Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Acute Coronary Syndrome, Myocardial Infarction

Intervention / Treatment
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* Behavioral: Telehealth-enhanced Hybrid CR
* Behavioral: Traditional CR


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth-enhanced Hybrid CR<br>Participants will receive a hybrid version of cardiac rehabilitation. | Behavioral: Telehealth-enhanced Hybrid CR<br>* 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.<br>|
| Active Comparator: Traditional CR<br>Participants will receive a standard of care version of cardiac rehabilitation. | Behavioral: Traditional CR<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 successfully consented and enrolled into the pilot study per month. | Assessed during recruitment and until after enrollment (baseline) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants that attend ≥1 CR session after randomization in each arm | 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. | During 12-week follow-up period (Up to 12 weeks) | 
| Mean proportion of CR sessions completed by those allocated to the traditional CR intervention | 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. | Assessed after enrollment (baseline) and until pilot study completion (approximately 12 weeks) | 
| Proportion of participants who report adequate feasibility of the THCR intervention | 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. | At study completion (approximately 12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, Myocardial Infarction, Cardiac Rehabilitation, Feasibility, Adherence