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

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05933083
• Collaborator: Patient-Centered Outcomes Research Institute (Other), Mayo Clinic (Other), University of Michigan (Other), University of Pittsburgh (Other), Johns Hopkins University (Other)
• Enrollment: 516
• Locations: 4
• Arms: 2
• Anticipated Duration (Months): 51
• Patients Per Site: 129
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction; Heart Failure, Systolic; Heart Valve Diseases; Angina, Stable; Coronary Artery Disease; Heart Transplant	Behavioral: In-person cardiac rehabilitation; Behavioral: Telehealth cardiac rehabilitation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 516 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation
• Anticipated Study Start Date: Jul 17, 2023
• Anticipated Primary Completion Date: Oct 15, 2026
• Anticipated Study Completion Date: Oct 15, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Change in PROMIS Global Health 10 Scores - Physical 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. 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 [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 [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 [12 months]

   Blood pressure less than 130/80 mmHg

6. 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)

7. Survival free of hospitalization for myocardial infarction, heart failure, or stroke/TIA. [24 months]

8. Change in PROMIS Global Health 10 Scores - Mental Health [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 [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 [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 [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 [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 [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 [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 [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 [3 months]

    Blood pressure less than 130/80 mmHg

17. Blood pressure control [24 months]

    Blood pressure less than 130/80 mmHg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age 18 or older

2. Eligible for cardiac rehabilitation

3. Diagnosis within 1 year prior to consent

• Myocardial infarction

• Percutaneous coronary intervention

• Coronary artery bypass

• Heart valve repair or replacement

• Heart transplant

1. Chronic stable angina, or

2. Chronic systolic heart failure (ejection fraction ≤ 35%)

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143
2	Johns Hopkins University Medical Center	Baltimore	Maryland	United States	21287
3	University of Michigan	Ann Arbor	Michigan	United States	48105
4	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15232

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Alexis Beatty, MD, MAS, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT05933083
• Other Study ID Numbers: IHS-2021C3-24147
• First Posted: Jul 6, 2023
• Last Update Posted: Jul 6, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of California, San Francisco: cardiac rehabilitation, telehealth
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Infarction; Heart Valve Diseases; Heart Failure, Systolic; Angina, Stable; Infarction

Study Results

No Results Posted as of Jul 6, 2023