An interventional study of Cardiac Rehabilitation in Myocardial Ischemia, Acute Coronary Syndrome and Heart Disease, sponsored by University Health Network, Toronto. Completed at 5 sites in Canada. Open to female participants. Per ClinicalTrials.gov, last updated 2015-11-30.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Health services research
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.
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Exclusion Criteria:
The 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.
Behavioral: Cardiac Rehabilitation
The 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.
Behavioral: Cardiac Rehabilitation
In 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.
Behavioral: Cardiac Rehabilitation
comparison of multiple cardiac rehabilitation program models
CR Program Adherence
Time frame: 6 months
Exercise Capacity
Exercise capacity as measured by VO2peak on a graded stress test.
Time frame: 6 months
Exercise
Mean daily steps as measured by a pedometer over 7 days
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
Smoking
Current smoking status
Time frame: 6 months
| Milestone | Women-Only Cardiac Rehabilitation | Co-ed Cardiac Rehabilitation | Home-Based Cardiac Rehabilitation |
|---|---|---|---|
| Started | 55 | 59 | 55 |
| Completed | 35 | 40 | 24 |
| Not completed | 20 | 19 | 31 |
| Withdrew: Did not receive allocated intervention | 12 | 6 | 25 |
| Withdrew: Did not attend cr | 8 | 13 | 6 |
| percentage of sessions attended | Women-Only Cardiac Rehabilitation | Co-ed Cardiac Rehabilitation | Home-Based Cardiac Rehabilitation |
|---|---|---|---|
| CR Program Adherence | 54.40 ± 34.72 | 51.33 ± 35.7 | 58.12 ± 35.39 |
Exercise capacity as measured by VO2peak on a graded stress test.
| mL/(kg·min) | Women-Only Cardiac Rehabilitation | Co-ed Cardiac Rehabilitation | Home-Based Cardiac Rehabilitation |
|---|---|---|---|
| Exercise Capacity | 21.6071 ± 7.18327 | 20.8450 ± 6.51039 | 21.0734 ± 8.99184 |
Mean daily steps as measured by a pedometer over 7 days
| Daily steps | Women-Only Cardiac Rehabilitation | Co-ed Cardiac Rehabilitation | Home-Based Cardiac Rehabilitation |
|---|---|---|---|
| Exercise | 5296.9660 ± 2803.16268 | 6129.7143 ± 3107.17927 | 6694.3308 ± 4463.47290 |
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.
| Scores on a scale | Women-Only Cardiac Rehabilitation | Co-ed Cardiac Rehabilitation | Home-Based Cardiac Rehabilitation |
|---|---|---|---|
| Self-reported Exercise | 31.3243 ± 23.46517 | 31.4 ± 21.7922 | 29.5645 ± 14.29612 |
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.
| Scores on a scale | Women-Only Cardiac Rehabilitation | Co-ed Cardiac Rehabilitation | Home-Based Cardiac Rehabilitation |
|---|---|---|---|
| Diet | 202.2019 ± 24.34676 | 202.3477 ± 27.54240 | 213.9834 ± 32.89330 |
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.
| Scores on a scale | Women-Only Cardiac Rehabilitation | Co-ed Cardiac Rehabilitation | Home-Based Cardiac Rehabilitation |
|---|---|---|---|
| Medication Adherence | 3.6842 ± 0.57447 | 3.5238 ± 0.80359 | 3.5833 ± 0.76997 |
Current smoking status
| Participants | Women-Only Cardiac Rehabilitation | Co-ed Cardiac Rehabilitation | Home-Based Cardiac Rehabilitation |
|---|---|---|---|
| Smoking | 1 | 3 | 3 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Women-Only Cardiac Rehabilitation | — | 0/55 (0%) | 0/55 (0%) |
| Co-ed Cardiac Rehabilitation | — | 0/59 (0%) | 0/59 (0%) |
| Home-Based Cardiac Rehabilitation | — | 0/55 (0%) | 0/55 (0%) |
| Age, Continuous(years) | Women-Only Cardiac Rehabilitation | Co-ed Cardiac Rehabilitation | Home-Based Cardiac Rehabilitation | Total |
|---|---|---|---|---|
| Mean | 66.22 ± 10.21 | 61.56 ± 9.73 | 63.13 ± 10.94 | 63.64 ± 10.42 |
| Sex/Gender, Customized(participants) | Women-Only Cardiac Rehabilitation | Co-ed Cardiac Rehabilitation | Home-Based Cardiac Rehabilitation | Total |
|---|---|---|---|---|
| Females | 55 | 59 | 55 | 169 |
| Race/Ethnicity, Customized(participants) | Women-Only Cardiac Rehabilitation | Co-ed Cardiac Rehabilitation | Home-Based Cardiac Rehabilitation | Total |
|---|---|---|---|---|
| White | 26 | 32 | 32 | 90 |
| Other | 29 | 27 | 23 | 79 |
| Region of Enrollment(participants) | Women-Only Cardiac Rehabilitation | Co-ed Cardiac Rehabilitation | Home-Based Cardiac Rehabilitation | Total |
|---|---|---|---|---|
| Canada | 55 | 59 | 55 | 169 |
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University Health Network, Toronto