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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05933083
• Other study ID #: IHS-2021C3-24147
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2023
• Est. completion date: October 15, 2027

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: Alisa Boyd, MPH
• Phone: 415-502-6191
• Email: mcnairstudy[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 516
• Est. completion date: October 15, 2027
• Est. primary completion date: October 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%)

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

Related Conditions & MeSH terms

• Angina, Stable
• Coronary Artery Disease
• Heart Failure, Systolic
• Heart Transplant
• Heart Valve Diseases
• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• In-person cardiac rehabilitation
In-person exercise training, health education, and counseling
• Telehealth cardiac rehabilitation
Telehealth exercise training, health education, and counseling

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University Medical Center	Baltimore	Maryland
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of California, San Francisco	San Francisco	California

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood pressure control	Blood pressure less than 130/80 mmHg	12 months
Secondary	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
Secondary	Survival free of hospitalization for myocardial infarction, heart failure, or stroke/TIA.		24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood pressure control	Blood pressure less than 130/80 mmHg	3 months
Secondary	Blood pressure control	Blood pressure less than 130/80 mmHg	24 months