Cardiac Rehabilitation
Conditions
Keywords
comparative effectiveness, safety net
Brief summary
The goal of this study is to determine whether participation in a tailored cardiac rehabilitation program delivered in a safety net setting, compared to usual care referral to an outside cardiac rehabilitation program, results in greater participation in cardiac rehabilitation.
Interventions
BEHAVIORALTailored cardiac rehabilitation
The program will address the core components of CR.21 Each of the program components will have an individualized assessment with plan and goals set at the program intake visit. The 12-week program will alternate between group and individual sessions each week. Individualized plans will be reviewed every two weeks at the participant individual sessions. Group sessions will address physical activity, nutrition, and other program topics. Duration of the program was chosen to resemble a typical 12-week cardiac rehabilitation intervention. However, the program will have a greater emphasis on cultural tailoring, language concordance, lowering burden of real-time in-person attendance, motivational coaching, and addressing psychosocial needs.
BEHAVIORALReferral to an external cardiac rehabilitation program
Participants will be referred to an external cardiac rehabilitation program outside of the safety net setting. This is the current standard of care.
Sponsors
University of California, San Francisco
This work was made possible by residual class settlement funds in the matter of April Krueger v. Wyeth, Inc., Case No. 03-cv-2496 (US District Court, SD of CA)
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+ 2. Referred for cardiac rehabilitation for a covered indication: 1. Acute myocardial infarction 2. Percutaneous coronary intervention 3. Coronary artery bypass surgery 4. Heart valve repair or replacement 5. Heart transplant 6. Chronic stable angina 7. Chronic systolic heart failure (EF \<=35%) 3. Able to communicate in English, Spanish, or Cantonese 4. Able to consent for self
Exclusion criteria
1. Currently enrolled in hospice. 2. Provider says patient may not be approached for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participation in at least 1 session of cardiac rehabilitation | 12 months | In each arm, the proportion of participants who attended at least 1 cardiac rehabilitation session will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion of cardiac rehabilitation | 12 months | In each arm, the proportion of participants who attend at least 2/3 of expected sessions of cardiac rehabilitation (24 sessions in the active comparator arm and 8 sessions in the experimental arm) will be calculated. |
| Change in six-minute walk distance | 12 months | Change in distance walked in 6 minutes, following a standard protocol, from baseline to 12 months. |
| Change in quality of life | 12 months | Change in PROMIS Global Health physical and mental subscores between baseline and 12 months. The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The physical and mental health subscales each consist 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlexis Beatty, MD, MAS
University of California, San Francisco
Outcome results
None listed