Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors

NCT05328375 | Completed Results

• 2 other identifiers: AAAT7922 - pilotKL2TR001874
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Keywords

Acute Coronary Syndrome; Myocardial Infarction; Cardiac Rehabilitation; Feasibility; Adherence

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (3)

• Proportion of Participants That Attend ≥1 CR Session After Randomization in Each Arm

  During 12-week follow-up period (Up to 12 weeks)

• Mean Proportion of CR Sessions Completed by Those Allocated to the Traditional CR Intervention

  Assessed after enrollment (baseline) and until pilot study completion (approximately 12 weeks)

• Proportion of Participants Who Report Adequate Feasibility of the THCR Intervention

  At study completion (approximately 12 weeks)

Other Outcomes (2)

• Change in Total Distance Traveled in 6MWT

  Baseline and 3-month post program completion (Week 12)

• Change in Health-related Quality of Life Score

  Baseline and 3-month post program completion (Week 12)

Study Arms (2)

Telehealth-enhanced Hybrid CR

EXPERIMENTAL

Participants will receive a hybrid version of cardiac rehabilitation.

Behavioral: Telehealth-enhanced Hybrid CR

Traditional CR

ACTIVE COMPARATOR

Participants will receive a standard of care version of cardiac rehabilitation.

Behavioral: Traditional CR

Interventions

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.

Telehealth-enhanced Hybrid CR

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.

Traditional CR

Eligibility Criteria

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

You may qualify if:

• over the age of 18;
• can speak and read English or Spanish;
• confirmed ACS based on ICD-10 codes; and
• had their index event within the past 12 months.

You may not qualify if:

• severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevent safe or adequate participation;
• high-risk for adverse exercise-related cardiovascular events according to the AACVPR risk stratification criteria;
• participated in \>1 CR program session;
• deemed unable to comply with the protocol (either self-selected or indicated during screening that s/he could not complete all requested tasks). This includes, but is not limited to, patients with a level of cognitive impairment indicative of dementia, patients with current alcohol or substance abuse, patients with a significant movement or balance disorder that interferes with walking, patients with impaired circulation or poor perfusion that may impede pulse oximeter readings, and patients with severe mental illness (e.g., schizophrenia);
• home-based environment deemed incompatible with the protocol and/or that prevent safe or adequate participation (either self-selected or indicated during screening/onboarding process); and
• unavailable for follow-up for reasons such as terminal illness and imminent plans to leave the United States (as we have migrant or mobile patients due to their citizenship and work issues).

Sponsors & Collaborators

• Columbia University: lead
• National Institutes of Health (NIH): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (5)

• 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.

  PMID: 31931615 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.

  PMID: 31082266 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.

  PMID: 25249585 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.

  PMID: 22052934 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.

  PMID: 31423874 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Andrea T. Duran, Assistant Professor of Medical Sciences
• Organization: Columbia University Irving Medical Center

atd2127@cumc.columbia.edu

212.342.4491

Study Officials

• Andrea T Duran, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Daichi Shimbo, MD

  Columbia University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in the Department of Medicine

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 14, 2022
• Study Start: March 11, 2022
• Primary Completion: April 26, 2023
• Study Completion: May 1, 2023
• Last Updated: October 22, 2025
• Results First Posted: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)