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Myocardial IschemiaCR4HERNCT01019135

Cardiac Rehabilitation for Heart Event Recovery (HER)

A study testing Cardiac Rehabilitation in people with Myocardial Ischemia and Acute Coronary Syndrome, run by University Health Network, Toronto at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Any age, women only
What is being tested?
Cardiac Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
169 participants
Where
5 sitesCanada
Study dates
Nov 2009to Mar 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Hamilton Health Sciences Centre

    Hamilton, Ontario, L8N3Z5

  • Mount Sinai

    Toronto, Ontario, M3K 1G5

  • Toronto Rehabilitation Institute

    Toronto, Ontario, M4G1R7

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N3M5

  • University Health Network

    Toronto, Ontario, M5G2C4

Other trials in Canada

About this study

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])

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

Read the 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.

Being tested
Cardiac Rehabilitation
Keywords
Women, Cardiac Care Facilities, Patient satisfaction, Patient participation, Patient compliance, Randomized Control Trial, Coronary artery bypass, Angioplasty, transluminal, percutaneous coronary
Medical subject headings
Myocardial Ischemia, Acute Coronary Syndrome, Heart Diseases, Coronary Artery Disease, Patient Satisfaction, Patient Participation, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac RehabilitationBehavioural

    comparison of multiple cardiac rehabilitation program models

Study groups in NCT01019135
Study groupRoleWhat they receive
Women-Only Cardiac RehabilitationActive comparatorThe women-only CR programs include on-site group exercise training sessions 1-2 days/week. Participants are encouraged to walk at home on alternate days of the week. Education sessions are also given in a group format, wherein participants engage in on-site female-only group exercise sessions, as well as female-only group education sessions.
Receives: Behavioral: Cardiac Rehabilitation
Co-ed Cardiac RehabilitationActive comparatorThe traditional hospital-based co-ed CR programs include on-site group exercise training sessions 1-2 days/week. Participants are encouraged to walk at home on alternate days of the week. Education sessions are also given in a group format.
Receives: Behavioral: Cardiac Rehabilitation
Home-Based Cardiac RehabilitationActive comparatorIn the monitored home-based programs, patients attend an intake appointment where an exercise test is performed as the basis for exercise prescription. Patients are given written guidelines for aerobic conditioning based on their treadmill test. Patients are cautioned about symptoms, and taught how to check their heart rate during walking sessions. Patients are provided with reading materials regarding CVD, risk factors and lifestyle modification. These are discussed with an allied health professional from the home-based CR program by telephone during weekly scheduled telephone calls.
Receives: Behavioral: Cardiac Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CR Program Adherence

    Measured: 6 months

Secondary outcomes (6)

  1. Exercise Capacity

    Exercise capacity as measured by VO2peak on a graded stress test.

    Measured: 6 months

  2. Exercise

    Mean daily steps as measured by a pedometer over 7 days

    Measured: 6 months

  3. Self-reported Exercise

    The Godin Leisure-time Exercise Questionnaire will be administered in the pre and post-test surveys. It is a brief and reliable instrument to assess usual leisure-time physical activity behaviour during a one-week period. For the first question, weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Part two of the questionnaire calculates the frequency of weekly leisure-time activities pursued. Total weekly leisure activity is calculated by summing the products of the separate components. Scores begin at zero, with higher scores indicating greater physical activity. For example, scores equal to or greater than 20 are indicative of someone who is "active". There is no max score.

    Measured: 6 months

  4. Diet

    The Diet Habit Survey was used to assess diet. It is an inexpensive, reliable, and valid instrument for rapid assessment of eating habits and diet composition. Its 9 questions are related to the consumption of cholesterol, saturated fat, complex carbohydrate (including fiber), and salt.

    Greater scores indicate better diets, both for the total score and for each area. The total score indicates the level of fat in the diet (with scores equal to or greater than 236 corresponding to a low-fat diet 20% or less). Scores can begin at 56 and have no upper range.

    Measured: 6 months

  5. Medication Adherence

    The 4-item Morisky Medication Adherence Scale was used, which is scored as yes = 0, no = 1, such that a higher score indicates higher medication adherence. Scores range from 0 to 4, with patients scoring 2 or above considered adherent.

    Measured: 6 months

  6. Smoking

    Current smoking status

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01019135
Sponsor's protocol ID
Cardiac Rehab for Women
Acronym
CR4HER
Status last verified
Oct 2015
First submitted
20 Nov 2009
Last updated
30 Nov 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 26682921

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac Rehabilitation in people with Myocardial Ischemia and Acute Coronary Syndrome, run by University Health Network, Toronto at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CR Program Adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01019135, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2015.

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