Clinical trial NCT05933083: 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
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Heart Failure, Systolic
Heart Valve Diseases
Angina, Stable
Coronary Artery Disease
Heart Transplant
Keywords: cardiac rehabilitation, telehealth
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Mayo Clinic
name: University of Michigan
name: University of Pittsburgh
name: Johns Hopkins University
First posted: 2023-07-06
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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%)
   4. 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.
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

Primary outcomes:
measure: Change in six minute walk distance
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 Scores - Mental Health
timeFrame: Baseline and 12 months
measure: Change in PROMIS Global Health 10 Scores - Physical Health
timeFrame: Baseline and 12 months
measure: Change in Generalized Anxiety Disorder (GAD)-7
timeFrame: Baseline and 12 months
measure: Change in Patient Health Questionnaire (PHQ)-9
timeFrame: Baseline and 12 months
measure: Blood pressure control
timeFrame: 12 months
measure: Participation in cardiac rehabilitation
timeFrame: 12 months
measure: Survival free of hospitalization for myocardial infarction, heart failure, or stroke/TIA.
timeFrame: 24 months
measure: Change in PROMIS Global Health 10 Scores - Mental Health
timeFrame: Baseline and 3 months
measure: Change in PROMIS Global Health 10 Scores - Mental Health
timeFrame: Baseline and 24 months
measure: Change in PROMIS Global Health 10 Scores - Physical Health
timeFrame: Baseline and 3 months
measure: Change in PROMIS Global Health 10 Scores - Physical Health
timeFrame: Baseline and 24 months
measure: Change in GAD-7
timeFrame: Baseline and 3 months
measure: Change in GAD-7
timeFrame: Baseline and 24 months
measure: Change in PHQ-9
timeFrame: 3 months
measure: Change in PHQ-9
timeFrame: 24 months
measure: Blood pressure control
timeFrame: 3 months
measure: Blood pressure control
timeFrame: 24 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University Medical Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of California, San Francisco
name: Alexis Beatty, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: