Cardiac Rehabilitation for Heart Event Recovery (HER) (CR4HER)

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Sherry Grace, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01019135
First received: November 20, 2009
Last updated: March 9, 2014
Last verified: March 2014

November 20, 2009
March 9, 2014
November 2009
March 2014   (final data collection date for primary outcome measure)
CR program adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
CR program adherence [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01019135 on ClinicalTrials.gov Archive Site
  • exercise capacity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • exercise, diet, smoking behaviour, and medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • psychosocial and other factors affecting women's CR adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • exercise capacity [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • exercise, diet, smoking behaviour, and medication adherence [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • psychosocial and other factors affecting women's CR adherence [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cardiac Rehabilitation for Heart Event Recovery (HER)
A Randomized Controlled Trial of Women's Adherence to Women-only, Home-based and Traditional Cardiac Rehabilitation (Cardiac Rehabilitation for Her Heart Event Recovery [CR4HER])

The purpose of this study is to compare women's cardiac rehabilitation program adherence across three program models.

Heart disease is the leading cause of morbidity and mortality for women in Canada. Cardiac rehabilitation (CR) is an outpatient secondary prevention program composed of structured exercise and comprehensive education and counseling. CR participation results in lower morbidity and mortality, among other benefits. Unfortunately, women are significantly less likely to adhere to these programs than men. While the traditional model of CR care is a hospital-based mixed-sex program, women are the minority in such programs, and state that these programs do not meet their care preferences. Two other models of CR care have been developed: hospital-based women-only (sex-specific) and monitored home-based programs. Other than through our controlled pilot testing of 36 patients, women's adherence to these program models is not well known.

CR4HER is a 3 parallel arm pragmatic RCT designed to compare program adherence to traditional hospital-based CR with males and females, home-based CR, and women-only hospital-based CR. Power calculations based on our pilot study suggest a sample size of 261 patients is needed to detect a difference in adherence by program model using ANCOVA. Participants are female CAD, acute coronary syndrome, percutaneous coronary intervention, bypass surgery, or valve surgery inpatients recruited from 5 hospitals. Also, female patients referred to participating cardiac rehabilitation (3) centres with one of the aforementioned diagnosis will be approached to participate. The primary outcome variable is program adherence operationalized as CR site-reported percentage of prescribed sessions completed by phone or on-site, as reported by a staff member who is blind to study objectives. Secondary outcomes are exercise capacity operationalized as VO2peak on a graded stress test, and exercise, dietary, smoking and medication adherence behaviours measured in hospital and 1 week post-CR. By identifying the CR program model which results in the greatest adherence for women, we can optimize their participation and potentially their cardiac outcomes.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
  • Myocardial Ischemia
  • Acute Coronary Syndrome
  • Heart Disease
  • Coronary Artery Disease
Behavioral: Cardiac Rehabilitation
comparison of multiple cardiac rehabilitation program models
  • Active Comparator: Women-Only Cardiac Rehabilitation
    Intervention: Behavioral: Cardiac Rehabilitation
  • Active Comparator: Co-ed Cardiac Rehabilitation
    Intervention: Behavioral: Cardiac Rehabilitation
  • Active Comparator: Home-Based Cardiac Rehabilitation
    Intervention: Behavioral: Cardiac Rehabilitation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
326
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented coronary artery disease and/or acute coronary syndrome diagnosis and/or revascularization (coronary bypass graft or angioplasty) and/or valve surgery
  • Work or reside in Greater Toronto Area
  • Proficiency in English language
  • Written approval to participate in CR by the patient's cardiac specialist or general practitioner
  • Eligible for home-based CR

Exclusion Criteria:

  • musculoskeletal, neuromuscular, visual, cognitive or non-dysphoric psychiatric condition, or any serious or terminal illness not otherwise specified which would preclude CR eligibility based on CR guidelines
  • physician deems patient not suitable for CR at time of intake exercise stress test
  • planning to leave the area prior to the anticipated end of participation
  • being discharged to a long-term care facility
  • participation in another clinical trial with behavioral interventions
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01019135
Cardiac Rehab for Women
No
Sherry Grace, University Health Network, Toronto
University Health Network, Toronto
Heart and Stroke Foundation of Ontario
Principal Investigator: Sherry L Grace, PhD University Health Network & York University
Study Chair: Heather M Arthur, PhD McMaster University
Study Chair: Paul Oh, MD Toronto Rehabilitation Institute
Study Chair: Caroline Chessex, MD University Health Network, Toronto
Study Chair: Stephanie Brister, MD University Health Network, Toronto
University Health Network, Toronto
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP