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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Mayo Clinic | OTHER |
| University of Michigan | OTHER |
| University of Pittsburgh |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-person cardiac rehabilitation | Active Comparator | 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. |
|
| Telehealth cardiac rehabilitation | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-person cardiac rehabilitation | Behavioral | In-person exercise training, health education, and counseling |
|
| 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 |
| 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 |
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Inclusion Criteria:
Age 18 or older
Eligible for cardiac rehabilitation
Diagnosis within 1 year prior to consent
Chronic stable angina, or
Chronic systolic heart failure (ejection fraction ≤ 35%)
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.
Willing to be randomized to in-person or telehealth cardiac rehabilitation
Able to communicate in English or Spanish
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alisa Boyd, MPH | Contact | 415-502-6191 | mcnairstudy@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alexis Beatty, MD, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
After study completion, the investigators will generate a de-identified dataset that may be shared with other researchers upon request.
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| OTHER |
| Johns Hopkins University | OTHER |
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| Telehealth cardiac rehabilitation | Behavioral | Telehealth exercise training, health education, and counseling |
|
| 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 |
| Denver Health | Recruiting | Denver | Colorado | 80204 | United States |
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| Johns Hopkins University Medical Center | Recruiting | Baltimore | Maryland | 21287 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48105 | United States |
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| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D054143 | Heart Failure, Systolic |
| D006349 | Heart Valve Diseases |
| D060050 | Angina, Stable |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006333 | Heart Failure |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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