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

Not Applicable

Recruiting

• Conditions: Heart Failure, Systolic; Coronary Artery Disease; Heart Valve Diseases; Angina, Stable; Myocardial Infarction; Heart Transplant
• Interventions: Behavioral: In-person cardiac rehabilitation; Behavioral: Telehealth cardiac rehabilitation

• Registration Number: NCT05933083
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-07-06
• Study Start: 2023-10-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-10-15
• Study Completion: 2027-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 516

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-person cardiac rehabilitation	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.
Telehealth cardiac rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Change in six minute walk distance	Baseline and 12 months	The distance walked in six minute on a standard course will be measured in meters at baseline and 12 months.

Secondary Outcome Measures

Name	Time	Method
Change in PROMIS Global Health 10 Scores - Physical Health	Baseline and 24 months	A change in PROMIS Global Health 10 scores will be measured during the first 24 months of the study. The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The physical health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better physical health.
Change in PHQ-9	24 months	A change in PHQ-9 scores will be measured during the first 24 months of the study. The PHQ-7 questionnaire is a self-assessed questionnaire that asks participants to respond to 9 questions with response option scores ranging from 0 to 3. The scale ranges from 0 to 27. Higher scores represent more depressive symptoms.
Change in Patient Health Questionnaire (PHQ)-9	Baseline and 12 months	A change in PHQ-9 scores will be measured during the first 12 months of the study. The PHQ-7 questionnaire is a self-assessed questionnaire that asks participants to respond to 9 questions with response option scores ranging from 0 to 3. The scale ranges from 0 to 27. Higher scores represent more depressive symptoms.
Change in PROMIS Global Health 10 Scores - Mental Health	Baseline and 24 months	A change in PROMIS Global Health 10 scores will be measured during the first 24 months of the study. The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions . The mental health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better mental health.
Blood pressure control	24 months	Blood pressure less than 130/80 mmHg
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 Scores - Mental Health	Baseline and 12 months	A change in PROMIS Global Health 10 scores will be measured during the first 12 months of the study. The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions with a 5-point ordinal rating scale of "Never," "Rarely," "Sometimes," "Often," and
Change in Generalized Anxiety Disorder (GAD)-7	Baseline and 12 months	A change in GAD-7 scores will be measured during the first 12 months of the study. The GAD-7 questionnaire is a self-assessed questionnaire that asks participants to respond to 7 questions with response option scores ranging from 0 to 3. The scale ranges from 0 to 21. Higher scores represent more anxiety symptoms.
Participation in cardiac rehabilitation	12 months	Participation in CR, defined as proportion of core sessions attended (out of 36 sessions for in-person and 12 sessions for telehealth)
Survival free of hospitalization for myocardial infarction, heart failure, or stroke/TIA.	24 months
Change in GAD-7	Baseline and 24 months	A change in GAD-7 scores will be measured during the first 24 months of the study. The GAD-7 questionnaire is a self-assessed questionnaire that asks participants to respond to 7 questions with response option scores ranging from 0 to 3. The scale ranges from 0 to 21. Higher scores represent more anxiety symptoms.

Trial Locations

Locations (4)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Johns Hopkins University Medical Center; 🇺🇸 Baltimore, Maryland, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States