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

NCT06886789 | Recruiting

• 1 other identifier: 1R01HL171158-01A1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Cardiac Rehabilitation; Cardiovascular Diseases

Keywords

Cardiovascular disease; Cardiac rehabilitation; Medication adherence; Weight loss; Weight management; Weight maintenance; Physical activity; Intervention optimization; Sequential, multiple assignment, randomized trials; Digital health

Outcome Measures

Primary Outcomes (3)

• Weight Management

  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.

  From enrollment to the post-intervention assessment at 6 months

• Physical Activity

  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.

  From enrollment to the post-intervention assessment at 6 months

• Medication Adherence

  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.

  From enrollment to the post-intervention assessment at 6 months

Secondary Outcomes (3)

• Hospitalizations

  12 months after enrollment

• Death

  12 months after enrollment

• Quality of life via the 36-Item Short-Form Survey

  12 months after enrollment

Study Arms (6)

First Intervention: Text Messaging, Second Intervention: Continued Text Messaging

EXPERIMENTAL

Participants are first randomized to the low-intensity text messaging intervention. 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. Participants meeting responder criteria after 2 months will continue to receive the text messaging intervention for the next 3 months.

Behavioral: Text Messaging

First Intervention: Text Messaging, Second Intervention: Low-Intensity Cardiac Rehabilitation

EXPERIMENTAL

Participants receive the text messaging intervention for 2 months. Following their mid-intervention assessment, they are randomized to receive the 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: Text Messaging; Behavioral: Low-Intensity Cardiac Rehabilitation Maintenance Program

First Intervention: Text Messaging, Second Intervention: High-Intensity Cardiac Rehabilitation

EXPERIMENTAL

Participants receive the text messaging intervention for 2 months. Following their mid-intervention assessment, they are randomized to receive the 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.

Behavioral: Text Messaging; Behavioral: High Intensity Cardiac Rehabilitation Maintenance Program

First Intervention: Fully Automated Online Program (FAOP), Second Intervention: Continued FAOP

EXPERIMENTAL

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. Participants meeting responder criteria after 2 months will continue to receive the fully automated online program.

Behavioral: Fully Automated Online Program

First Intervention: FAOP, Second Intervention: Low-Intensity Cardiac Rehabilitation

EXPERIMENTAL

Participants receive the fully automated online program for 2 months. Following their mid-intervention assessment, they are randomized to receive the 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: Fully Automated Online Program; Behavioral: Low-Intensity Cardiac Rehabilitation Maintenance Program

First Intervention: FAOP, Second Intervention: High-Intensity Cardiac Rehabilitation

EXPERIMENTAL

Participants receive the fully automated online program intervention for 2 months. Following their mid-intervention assessment, they are randomized to receive the 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 (after they miss a login) if they log in less than twice weekly.

Behavioral: Fully Automated Online Program; Behavioral: High Intensity Cardiac Rehabilitation Maintenance Program

Interventions

Low-Intensity Cardiac Rehabilitation Maintenance Program BEHAVIORAL

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.

First Intervention: FAOP, Second Intervention: Low-Intensity Cardiac Rehabilitation; First Intervention: Text Messaging, Second Intervention: Low-Intensity Cardiac Rehabilitation

High Intensity Cardiac Rehabilitation Maintenance Program BEHAVIORAL

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.

First Intervention: FAOP, Second Intervention: High-Intensity Cardiac Rehabilitation; First Intervention: Text Messaging, Second Intervention: High-Intensity Cardiac Rehabilitation

Text Messaging BEHAVIORAL

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.

First Intervention: Text Messaging, Second Intervention: Continued Text Messaging; First Intervention: Text Messaging, Second Intervention: High-Intensity Cardiac Rehabilitation; First Intervention: Text Messaging, Second Intervention: Low-Intensity Cardiac Rehabilitation

Fully Automated Online Program BEHAVIORAL

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.

First Intervention: FAOP, Second Intervention: High-Intensity Cardiac Rehabilitation; First Intervention: FAOP, Second Intervention: Low-Intensity Cardiac Rehabilitation; First Intervention: Fully Automated Online Program (FAOP), Second Intervention: Continued FAOP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Office of the Director, National Institutes of Health (OD): collaborator

Study Sites (1)

Weight Control and Diabetes Research Center of The Miriam Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Related Links

• Study Website

MeSH Terms

Conditions

Cardiovascular Diseases; Medication Adherence; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Carly M Goldstein, PhD, FAACVPR

CONTACT

401-793-8960; carly.goldstein@brownhealth.org

Kristen Walaska, BS

CONTACT

401-793-8022; kwalaska@brownhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential, Multiple Assignment, Randomized Trial (SMART)

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: April 28, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)