Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome; Myocardial Infarction
• Interventions: Behavioral: Traditional CR; Behavioral: Telehealth-enhanced Hybrid CR

• Registration Number: NCT05328375
• Lead Sponsor: Columbia University

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.

Detailed 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.

Study Timeline

• Study Start: 2022-03-11
• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Primary Completion: 2023-04-26
• Study Completion: 2023-05-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 Criteria

1. severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevent safe or adequate participation;
2. high-risk for adverse exercise-related cardiovascular events according to the AACVPR risk stratification criteria;
3. participated in >1 CR program session;
4. 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);
5. 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
6. 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional CR	Traditional CR	Participants will receive a standard of care version of cardiac rehabilitation.
Telehealth-enhanced Hybrid CR	Telehealth-enhanced Hybrid CR	Participants will receive a hybrid version of cardiac rehabilitation.

Primary Outcome Measures

Name	Time	Method
Number of participants who are successfully enrolled into the pilot study per month	Assessed during recruitment and until after enrollment (baseline)	As a measure of enrollment feasibility, the investigator will assess the number of participants who completed recruitment activities and successfully consented and enrolled into the pilot study per month.
Mean proportion of CR sessions completed by participants allocated to the THCR intervention	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 Outcome Measures

Name	Time	Method
Proportion of participants that attend ≥1 CR session after randomization in each arm	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 more than 1 CR session. Denominator = total number of participants randomized into each arm.
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)	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.
Proportion of participants who report adequate feasibility of the THCR intervention	At study completion (approximately 12 weeks)	The investigator will assess the proportion of participants who report an average score ≥4 (agree or completely agree) for their rating of the patient-perceived THCR intervention's feasibility on the four-item Feasibility of Intervention Measure (FIM). All four items of the FIM are rated on a Likert response scale ranging from 1 to 5 with higher scores indicating greater feasibility. Each Likert response scale rating will be summed (minimum: 4, maximum: 20) and averaged (minimum: 1, maximum: 5) across all four items.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States