The Healthy Heart Study

NCT02105246 | Completed Results

• 1 other identifier: CHR13-10887
• Study Type: interventional
• Target: 1,154
• Locations: 1 country
• Sites: 1

Brief Summary

The long-term goal of this research is to improve patient-centered outcomes in patients with coronary heart disease (CHD), the leading cause of death in the world. Exercise-based cardiac rehabilitation (CR) programs decrease mortality and improve quality of life in patients with CHD. Published guidelines recommend exercise-based CR following hospitalization for myocardial infarction, coronary artery bypass grafting, or percutaneous coronary revascularization. Despite these compelling benefits, CR programs are vastly underutilized, with less than a third of eligible patients participating. One promising solution is greater implementation of home-based CR. Both home and center-based CR programs have equal benefits on cardiovascular risk factors and quality of life. However, similar efficacy does not necessarily translate into similar effectiveness. If patients are more likely to participate in home- vs. center-based therapy, then greater participation could lead to greater clinical effectiveness. We are therefore conducting a quasi-experimental, controlled trial at two VA medical centers to determine the comparative effectiveness of referral to home- vs. center-based CR in patients with CHD. Aim 1: Determine whether automatic referral to home- vs. center-based CR increases patient participation in CR after hospitalization for myocardial infarction or coronary revascularization. Aim 2: Among patients who choose to participate in CR, compare the effectiveness of home- vs. center-based CR on six-minute walk distance, quality of life, and healthcare expenditures. Aim 3: Determine whether the effects of home vs. center-based CR differ by age, gender, race, ethnicity, employment, socioeconomic status, social support, comorbid conditions, or patient preference. Results from this study will (a) help policy makers determine the effect of covering home CR on healthcare expenditures in patients with CHD; (b) help providers understand the potential benefits and harms of home- vs. center-based CR; and (c) help patients answer questions like, "Given my personal circumstances and preferences, which of these options will improve the outcomes most important to me".

Conditions

Cardiac Rehabilitation

Keywords

cardiovascular disease; cardiac rehabilitation; secondary prevention; comparative effectiveness; 6 minute walk test

Outcome Measures

Primary Outcomes (1)

• Participation in Cardiac Rehabilitation

  Number of eligible patients who participated in at least one cardiac rehabilitation exercise session.

  12 Months

Other Outcomes (2)

• Change in Distance Completed on 6-minute Walk Test

  3 months

• Change in Distance Completed on 6-minute Walk Test

  6 months

Study Arms (2)

Home-based

EXPERIMENTAL

Referral to a home-based cardiac rehabilitation program (intervention).

Behavioral: Referral to center-based cardiac rehab

Center-based

ACTIVE COMPARATOR

Referral to a center-based cardiac rehabilitation program (standard of care).

Behavioral: Referral to home-based cardiac rehab

Interventions

Referral to home-based cardiac rehab BEHAVIORAL

Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes.

Center-based

Referral to center-based cardiac rehab BEHAVIORAL

Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting.

Home-based

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post MI, CABG, or PCI Able to speak, read and write in english

You may not qualify if:

• Class IV CHF Unstable Angina Complex Ventricular Arrythmias EF \<35% without AICD AICD candidate Resting SBP \>200mmHG Resting DBP\>110mmHG Cognitive Impairment by MoCA Score \<26 Life expectancy \<1 year

Sponsors & Collaborators

• University of California, San Francisco: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94116, United States

Location

Related Publications (1)

• Schopfer DW, Whooley MA, Allsup K, Pabst M, Shen H, Tarasovsky G, Duvernoy CS, Forman DE. Effects of Home-Based Cardiac Rehabilitation on Time to Enrollment and Functional Status in Patients With Ischemic Heart Disease. J Am Heart Assoc. 2020 Oct 20;9(19):e016456. doi: 10.1161/JAHA.120.016456. Epub 2020 Sep 21.

  PMID: 32954885 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Limitations and Caveats

CR referral process differed across sites: 90% of eligible patients were referred at the San Francisco (home-based CR) site, whereas 56% of eligible patients were referred at the Ann Arbor and Pittsburgh (center-based CR) sites.

Results Point of Contact

• Title: Dr. Mary Whooley
• Organization: San Francisco VA Healthcare System

mary.whooley@va.gov

415-221-4810

Study Officials

• Mary Whooley, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 7, 2014
• Study Start: July 15, 2015
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: April 1, 2019
• Results First Posted: April 1, 2019

Record last verified: 2019-01

Locations

US (1)