Cardiac Rehabilitation, Cardiovascular Diseases
Conditions
Keywords
Cardiovascular disease, Cardiac rehabilitation, Medication adherence, Weight loss, Weight management, Weight maintenance, Physical activity, Intervention optimization, Sequential, multiple assignment, randomized trials, Digital health
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
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
BEHAVIORALText 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.
BEHAVIORALFully 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.
BEHAVIORALLow-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.
BEHAVIORALHigh 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
The Miriam Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Office of the Director, National Institutes of Health (OD)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Sequential, Multiple Assignment, Randomized Trial (SMART)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Management | From enrollment to the post-intervention assessment at 6 months | 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. |
| Physical Activity | From enrollment to the post-intervention assessment at 6 months | 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. |
| Medication Adherence | From enrollment to the post-intervention assessment at 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalizations | 12 months after enrollment | Number of hospitalizations |
| Death | 12 months after enrollment | Patients, the designated contacts, or the medical chart will provide information in the event that the participant has passed away since enrollment |
| Quality of life via the 36-Item Short-Form Survey | 12 months after enrollment | 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. |
Countries
United States
Contacts
CONTACTCarly M Goldstein, PhD, FAACVPR
CONTACTKristen Walaska, BS
Outcome results
None listed