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Completed

NCT Number: NCT05328375

Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of Participants Who Are Successfully Enrolled Into the Pilot Study Per Month

    Time frame: During enrollment, 11 months

    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.

  2. Mean Proportion of CR Sessions Completed by Participants Allocated to the THCR Intervention

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

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

  3. Proportion of Participants Who Report Adequate Feasibility of the THCR Intervention

    Time frame: At study completion (approximately 12 weeks)

    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.

Other outcomes

  1. Change in Total Distance Traveled in 6MWT

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

    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.

  2. Change in Health-related Quality of Life Score

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

    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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institutes of Health (NIH)

Registry information

Official study title

Implementing Telehealth-enhanced Hybrid Cardiac Rehabilitation (THCR) Among Acute Coronary Syndrome Survivors: A Pilot Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2022
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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