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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Participants will be referred to an external cardiac rehabilitation program outside of the safety net setting. This is the current standard of care.
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
Participation in at least 1 session of cardiac rehabilitation
In each arm, the proportion of participants who attended at least 1 cardiac rehabilitation session will be calculated.
Time frame: 12 months
Completion of cardiac rehabilitation
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.
Time frame: 12 months
Change in six-minute walk distance
Change in distance walked in 6 minutes, following a standard protocol, from baseline to 12 months.
Time frame: 12 months
Change in six-minute walk distance
Change in distance walked in 6 minutes, following a standard protocol, from baseline to 3 months.
Time frame: 3 months
Change in quality of life
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.
Time frame: 12 months
Change in quality of life
Change in PROMIS Global Health physical and mental subscores between baseline and 3 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.
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Time frame: 3 months