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

Summary

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

Conditions

• Cardiovascular Diseases
• Cardiac Rehabilitation

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 patient's adherence or existence of self-monitoring data.

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 minutes. Patients retain access to lessons. They self-monitor calories, weight, moderate-to-vigorous physical activity, and medication adherence. Tracking data are seamlessly integrated into the system. They manually enter their medication adherence data and receive encouraging feedback on each of the behaviors the next week.

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 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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Office of the Director, National Institutes of Health (OD)

  collaborator UNKNOWN

• The Miriam Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2030-06-30

Completion

2030-08-31

Countries

• United States

Study Locations