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

This study is currently recruiting participants.
Verified November 2009 by University Health Network, Toronto
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01019135
First received: November 20, 2009
Last updated: October 14, 2010
Last verified: November 2009
History of Changes
  Purpose

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


Condition Intervention
Myocardial Ischemia
Acute Coronary Syndrome
Heart Disease
Coronary Artery Disease
 Behavioral: Cardiac Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: 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])

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • CR program adherence [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 326
Study Start Date: November 2009
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Women-Only Cardiac Rehabilitation Behavioral: Cardiac Rehabilitation
comparison of multiple cardiac rehabilitation program models
Active Comparator: Co-ed Cardiac Rehabilitation Behavioral: Cardiac Rehabilitation
comparison of multiple cardiac rehabilitation program models
Active Comparator: Home-Based Cardiac Rehabilitation Behavioral: Cardiac Rehabilitation
comparison of multiple cardiac rehabilitation program models

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019135

Contacts
Contact: Lori Van Langen, MSc. 416-340-4800 ext 6593 lvanlang@uhnresearch.ca
Contact: Kelly Russell, MSc. 416-340-4800 ext 6593 kelly.russell@uhn.on.ca

Locations
Canada, Ontario
Hamilton Health Sciences Centre Not yet recruiting
Hamilton, Ontario, Canada, L8N3Z5
Principal Investigator: Heather Arthur, PhD            
University Health Network Recruiting
Toronto, Ontario, Canada, M5G2C4
Principal Investigator: Sherry Grace, PhD            
Sub-Investigator: Caroline Chessex, MD            
Sub-Investigator: Stephanie Brister, MD            
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Principal Investigator: Paul Oh, MD            
Mount Sinai Recruiting
Toronto, Ontario, Canada, M3K 1G5
Principal Investigator: Donna Stewart, MD            
Toronto Rehabilitation Institute Recruiting
Toronto, Ontario, Canada, M4G1R7
Principal Investigator: Paul Oh, MD            
Sponsors and Collaborators
University Health Network, Toronto
Heart and Stroke Foundation of Ontario
Investigators
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
  More Information

No publications provided

Responsible Party: Sherry L. Grace, University Health Network & York University
ClinicalTrials.gov Identifier: NCT01019135     History of Changes
Other Study ID Numbers: Cardiac Rehab for Women
Study First Received: November 20, 2009
Last Updated: October 14, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Women
Cardiac Care Facilities
Patient satisfaction
Patient participation
 Patient compliance
Randomized Control Trial
Coronary artery bypass
Angioplasty, transluminal, percutaneous coronary

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Acute Coronary Syndrome
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013