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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Behavioral: In-person cardiac rehabilitation
* Behavioral: Telehealth cardiac rehabilitation


Participation Criteria
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Eligibility Criteria
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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%) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-person cardiac rehabilitation<br>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<br>* In-person exercise training, health education, and counseling<br>|
| Active Comparator: Telehealth cardiac rehabilitation<br>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<br>* Telehealth exercise training, health education, and counseling<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac rehabilitation, telehealth