The Heart Health After Cardiac Treatment Study (HEART-ACT)

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 Overview

• Status: Recruiting
• Conditions: Cardiac Rehabilitation
• Intervention / Treatment: Behavioral: Tailored cardiac rehabilitation; Behavioral: Referral to an external cardiac rehabilitation program

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alisa Boyd, MPH; Phone Number: 415-514-7905; Email: heartact@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Recruiting
      • Zuckerberg San Francisco General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tailored cardiac rehabilitation in a safety net setting; A 12-week program of exercise training and health behavior counseling consisting of every other week group sessions (exercise and health behavior education) and every other week individual counseling sessions that address the cardiac rehabilitation core components.	Behavioral: Tailored 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.
Active Comparator: Referral to an outside cardiac rehabilitation program; Referral to a cardiac rehabilitation program outside of the safety net hospital setting.	Behavioral: Referral 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in six-minute walk distance	Change in distance walked in 6 minutes, following a standard protocol, from baseline to 12 months.	12 months
Change in six-minute walk distance	Change in distance walked in 6 minutes, following a standard protocol, from baseline to 3 months.	3 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.	12 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.	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.	3 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: 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)
• Investigators: Principal Investigator: Alexis Beatty, MD, MAS, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 28, 2025
• First Submitted That Met QC Criteria: August 28, 2025
• First Posted (Estimated): September 5, 2025

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: comparative effectiveness; safety net
• Other Study ID Numbers: 23-40216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At the conclusion of the study, we will follow local procedures and laws regarding the sharing of individual participant data. Any data that are shared will be de-identified prior to sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No