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The Heart Health After Cardiac Treatment Study

ConditionCardiac Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18+

Acute myocardial infarction

Percutaneous coronary intervention

Coronary artery bypass surgery

Disqualifiers

Currently enrolled in hospice.

Provider says patient may not be approached for participation in this study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tailored cardiac rehabilitation

    Behavioral

    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.

  • Referral to an external cardiac rehabilitation program

    Behavioral

    Participants will be referred to an external cardiac rehabilitation program outside of the safety net setting. This is the current standard of care.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Tailored cardiac rehabilitation in a safety net settingExperimental treatment 1 intervention
Group B: Referral to an outside cardiac rehabilitation programActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

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)

Collaborator

Source ClinicalTrials.gov
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