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| Name | Class |
|---|---|
| Heart and Stroke Foundation of Ontario | OTHER |
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A randomized control trial (RCT) is planned to evaluate a web-based intervention (CardioFit) against usual care in increasing physical activity levels in patients with Coronary Artery Disease (CAD). We hypothesize that compared to usual care, participants in CardioFit will; a) have increased physical activity levels, b) will have a higher health-related quality of life at measurement dates and, c) will have greater improvements in psychosocial predictors.
Most existing cardiac rehabilitation programs have little ability to expand participation using traditional delivery models that emphasize supervised, facility-based programs. Futhermore, facility based programs to promote physical activity behavior in patients with coronary artery disease (CAD) are limited in their impact because most patients are unwilling to travel more than 30-40 minutes to participate in a program. CardioFit is an off-site, 26 week web-based physical activity coaching service for people with heart disease. Within the CardioFit program, patients will be assigned to an on-line "coach" and receive customized exercise programs based on their medical history, personal goals and preferences. A randomized control trial (RCT) is planned to evaluate the effectiveness of the web-based intervention at increasing physical activity levels against usual care in patients with CAD.
This study is in the third phase of a three-phase research program to examine interventions to promote physical activity for the secondary prevention of Cardiovascular disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardio fit | Experimental |
| |
| Usual Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioFit | Behavioral | CardioFit is a 26-week tailored web-based physical activity coaching service for individuals with Coronary Artery Disease (CAD). It has been designed to help patients develop personalized exercise programs based on their medical history, personal goals and preferences. Access to Cardio-fit is through a secured website. The cardio-fit website contains physical activity advice and heart health educational information. Each patient is assigned an on-line coach, whose role is to assist in creating safe an effective physical activity program, and to answer any questions that patients may have throughout the program. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity: Measured at Baseline (Day of Hospital Discharge), 6 Months and 12 Months Via Pedometer | Baseline, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate or Vigorous Physical Activity | baseline to 12 months | |
| Heart Disease Health-related Quality of Life | Measured at 6months and 12months via MacNew instrument. Each subscale ranges from 1-7 (1 = worse quality of life, 7 = better quality of life), and is reported independently from each of the other subscales. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Reid, PhD | University of Ottawa Heart Institute, Prevention and Rehabilitation Centre | Principal Investigator |
| Andrew Pipe, C.M, MD | University of Ottawa Heart Institute, Prevention and Rehabilitation Centre | Study Chair |
| Louise Morrin, MBA, B.Sc. | University of Ottawa Heart Institute, Prevention and Rehabilitation Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada | ||
| Unversity of Ottawa Heart Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21903744 | Derived | Reid RD, Morrin LI, Beaton LJ, Papadakis S, Kocourek J, McDonnell L, Slovinec D'Angelo ME, Tulloch H, Suskin N, Unsworth K, Blanchard C, Pipe AL. Randomized trial of an internet-based computer-tailored expert system for physical activity in patients with heart disease. Eur J Prev Cardiol. 2012 Dec;19(6):1357-64. doi: 10.1177/1741826711422988. Epub 2011 Sep 8. | |
| 21450579 |
| Label | URL |
|---|---|
| University of Ottawa Heart Institute website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardio Fit | Participants were provided a tailored physical activity plan generated by the CardioFit system, and instructions on how to access the CardioFit website. |
| FG001 | Usual Care | Participants received activity guidance from their attending cardiologist and an education booklet. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cardio Fit | Participants were provided a tailored physical activity plan generated by the CardioFit system, and instructions on how to access the CardioFit website. |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physical Activity: Measured at Baseline (Day of Hospital Discharge), 6 Months and 12 Months Via Pedometer | Posted | Mean | Standard Deviation | Number of Steps per day over 7 days | Baseline, 6 and 12 months |
|
Baseline to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cardio Fit | Participants were provided a tailored physical activity plan generated by the CardioFit system, and instructions on how to access the CardioFit website. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for chest pain | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Reid | University of Ottawa Heart Institute | 6136967000 | EQuirouette@ottawaheart.ca |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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The Research Assistants conducting the follow-up assessments were blinded to the participant's treatment allocation.
|
| 6 months and 12 months |
| Ottawa |
| Ontario |
| K1Y 4W7 |
| Canada |
| Reid RD, Morrin LI, Higginson LA, Wielgosz A, Blanchard C, Beaton LJ, Nelson C, McDonnell L, Oldridge N, Wells GA, Pipe AL. Motivational counselling for physical activity in patients with coronary artery disease not participating in cardiac rehabilitation. Eur J Prev Cardiol. 2012 Apr;19(2):161-6. doi: 10.1177/1741826711400519. Epub 2011 Feb 21. |
Participants received activity guidance from their attending cardiologist and an education booklet.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Formal Education | Mean | Standard Deviation | Years of Formal Education |
|
| Current smokers | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Diabetic | Count of Participants | Participants |
|
| Acute Myocardial Infarction this admission | Count of Participants | Participants |
|
| Percutaneous Coronary Intervention this admission | Count of Participants | Participants |
|
| Experiencing first cardiac event | Count of Participants | Participants |
|
| Previous Acute Myocardial Infarction | Count of Participants | Participants |
|
| Previous Percutaneous Intervention | Count of Participants | Participants |
|
| Previous Coronary Artery Bypass Grafting | Count of Participants | Participants |
|
| Pre-hospital physical activity level | Mean | Standard Deviation | Metabolic Equivalent of Tasks (METs) |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Moderate or Vigorous Physical Activity | Posted | Mean | Standard Deviation | Minutes per week | baseline to 12 months |
|
|
|
| Secondary | Heart Disease Health-related Quality of Life | Measured at 6months and 12months via MacNew instrument. Each subscale ranges from 1-7 (1 = worse quality of life, 7 = better quality of life), and is reported independently from each of the other subscales. | Posted | Mean | Standard Deviation | Scores on a scale | 6 months and 12 months |
|
|
|
| 0 |
| 115 |
| 4 |
| 115 |
| 0 |
| 115 |
| EG001 | Usual Care | Participants received activity guidance from their attending cardiologist and an education booklet. | 2 | 108 | 7 | 108 | 0 | 108 |
| Coronary Artery Bypass Grafting | Cardiac disorders | Systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Emotional subscale - 6 months |
|
| Emotional subscale - 12 months |
|
| Social subscale - 6 months |
|
| Social subscale - 12 months |
|
| Physical subscale - 6 months |
|
| Physical subscale - 12 months |
|