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

University of California San Francisco (UCSF)

Status: Enrolling

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

Treatments: Behavioral: Telehealth cardiac rehabilitation; Behavioral: In-person cardiac rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05933083

IHS-2021C3-24147

Details and patient eligibility

About

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.

Enrollment: 516 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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516 participants in 2 patient groups

In-person cardiac rehabilitation

Active Comparator group

Description:

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.

Treatment:

Behavioral: In-person cardiac rehabilitation

Telehealth cardiac rehabilitation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Telehealth cardiac rehabilitation