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| Name | Class |
|---|---|
| Heart and Stroke Foundation of Canada | OTHER |
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Background: Family members (spouses, siblings, offspring) of patients with coronary heart disease (CHD) may themselves be at increased risk for developing CHD for genetic, biochemical and/or behavioural reasons. Targeted approaches aimed at family members of those with established CHD may be a cost-effective way to identify high-risk persons and link them to effective risk factor modification. During pilot testing we found 29% of family members of patients recently hospitalized at our institution had ≥ 3 CHD risk factors. Encouragingly, they indicated high levels of "readiness" to change underlying risk behaviours such as cigarette smoking and physical inactivity. We have developed a 12-week family heart health program featuring a personal plan for achieving risk factor goals and weekly contact with a heart health educator. This intervention needs to be fully tested.
Research Aims:
In this study, we will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Family Heart Health Program |
|
| 2 | No Intervention | Usual Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12-week risk reduction program, managed by a Heart Health Educator | Behavioral | The educator and participant will negotiate a personal plan for achieving the goals through lifestyle change (i.e. smoking cessation, increased exercise, improved nutrition) and, if necessary, pharmacotherapy coordinated by the participant's personal physician. Educational modules have been developed to address specific lifestyle issues including smoking cessation, healthy eating, exercise, and weight management, and will be provided to participants as required. A summary of the risk factor profile and personal plan will be incorporated into a report for the participant's personal physician as well. Participants will also receive telephone-based motivational counseling sessions for 12 weeks to address specific lifestyle issues. |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Total Cholesterol to HDL Cholesterol TC/HDL | Baseline to one year | |
| Physical Activity | Baseline to 1 year | |
| Servings of Fruits and Vegetables | Baseline to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cholesterol Levels | Baseline to 1 year | |
| Glucose Levels | Baseline to 1 year | |
| Blood Pressure |
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Inclusion Criteria:
Spouse, offspring or sibling of patient hospitalized at UOHI within the past 5 years for:
Willing to provide informed consent;
At least one of the following modifiable risk factors:
Geographically available for assessment, intervention and follow-up.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert D Reid, MBA, PhD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Andrew L Pipe, MD | Ottawa Heart Institute Research Corporation | Study Chair |
| Lori J Mosca, MD, PhD | New York Presbyterian Hospital | Study Chair |
| Heidi Mochari, MPH, RD | New York Presbyterian Hospital | Study Chair |
| George Wells, PhD | Ottawa Heart Institute Research Corporation | Study Chair |
| Louise J Beaton, MSc | Ottawa Heart Institute Research Corporation | Study Chair |
| Pat O'Farrell, RN | Ottawa Heart Institute Research Corporation | Study Chair |
| Chris M Blanchard, PhD | Dalhousie University | Study Chair |
| Sophia Papadakis, MHA | Ottawa Heart Institute Research Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24246588 | Derived | Reid RD, McDonnell LA, Riley DL, Mark AE, Mosca L, Beaton L, Papadakis S, Blanchard CM, Mochari-Greenberger H, O'Farrell P, Wells GA, Slovinec D'Angelo ME, Pipe AL. Effect of an intervention to improve the cardiovascular health of family members of patients with coronary artery disease: a randomized trial. CMAJ. 2014 Jan 7;186(1):23-30. doi: 10.1503/cmaj.130550. Epub 2013 Nov 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Family Heart-Health Intervention | Assessment of family members of patients with CAD. Provides feedback about risk factors, assistance with goal setting and counselling from health educators. Reports were provided to primary care providers if they exceeded normal ranges. Participants also received printed materials about smoking cessation, healthy eating, weight management, and physical activity. |
| FG001 | Control Group | Participants received printed materials about smoking cessation, healthy eating, weight management, and physical activity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Family Heart-Health Intervention | Assessment of family members of patients with CAD. Provides feedback about risk factors, assistance with goal setting and counselling from health educators. Reports were provided to primary care providers if they exceeded normal ranges. Participants also received printed materials about smoking cessation, healthy eating, weight management, and physical activity. |
| 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 | Ratio of Total Cholesterol to HDL Cholesterol TC/HDL | Posted | Mean | Standard Deviation | Ratio | Baseline to one year |
|
Baseline to 1 year
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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 | Family Heart-Health Intervention | Assessment of family members of patients with CAD. Provides feedback about risk factors, assistance with goal setting and counselling from health educators. Reports were provided to primary care providers if they exceeded normal ranges. Participants also received printed materials about smoking cessation, healthy eating, weight management, and physical activity. |
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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 |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| Baseline to 1 year |
| Body Mass Index | Baseline to 1 year |
| Waist Circumference | Baseline to 1 year |
| Monika Slovinec D'Angelo, PhD |
| Ottawa Heart Institute Research Corporation |
| Study Chair |
| BG001 | Control Group | Participants received printed materials about smoking cessation, healthy eating, weight management, and physical activity. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Married or living with partner | Count of Participants | Participants |
|
| Education | Number of years in formal education | Mean | Standard Deviation | years |
|
| Family history of premature CAD | Count of Participants | Participants |
|
| Current daily smoker | Count of Participants | Participants |
|
| No family doctor | Count of Participants | Participants |
|
| Body Mass Index >/= 30 | Count of Participants | Participants |
|
| Waist circumference >94cm (men) or >80cm (women) | Count of Participants | Participants |
|
| Lipid lowering therapy | Count of Participants | Participants |
|
| Antihypertensive therapy | Count of Participants | Participants |
|
| Smoking cessation pharmacotherapy | Count of Participants | Participants |
|
| Relation to index patient | Count of Participants | Participants |
|
| Percent risk of CAD event over next 10year | Mean | Standard Deviation | Percent |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Physical Activity | Posted | Mean | Standard Deviation | minutes/week | Baseline to 1 year |
|
|
|
| Primary | Servings of Fruits and Vegetables | Posted | Mean | Standard Deviation | Servings per day | Baseline to 1 year |
|
|
|
| Secondary | Cholesterol Levels | Posted | Mean | Standard Deviation | mmol/L | Baseline to 1 year |
|
|
|
| Secondary | Glucose Levels | Posted | Mean | Standard Deviation | mmol/L | Baseline to 1 year |
|
|
|
| Secondary | Blood Pressure | Posted | Mean | Standard Deviation | mmHg | Baseline to 1 year |
|
|
|
| Secondary | Body Mass Index | Posted | Mean | Standard Deviation | kg/m2 | Baseline to 1 year |
|
|
|
| Secondary | Waist Circumference | Posted | Mean | Standard Deviation | centimeters | Baseline to 1 year |
|
|
|
| 0 |
| 211 |
| 0 |
| 211 |
| 0 |
| 211 |
| EG001 | Control Group | Participants received printed materials about smoking cessation, healthy eating, weight management, and physical activity. | 0 | 215 | 0 | 215 | 0 | 215 |
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| at 12months |
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| at 12 months |
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| 12month - Total Cholesterol |
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| Baseline - HDL Cholesterol |
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| 3month - HDL cholesterol |
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| 12month - HDL cholesterol |
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| Baseline - LDL cholesterol |
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| 3months - LDL cholesterol |
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| 12months - LDL cholesterol |
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| Baseline - Triglycerides |
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| 3months - Triglycerides |
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| 12month - Triglycerides |
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| at 12 months |
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| 3 months - Systolic |
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| 3 months - Diastolic |
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| 12 months - Systolic |
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| 12 months - Diastolic |
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| 12 months |
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| at 12 months |
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