrollment]
• Death [Time frame: 12 months after enrollment]
• Quality of life via the 36-Item Short-Form Survey [Time frame: 12 months after enrollment]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Weight Control and Diabetes Research Center of The Miriam Hospital — Providence

Identifiers

NCT: NCT06886789 · 1R01HL171158-01A1 · 1R01HL171158-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗