Acute Coronary Syndrome, Coronary Artery Disease, Heart Disease, Myocardial Ischemia
Conditions
Keywords
Women, Cardiac Care Facilities, Patient satisfaction, Patient participation, Patient compliance, Randomized Control Trial, Coronary artery bypass, Angioplasty, transluminal, percutaneous coronary
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.
Interventions
BEHAVIORALCardiac Rehabilitation
comparison of multiple cardiac rehabilitation program models
Sponsors
Heart and Stroke Foundation of Ontario
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR Program Adherence | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise | 6 months | Mean daily steps as measured by a pedometer over 7 days |
| Self-reported Exercise | 6 months | 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. |
| Exercise Capacity | 6 months | Exercise capacity as measured by VO2peak on a graded stress test. |
| Medication Adherence | 6 months | 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. |
| Smoking | 6 months | Current smoking status |
| Diet | 6 months | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Women-Only Cardiac Rehabilitation Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models | 55 |
| Co-ed Cardiac Rehabilitation Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models | 59 |
| Home-Based Cardiac Rehabilitation Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models | 55 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not attend CR | 8 | 13 | 6 |
| Overall Study | Did not receive allocated intervention | 12 | 6 | 25 |
Baseline characteristics
| Characteristic | Co-ed Cardiac Rehabilitation | Home-Based Cardiac Rehabilitation | Women-Only Cardiac Rehabilitation | Total |
|---|---|---|---|---|
| Age, Continuous | 61.56 years STANDARD_DEVIATION 9.73 | 63.13 years STANDARD_DEVIATION 10.94 | 66.22 years STANDARD_DEVIATION 10.21 | 63.64 years STANDARD_DEVIATION 10.42 |
| Race/Ethnicity, Customized Other | 27 participants | 23 participants | 29 participants | 79 participants |
| Race/Ethnicity, Customized White | 32 participants | 32 participants | 26 participants | 90 participants |
| Region of Enrollment Canada | 59 participants | 55 participants | 55 participants | 169 participants |
| Sex/Gender, Customized Females | 59 participants | 55 participants | 55 participants | 169 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 0 / 59 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 59 | 0 / 55 |
Outcome results
Primary
CR Program Adherence
Time frame: 6 months
Population: Participants with available data for adherence
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women-Only Cardiac Rehabilitation | CR Program Adherence | 54.40 percentage of sessions attended | Standard Deviation 34.72 |
| Co-ed Cardiac Rehabilitation | CR Program Adherence | 51.33 percentage of sessions attended | Standard Deviation 35.7 |
| Home-Based Cardiac Rehabilitation | CR Program Adherence | 58.12 percentage of sessions attended | Standard Deviation 35.39 |
Secondary
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
Population: Participants with available data for diet
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women-Only Cardiac Rehabilitation | Diet | 202.2019 Scores on a scale | Standard Deviation 24.34676 |
| Co-ed Cardiac Rehabilitation | Diet | 202.3477 Scores on a scale | Standard Deviation 27.5424 |
| Home-Based Cardiac Rehabilitation | Diet | 213.9834 Scores on a scale | Standard Deviation 32.8933 |
Secondary
Exercise
Mean daily steps as measured by a pedometer over 7 days
Time frame: 6 months
Population: Participants with available data for exercise
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women-Only Cardiac Rehabilitation | Exercise | 5296.9660 Daily steps | Standard Deviation 2803.16268 |
| Co-ed Cardiac Rehabilitation | Exercise | 6129.7143 Daily steps | Standard Deviation 3107.17927 |
| Home-Based Cardiac Rehabilitation | Exercise | 6694.3308 Daily steps | Standard Deviation 4463.4729 |
Secondary
Exercise Capacity
Exercise capacity as measured by VO2peak on a graded stress test.
Time frame: 6 months
Population: Participants with available data for exercise capacity
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women-Only Cardiac Rehabilitation | Exercise Capacity | 21.6071 mL/(kg·min) | Standard Deviation 7.18327 |
| Co-ed Cardiac Rehabilitation | Exercise Capacity | 20.8450 mL/(kg·min) | Standard Deviation 6.51039 |
| Home-Based Cardiac Rehabilitation | Exercise Capacity | 21.0734 mL/(kg·min) | Standard Deviation 8.99184 |
Secondary
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
Population: Participants with available data for medication adherence
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women-Only Cardiac Rehabilitation | Medication Adherence | 3.6842 Scores on a scale | Standard Deviation 0.57447 |
| Co-ed Cardiac Rehabilitation | Medication Adherence | 3.5238 Scores on a scale | Standard Deviation 0.80359 |
| Home-Based Cardiac Rehabilitation | Medication Adherence | 3.5833 Scores on a scale | Standard Deviation 0.76997 |
Secondary
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
Population: Participants with available data for self-reported exercise
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women-Only Cardiac Rehabilitation | Self-reported Exercise | 31.3243 Scores on a scale | Standard Deviation 23.46517 |
| Co-ed Cardiac Rehabilitation | Self-reported Exercise | 31.4 Scores on a scale | Standard Deviation 21.7922 |
| Home-Based Cardiac Rehabilitation | Self-reported Exercise | 29.5645 Scores on a scale | Standard Deviation 14.29612 |
Secondary
Smoking
Current smoking status
Time frame: 6 months
Population: Participants with available data for current smoking status. Reported values in the table represent number of participants who were current smokers.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Women-Only Cardiac Rehabilitation | Smoking | 1 Participants |
| Co-ed Cardiac Rehabilitation | Smoking | 3 Participants |
| Home-Based Cardiac Rehabilitation | Smoking | 3 Participants |