MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation

NCT ID: NCT05933083

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

516 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-27

Study Completion Date

2027-10-15

Brief Summary

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Cardiac rehabilitation is a medically recommended program for patients with certain heart conditions. It includes exercise training, health education, and counseling. Unfortunately, many patients do not participate in cardiac rehabilitation. Some find it challenging to attend the in-person sessions. This study aims to compare two methods of delivering cardiac rehabilitation: in-person and through telehealth. The investigators want to know if the effects of these two programs are alike and if certain individuals benefit more from one program over the other.

Detailed Description

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Conditions

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Myocardial Infarction Heart Failure, Systolic Heart Valve Diseases Angina, Stable Coronary Artery Disease Heart Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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In-person cardiac rehabilitation

Participants will participate in 12-week in-person cardiac rehabilitation as delivered at the site where they are enrolled. The typical course is 36 sessions of group exercise, health education, and counseling over 12 weeks.

Group Type ACTIVE_COMPARATOR

In-person cardiac rehabilitation

Intervention Type BEHAVIORAL

In-person exercise training, health education, and counseling

Telehealth cardiac rehabilitation

Participants will participate in 12-week telehealth cardiac rehabilitation. The program will follow the same core components as in-person cardiac rehabilitation, but in-person supervised exercise will not be required. The core element of telehealth cardiac rehabilitation is 12 weekly individual telehealth sessions between the patient and cardiac rehabilitation provider.

Group Type ACTIVE_COMPARATOR

Telehealth cardiac rehabilitation

Intervention Type BEHAVIORAL

Telehealth exercise training, health education, and counseling

Interventions

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In-person cardiac rehabilitation

In-person exercise training, health education, and counseling

Intervention Type BEHAVIORAL

Telehealth cardiac rehabilitation

Telehealth exercise training, health education, and counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age 18 or older
2. Eligible for cardiac rehabilitation

1. Diagnosis within 1 year prior to consent

* Myocardial infarction
* Percutaneous coronary intervention
* Coronary artery bypass
* Heart valve repair or replacement
* Heart transplant
2. Chronic stable angina, or
3. Chronic systolic heart failure (ejection fraction ≤ 35%)
4. Referred to cardiac rehabilitation by a doctor or advanced practice provider for another indication that is covered by the participant's insurance, such as heart failure with preserved ejection fraction or aortic surgery.
3. Willing to be randomized to in-person or telehealth cardiac rehabilitation
4. Able to communicate in English or Spanish

Exclusion Criteria

1. Unstable arrhythmias which may make unmonitored exercise unsafe (e.g., history of ventricular tachycardia not on medical therapy and without an implantable cardioverter defibrillator)
2. Unsafe for patient to participate in the opinion of the investigator
3. Hospice
4. Unable to consent for self
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexis Beatty, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Denver Health

Denver, Colorado, United States

Site Status RECRUITING

Johns Hopkins University Medical Center

Baltimore, Maryland, United States

Site Status RECRUITING

University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alisa Boyd, MPH

Role: CONTACT

415-502-6191

Facility Contacts

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Alisa Boyd, MPH

Role: primary

415-502-6191

Tanner Bryan

Role: primary

303-602-2880

Other Identifiers

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IHS-2021C3-24147

Identifier Type: -

Identifier Source: org_study_id

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