Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors

February 5, 2024 updated by: Andrea Duran, Columbia University

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who are successfully enrolled into the pilot study per month
Time Frame: 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.
Assessed during recruitment and until after enrollment (baseline)
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.
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
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 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
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.
Assessed after enrollment (baseline) and until pilot study completion (approximately 12 weeks)
Proportion of participants who report adequate feasibility of the THCR intervention
Time Frame: 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.
At study completion (approximately 12 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total distance traveled in 6MWT
Time Frame: Baseline and 3-month post program completion
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.
Baseline and 3-month post program completion
Change in health-related quality of life score
Time Frame: Baseline and 3-month post program completion
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. 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.
Baseline and 3-month post program completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

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

Investigators

  • Principal Investigator: Andrea T Duran, PhD, Columbia University
  • Study Director: Daichi Shimbo, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 1, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAT7922
  • KL2TR001874 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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