About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 18 or older
Eligible for cardiac rehabilitation
Diagnosis within 1 year prior to consent
Myocardial infarction
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
In-person cardiac rehabilitation
BehavioralIn-person exercise training, health education, and counseling
Telehealth cardiac rehabilitation
BehavioralTelehealth exercise training, health education, and counseling
Treatment groups
Trial outcomes
Primary outcomes
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 outcomes
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.
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Mayo Clinic
Collaborator
University of Michigan
Collaborator
University of Pittsburgh
Collaborator
Johns Hopkins University
Collaborator