Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors

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

Interventions

BEHAVIORAL

Telehealth-enhanced Hybrid CR

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.

BEHAVIORAL

Traditional CR

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.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Andrea T Duran, PhD · Columbia University

• Daichi Shimbo, MD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-11

Primary Completion

2023-04-26

Completion

2023-05-01

Countries

• United States

Study Locations