Clinical trial NCT01019135: Cardiac Rehabilitation for Heart Event Recovery (HER)
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])
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemia
Acute Coronary Syndrome
Heart Disease
Coronary Artery Disease
Keywords: Women
Cardiac Care Facilities
Patient satisfaction
Patient participation
Patient compliance
Randomized Control Trial
Coronary artery bypass
Angioplasty, transluminal, percutaneous coronary
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2009-11-25
Enrollment: 169
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare women's cardiac rehabilitation program adherence across three 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 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

Primary outcomes:
measure: CR Program Adherence
timeFrame: 6 months
Secondary outcomes:
measure: Exercise Capacity
timeFrame: 6 months
measure: Exercise
timeFrame: 6 months
measure: Self-reported Exercise
timeFrame: 6 months
measure: Diet
timeFrame: 6 months
measure: Medication Adherence
timeFrame: 6 months
measure: Smoking
timeFrame: 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai
state: Ontario
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network & York University
name: Sherry L Grace, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Heather M Arthur, PhD
role: STUDY_CHAIR
affiliation: Toronto Rehabilitation Institute
name: Paul Oh, MD
role: STUDY_CHAIR
affiliation: University Health Network, Toronto
name: Caroline Chessex, MD
role: STUDY_CHAIR
affiliation: University Health Network, Toronto
name: Stephanie Brister, MD
role: STUDY_CHAIR
References:
citation: Grace SL, Midence L, Oh P, Brister S, Chessex C, Stewart DE, Arthur HM. Cardiac Rehabilitation Program Adherence and Functional Capacity Among Women: A Randomized Controlled Trial. Mayo Clin Proc. 2016 Feb;91(2):140-8. doi: 10.1016/j.mayocp.2015.10.021. Epub 2015 Dec 10.