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NCT Number: NCT05933083

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

In-person cardiac rehabilitation

Behavioral

In-person exercise training, health education, and counseling

Telehealth cardiac rehabilitation

Behavioral

Telehealth exercise training, health education, and counseling

Primary outcomes

  1. Change in six minute walk distance

    Time frame: 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 outcomes

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

    Time frame: 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

  2. Change in PROMIS Global Health 10 Scores - Physical Health

    Time frame: 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. 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.

  3. Change in Generalized Anxiety Disorder (GAD)-7

    Time frame: 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.

  4. Change in Patient Health Questionnaire (PHQ)-9

    Time frame: 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.

  5. Blood pressure control

    Time frame: 12 months

    Blood pressure less than 130/80 mmHg

  6. Participation in cardiac rehabilitation

    Time frame: 12 months

    Participation in CR, defined as proportion of core sessions attended (out of 36 sessions for in-person and 12 sessions for telehealth)

  7. Survival free of hospitalization for myocardial infarction, heart failure, or stroke/TIA.

    Time frame: 24 months

  8. Change in PROMIS Global Health 10 Scores - Mental Health

    Time frame: Baseline and 3 months

    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.

  9. Change in PROMIS Global Health 10 Scores - Mental Health

    Time frame: 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.

  10. Change in PROMIS Global Health 10 Scores - Physical Health

    Time frame: Baseline and 3 months

    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.

  11. Change in PROMIS Global Health 10 Scores - Physical Health

    Time frame: 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.

  12. Change in GAD-7

    Time frame: Baseline and 3 months

    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.

  13. Change in GAD-7

    Time frame: 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.

  14. Change in PHQ-9

    Time frame: 3 months

    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.

  15. Change in PHQ-9

    Time frame: 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.

  16. Blood pressure control

    Time frame: 3 months

    Blood pressure less than 130/80 mmHg

  17. Blood pressure control

    Time frame: 24 months

    Blood pressure less than 130/80 mmHg

Study contacts

Contact information is provided by the study sponsor or research team.

Alisa Boyd, MPH

CONTACT

[email protected]

415-502-6191

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Johns Hopkins University
  • Mayo Clinic
  • Patient-Centered Outcomes Research Institute
  • University of Michigan
  • University of Pittsburgh

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 6, 2023
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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