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

NCT05933083 | Recruiting DMC

• 1 other identifier: IHS-2021C3-24147
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

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

Keywords

cardiac rehabilitation, telehealth

Outcome Measures

Primary Outcomes (1)

• Change in six minute walk distance

  The distance walked in six minute on a standard course will be measured in meters at baseline and 12 months.

  Baseline and 12 months

Secondary Outcomes (17)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 Scores - Mental Health

  Baseline and 12 months

• Change in PROMIS Global Health 10 Scores - Physical Health

  Baseline and 12 months

• Change in Generalized Anxiety Disorder (GAD)-7

  Baseline and 12 months

• Change in Patient Health Questionnaire (PHQ)-9

  Baseline and 12 months

• Blood pressure control

  12 months

Study Arms (2)

In-person cardiac rehabilitation

ACTIVE COMPARATOR

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.

Behavioral: In-person cardiac rehabilitation

Telehealth cardiac rehabilitation

ACTIVE COMPARATOR

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.

Behavioral: Telehealth cardiac rehabilitation

Interventions

In-person cardiac rehabilitation BEHAVIORAL

In-person exercise training, health education, and counseling

In-person cardiac rehabilitation

Telehealth cardiac rehabilitation BEHAVIORAL

Telehealth exercise training, health education, and counseling

Telehealth cardiac rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Eligible for cardiac rehabilitation
• Diagnosis within 1 year prior to consent
• Myocardial infarction
• Percutaneous coronary intervention
• Coronary artery bypass
• Heart valve repair or replacement
• Heart transplant
• Chronic stable angina, or
• Chronic systolic heart failure (ejection fraction ≤ 35%)
• 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.
• Willing to be randomized to in-person or telehealth cardiac rehabilitation
• Able to communicate in English or Spanish

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Mayo Clinic: collaborator
• University of Michigan: collaborator
• University of Pittsburgh: collaborator
• Johns Hopkins University: collaborator

Study Sites (5)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Denver Health

Denver, Colorado, 80204, United States

RECRUITING

Johns Hopkins University Medical Center

Baltimore, Maryland, 21287, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48105, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Heart Failure; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Alexis Beatty, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alisa Boyd, MPH

CONTACT

415-502-6191; mcnairstudy@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 6, 2023
• Study Start: October 27, 2023
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (5)