Back to resultsMCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation
Primary Purpose
Myocardial Infarction, Heart Failure, Systolic, Heart Valve Diseases
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-person cardiac rehabilitation
Telehealth cardiac rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring cardiac rehabilitation, telehealth
Eligibility Criteria
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
Sites / Locations
- University of California, San Francisco
- Johns Hopkins University Medical Center
- University of Michigan
- University of Pittsburgh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
In-person cardiac rehabilitation
Telehealth cardiac rehabilitation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
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.
Blood pressure control
Blood pressure less than 130/80 mmHg
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)
Survival free of hospitalization for myocardial infarction, heart failure, or stroke/TIA.
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.
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.
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.
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.
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.
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.
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.
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.
Blood pressure control
Blood pressure less than 130/80 mmHg
Blood pressure control
Blood pressure less than 130/80 mmHg
Full Information
NCT ID
NCT05933083
First Posted
June 27, 2023
Last Updated
September 19, 2023
Sponsor
University of California, San Francisco
Collaborators
Patient-Centered Outcomes Research Institute, Mayo Clinic, University of Michigan, University of Pittsburgh, Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT05933083
Brief Title
MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation
Official Title
MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
October 15, 2026 (Anticipated)
Study Completion Date
October 15, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Patient-Centered Outcomes Research Institute, Mayo Clinic, University of Michigan, University of Pittsburgh, Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Heart Failure, Systolic, Heart Valve Diseases, Angina, Stable, Coronary Artery Disease, Heart Transplant
Keywords
cardiac rehabilitation, telehealth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
516 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
In-person cardiac rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Telehealth cardiac rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
In-person cardiac rehabilitation
Intervention Description
In-person exercise training, health education, and counseling
Intervention Type
Behavioral
Intervention Name(s)
Telehealth cardiac rehabilitation
Intervention Description
Telehealth exercise training, health education, and counseling
Primary Outcome Measure Information:
Title
Change in six minute walk distance
Description
The distance walked in six minute on a standard course will be measured in meters at baseline and 12 months.
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 Scores - Mental Health
Description
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
Time Frame
Baseline and 12 months
Title
Change in PROMIS Global Health 10 Scores - Physical Health
Description
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.
Time Frame
Baseline and 12 months
Title
Change in Generalized Anxiety Disorder (GAD)-7
Description
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.
Time Frame
Baseline and 12 months
Title
Change in Patient Health Questionnaire (PHQ)-9
Description
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.
Time Frame
Baseline and 12 months
Title
Blood pressure control
Description
Blood pressure less than 130/80 mmHg
Time Frame
12 months
Title
Participation in cardiac rehabilitation
Description
Participation in CR, defined as proportion of core sessions attended (out of 36 sessions for in-person and 12 sessions for telehealth)
Time Frame
12 months
Title
Survival free of hospitalization for myocardial infarction, heart failure, or stroke/TIA.
Time Frame
24 months
Title
Change in PROMIS Global Health 10 Scores - Mental Health
Description
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.
Time Frame
Baseline and 3 months
Title
Change in PROMIS Global Health 10 Scores - Mental Health
Description
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.
Time Frame
Baseline and 24 months
Title
Change in PROMIS Global Health 10 Scores - Physical Health
Description
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.
Time Frame
Baseline and 3 months
Title
Change in PROMIS Global Health 10 Scores - Physical Health
Description
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.
Time Frame
Baseline and 24 months
Title
Change in GAD-7
Description
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.
Time Frame
Baseline and 3 months
Title
Change in GAD-7
Description
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.
Time Frame
Baseline and 24 months
Title
Change in PHQ-9
Description
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.
Time Frame
3 months
Title
Change in PHQ-9
Description
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.
Time Frame
24 months
Title
Blood pressure control
Description
Blood pressure less than 130/80 mmHg
Time Frame
3 months
Title
Blood pressure control
Description
Blood pressure less than 130/80 mmHg
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alisa Boyd, MPH
Phone
415-502-6191
Email
mcnairstudy@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis Beatty, MD, MAS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alisa Boyd, MPH
Phone
415-502-6191
Email
mcnairstudy@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Alexis Beatty, MD
Facility Name
Johns Hopkins University Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seth Martin, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brahmajee Nallamothu, MD
First Name & Middle Initial & Last Name & Degree
Jessica Golbus, MD
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Forman, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After study completion, the investigators will generate a de-identified dataset that may be shared with other researchers upon request.
Learn more about this trial
MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation
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