Angina, Stable, Coronary Artery Disease, Heart Failure, Systolic, Heart Transplant, Heart Valve Diseases, Myocardial Infarction
Conditions
Keywords
cardiac rehabilitation, telehealth
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.
Interventions
BEHAVIORALIn-person cardiac rehabilitation
In-person exercise training, health education, and counseling
BEHAVIORALTelehealth cardiac rehabilitation
Telehealth exercise training, health education, and counseling
Sponsors
University of California, San Francisco
Patient-Centered Outcomes Research Institute
Mayo Clinic
University of Michigan
University of Pittsburgh
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in six minute walk distance | Baseline and 12 months | The distance walked in six minute on a standard course will be measured in meters at baseline and 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival free of hospitalization for myocardial infarction, heart failure, or stroke/TIA. | 24 months | — |
| Change in PROMIS Global Health 10 Scores - Mental Health | Baseline and 3 months | 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 GAD-7 | Baseline and 3 months | 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 PHQ-9 | 3 months | 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 Patient Health Questionnaire (PHQ)-9 | Baseline and 12 months | 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. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 Scores - Mental Health | Baseline and 12 months | 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 | Baseline and 12 months | 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 | Baseline and 12 months | 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. |
| Participation in cardiac rehabilitation | 12 months | Participation in CR, defined as proportion of core sessions attended (out of 36 sessions for in-person and 12 sessions for telehealth) |
| Blood pressure control | 12 months | Blood pressure less than 130/80 mmHg |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlexis Beatty, MD, MAS
University of California, San Francisco
Outcome results
None listed