Cardiovascular DiseasesEMPOWER MENCT06886789
SMART to Optimize an Intervention to Maintain Health Improvements After Cardiac Rehabilitation
A study testing Text Messaging, Fully Automated Online Program and Low-Intensity Cardiac Rehabilitation Maintenance Program in people with Cardiovascular Diseases and Cardiac Rehabilitation, run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cardiac Rehabilitation
- What is being tested?
- Text Messaging, Fully Automated Online Program and Low-Intensity Cardiac Rehabilitation Maintenance Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Show all 18Show fewer
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weight Control and Diabetes Research Center of The Miriam Hospital
Providence, Rhode Island, 02903
Carly M Goldstein, PhD, FAACVPR, 401-793-8960, carly.goldstein@brownhealth.org
Ana Almeida, 401-793-8950, AAlmeida1@brownhealth.or
About this study
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
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
Read the 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.
- Conditions
- Cardiovascular Diseases, Cardiac Rehabilitation
- Being tested
- Text Messaging, Fully Automated Online Program, Low-Intensity Cardiac Rehabilitation Maintenance Program, High Intensity Cardiac Rehabilitation Maintenance Program
- Keywords
- Cardiovascular disease, Cardiac rehabilitation, Medication adherence, Weight loss, Weight management, Weight maintenance, Physical activity, Intervention optimization, Sequential, multiple assignment, randomized trials, Digital health
- Medical subject headings
- Cardiovascular Diseases, Medication Adherence, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessagingBehavioural
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.
Fully Automated Online ProgramBehavioural
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.
Low-Intensity Cardiac Rehabilitation Maintenance ProgramBehavioural
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.
High Intensity Cardiac Rehabilitation Maintenance ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Fully Automated Online Program; Behavioral: High Intensity Cardiac Rehabilitation Maintenance Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the post-intervention assessment at 6 months
Secondary outcomes (3)
Hospitalizations
Number of hospitalizations
Measured: 12 months after enrollment
Death
Patients, the designated contacts, or the medical chart will provide information in the event that the participant has passed away since enrollment
Measured: 12 months after enrollment
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.
Measured: 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Apr 2026
- Primary completion30 Jun 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential, Multiple Assignment, Randomized Trial (SMART)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Office of the Director, National Institutes of Health (OD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886789
- Sponsor's protocol ID
- 1R01HL171158-01A1
- Other IDs
- 1R01HL171158-01A1
- Acronym
- EMPOWER ME
- Status last verified
- Feb 2026
- First submitted
- 14 Mar 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the risk of re-identification in some communities, IPD will not be shared in this study.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06886789
- Acronym / sponsor ID
- EMPOWER ME / 1R01HL171158-01A1
- Conditions
- Cardiovascular Diseases, Cardiac Rehabilitation
- Keywords
- Cardiovascular disease, Cardiac rehabilitation, Medication adherence, Weight loss, Weight management, Weight maintenance, Physical activity, Intervention optimization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Office of the Director, National Institutes of Health (OD)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- Sequential, Multiple Assignment, Randomized Trial (SMART)
| Arm | Type | Receives |
|---|---|---|
| First Intervention: Text Messaging, Second Intervention: Continued Text Messaging | Experimental | Behavioral: Text MessagingParticipants 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. |
| First Intervention: Text Messaging, Second Intervention: Low-Intensity Cardiac Rehabilitation | Experimental | Behavioral: Text Messaging, Behavioral: Low-Intensity Cardiac Rehabilitation Maintenance ProgramParticipants 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. |
| First Intervention: Text Messaging, Second Intervention: High-Intensity Cardiac Rehabilitation | Experimental | Behavioral: Text Messaging, Behavioral: High Intensity Cardiac Rehabilitation Maintenance ProgramParticipants 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. |
| First Intervention: Fully Automated Online Program (FAOP), Second Intervention: Continued FAOP | Experimental | Behavioral: Fully Automated Online ProgramPatients 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. |
| First Intervention: FAOP, Second Intervention: Low-Intensity Cardiac Rehabilitation | Experimental | Behavioral: Fully Automated Online Program, Behavioral: Low-Intensity Cardiac Rehabilitation Maintenance ProgramParticipants 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. |
| First Intervention: FAOP, Second Intervention: High-Intensity Cardiac Rehabilitation | Experimental | Behavioral: Fully Automated Online Program, Behavioral: High Intensity Cardiac Rehabilitation Maintenance ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- ≥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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text MessagingOn 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. | Behavioural | 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 ProgramPatients 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. | Behavioural | 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 |
| Low-Intensity Cardiac Rehabilitation Maintenance ProgramPatients 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. | Behavioural | First Intervention: FAOP, Second Intervention: Low-Intensity Cardiac Rehabilitation, First Intervention: Text Messaging, Second Intervention: Low-Intensity Cardiac Rehabilitation |
| High Intensity Cardiac Rehabilitation Maintenance ProgramPatients 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. | Behavioural | First Intervention: FAOP, Second Intervention: High-Intensity Cardiac Rehabilitation, First Intervention: Text Messaging, Second Intervention: High-Intensity Cardiac Rehabilitation |
Primary outcome
Weight Management
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to the risk of re-identification in some communities, IPD will not be shared in this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messaging, Fully Automated Online Program and Low-Intensity Cardiac Rehabilitation Maintenance Program in people with Cardiovascular Diseases and Cardiac Rehabilitation, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carly M Goldstein, PhD, FAACVPR (401-793-8960, carly.goldstein@brownhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Management (time frame: From enrollment to the post-intervention assessment at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.