Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR001874 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
Not provided
Not provided
Not provided
Not provided
This study investigates the feasibility of conducting a randomized controlled trial of telehealth-enhanced hybrid cardiac rehabilitation (THCR) compared with traditional cardiac rehabilitation (CR) among acute coronary syndrome (ACS) survivors. THCR is a novel, hybrid model that targets the same core components as traditional CR (e.g., exercise training, patient education, and risk factor management), but uses a mixture of telehealth, clinic-, and home-based activities to offer 24 CR sessions (5 clinic-based + 19 home-based) over 12 weeks.
Pilot study ran from March 2022 to May 2023. In 2023, intervention became unavailable, due to a telehealth vendor transition across the implementation site's healthcare system, which necessitated new remote patient monitoring platform to offer the experimental arm. Therefore, the study completed with 10 accrued.
Cardiac Rehabilitation (CR) is a Class I, Level A secondary prevention program that significantly reduces reinfarction and mortality rates in acute coronary syndrome (ACS) survivors. Yet, fewer than 30% of eligible cardiac patients participate in and adhere to CR programs in the United States. One promising avenue for increasing CR participation and adherence is a telehealth-enhanced hybrid CR (THCR) model that combines telehealth, clinic- and home-based CR. Several expert groups have strongly endorsed hybrid CR models that integrate telehealth (i.e., mobile apps, remote monitoring devices) because of their ability to offer the "best of both worlds" (i.e., in-clinic supervision/safety and at-home convenience) while also promoting real-time patient-provider communication and reimbursement as a telemedicine service. Despite its potential, the feasibility of and degree to which THCR improves adherence (e.g., # of completed sessions) and clinical outcomes (e.g., functional capacity) relative to traditional CR requires additional investigation. To understand the feasibility of THCR, the investigator will conduct a single center, two-arm, 1:1 parallel group randomized pilot study comparing THCR with traditional CR among ACS patients (N=40) to evaluate the feasibility (e.g., recruitment, adherence) of conducting an adequately powered randomized controlled trial.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth-enhanced Hybrid CR | Experimental | Participants will receive a hybrid version of cardiac rehabilitation. |
|
| Traditional CR | Active Comparator | Participants will receive a standard of care version of cardiac rehabilitation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth-enhanced Hybrid CR | Behavioral | Participants in this group attend a total of 24 CR sessions (5 clinic-based + 19 home-based) over a 12-week period. Clinic-based sessions occur during the first week of the program and at the end of each month. Home-based sessions take place remotely once or twice per week via telehealth, depending on the week of the program. Patients are provided with onboarding sessions, remote patient monitoring devices (tablet, pulse oximeter, blood pressure monitor and cuff) and home-based exercise equipment (e.g., stationary bike and weights). Each CR session (clinic and home) is 60 minutes in duration and includes aerobic and resistance exercise training. Patients will also be asked to complete educational videos, as well as document their physical activity, dietary intake, medication management and homework sessions via surveys. Patients will be encouraged (but not required) to achieve ≥30 minutes of moderate aerobic activity, such as brisk walking, on ≥5 days per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Are Successfully Enrolled Into the Pilot Study Per Month | As a measure of enrollment feasibility, the investigator will assess the number of participants who completed recruitment activities and were successfully consented and enrolled into the pilot study per month. | During enrollment, 11 months |
| Mean Proportion of CR Sessions Completed by Participants Allocated to the THCR Intervention | As a measure of THCR adherence, the investigator will assess the proportion of CR sessions completed by participants allocated to the THCR intervention, which includes 19 home-based + 5 clinic-based sessions. | Assessed after enrollment (baseline) and until pilot study completion (approximately 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants That Attend ≥1 CR Session After Randomization in Each Arm | This is to assess the feasibility of program initiation among participants allocated to each arm. Participants who attended more than 1 CR session will be tallied. Numerator = total number of participants randomized into each arm who attended at least 1 CR session. Denominator = total number of participants randomized into each arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Distance Traveled in 6MWT | This is to measure pre-to-post program change in functional capacity (using the six-minute walk test [6MWT]) among THCR and, separately, traditional CR participants. The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The total distance (meters) traveled over a time period of six minutes is used as the outcome by which to compare changes in performance capacity. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrea T Duran, PhD | Columbia University | Principal Investigator |
| Daichi Shimbo, MD | Columbia University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31931615 | Background | Ritchey MD, Maresh S, McNeely J, Shaffer T, Jackson SL, Keteyian SJ, Brawner CA, Whooley MA, Chang T, Stolp H, Schieb L, Wright J. Tracking Cardiac Rehabilitation Participation and Completion Among Medicare Beneficiaries to Inform the Efforts of a National Initiative. Circ Cardiovasc Qual Outcomes. 2020 Jan;13(1):e005902. doi: 10.1161/CIRCOUTCOMES.119.005902. Epub 2020 Jan 14. | |
| 31082266 | Background | Thomas RJ, Beatty AL, Beckie TM, Brewer LC, Brown TM, Forman DE, Franklin BA, Keteyian SJ, Kitzman DW, Regensteiner JG, Sanderson BK, Whooley MA. Home-Based Cardiac Rehabilitation: A Scientific Statement From the American Association of Cardiovascular and Pulmonary Rehabilitation, the American Heart Association, and the American College of Cardiology. Circulation. 2019 Jul 2;140(1):e69-e89. doi: 10.1161/CIR.0000000000000663. Epub 2019 May 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Telehealth-enhanced Hybrid CR | Participants will receive a hybrid version of cardiac rehabilitation. |
| FG001 | Traditional CR | Participants will receive a standard of care version of cardiac rehabilitation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Telehealth-enhanced Hybrid CR | Participants will receive a hybrid version of cardiac rehabilitation. |
| BG001 | Traditional CR | Participants will receive a standard of care version of cardiac rehabilitation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Are Successfully Enrolled Into the Pilot Study Per Month | As a measure of enrollment feasibility, the investigator will assess the number of participants who completed recruitment activities and were successfully consented and enrolled into the pilot study per month. | Posted | Mean | Standard Error | Participants enrolled per month | During enrollment, 11 months |
|
|
Throughout study duration, approx 14 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telehealth-enhanced Hybrid CR | Participants will receive a hybrid version of cardiac rehabilitation. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low hemoglobin level | Investigations | Non-systematic Assessment |
In 2023, the study was paused due to a system-wide telehealth vendor transition that disrupted access to the remote patient monitoring platform supporting the Telehealth-Enhanced Hybrid Cardiac Rehabilitation intervention. This disruption limited our ability to enroll participants over the intended 2-year period, and the study ultimately closed with 10 participants enrolled over an 11-month period of active enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrea T. Duran, Assistant Professor of Medical Sciences | Columbia University Irving Medical Center | 212.342.4491 | atd2127@cumc.columbia.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2025 | Aug 1, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Traditional CR | Behavioral | Participants in this group attend a total of 24 clinic-based CR sessions according to standard of care protocols over a 12-week period. Each CR session is 60 minutes in duration and includes aerobic and resistance exercise training. In addition to scheduled sessions, patients will be asked to complete educational videos, as well as document their physical activity, dietary intake, medication management and homework sessions via surveys. Patients will be encouraged (but not required) to achieve ≥30 minutes of moderate aerobic activity, such as brisk walking, on ≥5 days per week. |
|
| During 12-week follow-up period (Up to 12 weeks) |
| Mean Proportion of CR Sessions Completed by Those Allocated to the Traditional CR Intervention | As a measure of traditional CR adherence, the investigator will assess the proportion of CR sessions completed by those allocated to the traditional CR intervention, which includes 24 clinic-based sessions. | Assessed after enrollment (baseline) and until pilot study completion (approximately 12 weeks) |
| Proportion of Participants Who Report Adequate Feasibility of the THCR Intervention | This outcome assesses the proportion of participants in the THCR arm who report an average score ≥4 on the Feasibility of Intervention Measure (FIM), a 4-item scale evaluating patient-perceived feasibility of the intervention. Each item is rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). Individual item scores are summed (possible range: 4 to 20) and averaged (possible range: 1 to 5). Participants with a mean score ≥4 ("agree" or "strongly agree" on average) are considered to perceive the intervention as adequately feasible. Higher scores indicate greater feasibility. | At study completion (approximately 12 weeks) |
| Baseline and 3-month post program completion (Week 12) |
| Change in Health-related Quality of Life Score | This is to measure pre-to-post program change in health-related quality of life (Duke health profile questionnaire [DUKE; physical, mental, social, and general health composite scores]) among THCR and, separately, traditional CR participants (composite score). The DUKE is a 17-item self-report questionnaire for measuring generic health-related quality of life over a 1-week time period. Responses are scored to calculate physical health, mental health, and social health scores, which are then summed and divided by 3 to obtain a general health score. The general health score ranges from 0 - 100, with high scores indicating better health-related quality of life. | Baseline and 3-month post program completion (Week 12) |
| 25249585 | Background | Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ; ACC/AHA Task Force Members. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 23;130(25):e344-426. doi: 10.1161/CIR.0000000000000134. Epub 2014 Sep 23. No abstract available. |
| 22052934 | Background | Smith SC Jr, Benjamin EJ, Bonow RO, Braun LT, Creager MA, Franklin BA, Gibbons RJ, Grundy SM, Hiratzka LF, Jones DW, Lloyd-Jones DM, Minissian M, Mosca L, Peterson ED, Sacco RL, Spertus J, Stein JH, Taubert KA; World Heart Federation and the Preventive Cardiovascular Nurses Association. AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and other Atherosclerotic Vascular Disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation. Circulation. 2011 Nov 29;124(22):2458-73. doi: 10.1161/CIR.0b013e318235eb4d. Epub 2011 Nov 3. No abstract available. |
| 31423874 | Background | Imran HM, Baig M, Erqou S, Taveira TH, Shah NR, Morrison A, Choudhary G, Wu WC. Home-Based Cardiac Rehabilitation Alone and Hybrid With Center-Based Cardiac Rehabilitation in Heart Failure: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2019 Aug 20;8(16):e012779. doi: 10.1161/JAHA.119.012779. Epub 2019 Aug 17. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | Participants |
|
| Six Minute Walk Test Distance | Mean | Standard Deviation | meters |
|
| Health-related Quality of Life Score | Mean | Standard Deviation | score on a scale |
|
|
|
| Primary | Mean Proportion of CR Sessions Completed by Participants Allocated to the THCR Intervention | As a measure of THCR adherence, the investigator will assess the proportion of CR sessions completed by participants allocated to the THCR intervention, which includes 19 home-based + 5 clinic-based sessions. | Posted | Mean | Standard Error | Proportion of CR Sessions Completed | Assessed after enrollment (baseline) and until pilot study completion (approximately 12 weeks) |
|
|
|
|
| Secondary | Proportion of Participants That Attend ≥1 CR Session After Randomization in Each Arm | This is to assess the feasibility of program initiation among participants allocated to each arm. Participants who attended more than 1 CR session will be tallied. Numerator = total number of participants randomized into each arm who attended at least 1 CR session. Denominator = total number of participants randomized into each arm. | Posted | Number | proportion of participants | During 12-week follow-up period (Up to 12 weeks) |
|
|
|
|
| Secondary | Mean Proportion of CR Sessions Completed by Those Allocated to the Traditional CR Intervention | As a measure of traditional CR adherence, the investigator will assess the proportion of CR sessions completed by those allocated to the traditional CR intervention, which includes 24 clinic-based sessions. | Posted | Mean | Standard Error | Proportion of CR Sessions Completed | Assessed after enrollment (baseline) and until pilot study completion (approximately 12 weeks) |
|
|
|
|
| Secondary | Proportion of Participants Who Report Adequate Feasibility of the THCR Intervention | This outcome assesses the proportion of participants in the THCR arm who report an average score ≥4 on the Feasibility of Intervention Measure (FIM), a 4-item scale evaluating patient-perceived feasibility of the intervention. Each item is rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). Individual item scores are summed (possible range: 4 to 20) and averaged (possible range: 1 to 5). Participants with a mean score ≥4 ("agree" or "strongly agree" on average) are considered to perceive the intervention as adequately feasible. Higher scores indicate greater feasibility. | Posted | Number | Proportion of participants | At study completion (approximately 12 weeks) |
|
|
|
|
| Other Pre-specified | Change in Total Distance Traveled in 6MWT | This is to measure pre-to-post program change in functional capacity (using the six-minute walk test [6MWT]) among THCR and, separately, traditional CR participants. The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The total distance (meters) traveled over a time period of six minutes is used as the outcome by which to compare changes in performance capacity. | Excludes one Traditional CR participant who moved out of state and did not complete the post-program 6MWT. | Posted | Mean | Standard Error | distance traveled (meters) | Baseline and 3-month post program completion (Week 12) |
|
|
|
| Other Pre-specified | Change in Health-related Quality of Life Score | This is to measure pre-to-post program change in health-related quality of life (Duke health profile questionnaire [DUKE; physical, mental, social, and general health composite scores]) among THCR and, separately, traditional CR participants (composite score). The DUKE is a 17-item self-report questionnaire for measuring generic health-related quality of life over a 1-week time period. Responses are scored to calculate physical health, mental health, and social health scores, which are then summed and divided by 3 to obtain a general health score. The general health score ranges from 0 - 100, with high scores indicating better health-related quality of life. | Excludes two Traditional CR participants: one who moved out of state and did not complete the post-program in-clinic assessments, and one who did not complete the post-program HRQOL assessment. | Posted | Mean | Standard Error | score on a scale | Baseline and 3-month post program completion (Week 12) |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 1 |
| 5 |
| EG001 | Traditional CR | Participants will receive a standard of care version of cardiac rehabilitation. | 0 | 5 | 0 | 5 | 0 | 5 |
Not provided
Not provided
Not provided
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| Proportion |
| 1.0 |
| 1-Sided |
| 95 |
| 0.55 |
The estimate is based on the proportion of participants in the Traditional CR arm who attended at least one cardiac rehabilitation session after randomization. A 1-sided 95% lower confidence limit was computed. |
| Other |