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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 516
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alisa Boyd, MPH; Phone Number: 415-502-6191; Email: mcnairstudy@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Alisa Boyd, MPH; Phone Number: 415-502-6191; Email: mcnairstudy@ucsf.edu
      • Principal Investigator: Alexis Beatty, MD
  • Colorado
    • Denver, Colorado, United States, 80204
      • Recruiting
      • Denver Health
      • Contact: Tanner Bryan; Phone Number: 303-602-2880; Email: MCNAIRDenverHealth@dhha.org
      • Principal Investigator: Pamela Douglas, MD
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University Medical Center
      • Principal Investigator: Seth Martin, MD
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Recruiting
      • University of Michigan
      • Principal Investigator: Brahmajee Nallamothu, MD
      • Sub-Investigator: Jessica Golbus, MD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • University of Pittsburgh Medical Center
      • Principal Investigator: Daniel Forman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: In-person cardiac rehabilitation; In-person exercise training, health education, and counseling
Active Comparator: 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.	Behavioral: Telehealth cardiac rehabilitation; Telehealth exercise training, health education, and counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 Scores - Mental Health	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	Baseline and 12 months
Change in PROMIS Global Health 10 Scores - Physical Health	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. 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.	Baseline and 12 months
Change in Generalized Anxiety Disorder (GAD)-7	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.	Baseline and 12 months
Change in Patient Health Questionnaire (PHQ)-9	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.	Baseline and 12 months
Blood pressure control	Blood pressure less than 130/80 mmHg	12 months
Participation in cardiac rehabilitation	Participation in CR, defined as proportion of core sessions attended (out of 36 sessions for in-person and 12 sessions for telehealth)	12 months
Survival free of hospitalization for myocardial infarction, heart failure, or stroke/TIA.		24 months
Change in PROMIS Global Health 10 Scores - Mental Health	A change in PROMIS Global Health 10 scores will be measured during the first 3 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.	Baseline and 3 months
Change in PROMIS Global Health 10 Scores - Mental Health	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.	Baseline and 24 months
Change in PROMIS Global Health 10 Scores - Physical Health	A change in PROMIS Global Health 10 scores will be measured during the first 3 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.	Baseline and 3 months
Change in PROMIS Global Health 10 Scores - Physical Health	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.	Baseline and 24 months
Change in GAD-7	A change in GAD-7 scores will be measured during the first 3 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.	Baseline and 3 months
Change in GAD-7	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.	Baseline and 24 months
Change in PHQ-9	A change in PHQ-9 scores will be measured during the first 3 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.	3 months
Change in PHQ-9	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.	24 months
Blood pressure control	Blood pressure less than 130/80 mmHg	3 months
Blood pressure control	Blood pressure less than 130/80 mmHg	24 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Patient-Centered Outcomes Research Institute; Johns Hopkins University; Mayo Clinic; University of Pittsburgh; University of Michigan
• Investigators: Principal Investigator: Alexis Beatty, MD, MAS, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2023
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2027

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: cardiac rehabilitation, telehealth
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Ischemia; Chest Pain; Angina Pectoris; Heart Failure; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Coronary Artery Disease; Myocardial Infarction; Angina, Stable; Heart Valve Diseases; Heart Failure, Systolic
• Other Study ID Numbers: IHS-2021C3-24147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After study completion, the investigators will generate a de-identified dataset that may be shared with other researchers upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No