Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors

Last updated: October 7, 2025
Sponsor: Columbia University
Overall Status: Completed

Phase

N/A

Condition

Circulation Disorders

Coronary Artery Disease

Hypercholesterolemia

Treatment

Telehealth-enhanced Hybrid CR

Traditional CR

Clinical Study ID

NCT05328375
AAAT7922 - pilot
KL2TR001874
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. over the age of 18;

  2. can speak and read English or Spanish;

  3. confirmed ACS based on ICD-10 codes; and

  4. had their index event within the past 12 months.

Exclusion

Exclusion Criteria:

  1. severe disabling chronic medical and/or psychiatric comorbidities determined on acase-by-case basis that prevent safe or adequate participation;

  2. high-risk for adverse exercise-related cardiovascular events according to the AACVPRrisk stratification criteria;

  3. participated in >1 CR program session;

  4. deemed unable to comply with the protocol (either self-selected or indicated duringscreening that s/he could not complete all requested tasks). This includes, but isnot limited to, patients with a level of cognitive impairment indicative ofdementia, patients with current alcohol or substance abuse, patients with asignificant movement or balance disorder that interferes with walking, patients withimpaired circulation or poor perfusion that may impede pulse oximeter readings, andpatients with severe mental illness (e.g., schizophrenia);

  5. home-based environment deemed incompatible with the protocol and/or that preventsafe or adequate participation (either self-selected or indicated duringscreening/onboarding process); and

  6. unavailable for follow-up for reasons such as terminal illness and imminent plans toleave the United States (as we have migrant or mobile patients due to theircitizenship and work issues).

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Telehealth-enhanced Hybrid CR
Phase:
Study Start date:
March 11, 2022
Estimated Completion Date:
May 01, 2023

Study Description

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.

Connect with a study center

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

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