SMART to Optimize an Intervention to Maintain Health Improvements After Cardiac Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Miriam Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Text Messaging
BehavioralOn 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.
Fully Automated Online Program
BehavioralPatients 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.
Low-Intensity Cardiac Rehabilitation Maintenance Program
BehavioralPatients 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.
High Intensity Cardiac Rehabilitation Maintenance Program
BehavioralPatients 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.
Treatment groups
400 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: First Intervention: Text Messaging, Second Intervention: Continued Text MessagingExperimental treatment 1 intervention
Group B: First Intervention: Text Messaging, Second Intervention: Low-Intensity Cardiac RehabilitationExperimental treatment 2 interventions
Group C: First Intervention: Text Messaging, Second Intervention: High-Intensity Cardiac RehabilitationExperimental treatment 2 interventions
Group D: First Intervention: Fully Automated Online Program (FAOP), Second Intervention: Continued FAOPExperimental treatment 1 intervention
Group E: First Intervention: FAOP, Second Intervention: Low-Intensity Cardiac RehabilitationExperimental treatment 2 interventions
Group F: First Intervention: FAOP, Second Intervention: High-Intensity Cardiac RehabilitationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the post-intervention assessment at 6 months2
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.
Time frame
From enrollment to the post-intervention assessment at 6 months3
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.
Time frame
From enrollment to the post-intervention assessment at 6 monthsSecondary outcomes
1
Hospitalizations
Number of hospitalizations
Time frame
12 months after enrollment2
Death
Patients, the designated contacts, or the medical chart will provide information in the event that the participant has passed away since enrollment
Time frame
12 months after enrollment3
Quality of life via the 36-Item Short-Form Survey
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. This survey has 36 questions. Each question has 2-5 possible answer options. Responses are recoded to be on a 0-100 scale, and higher values indicate better perceived health.
Time frame
12 months after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Miriam Hospital
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Office of the Director, National Institutes of Health (OD)
Collaborator
Source ClinicalTrials.gov