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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00552591 |
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Date of registration:
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01/11/2007 |
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Primary sponsor: |
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Public title:
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Family Heart Health Program: Randomized, Controlled Trial
FHHP-RCT |
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Scientific title:
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Family Heart Health Program: Randomized, Controlled Trial |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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426 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00552591 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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Canada
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Contacts
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Name:
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Chris M Blanchard, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dalhousie University |
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Name:
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Heidi Mochari, MPH, RD |
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Address:
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Email:
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Affiliation:
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New York Presbyterian Hospital |
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Name:
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Lori J Mosca, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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New York Presbyterian Hospital |
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Name:
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Andrew L Pipe, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Ottawa Heart Institute |
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Name:
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George Wells, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Ottawa Heart Institute |
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Name:
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Louise J Beaton, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Ottawa Heart Institute |
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Name:
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Monika Slovinec D'Angelo, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Ottawa Heart Institute |
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Name:
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Pat O'Farrell, RN |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Ottawa Heart Institute |
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Name:
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Robert D Reid, MBA, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Ottawa Heart Institute |
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Name:
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Sophia Papadakis, MHA |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Ottawa Heart Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Spouse, offspring or sibling of patient hospitalized at UOHI within the past 5 years
for:
1. Acute coronary syndrome (ACS);
2. Elective percutaneous coronary intervention (PCI); or
3. Bypass surgery (CABG);
- Willing to provide informed consent;
- At least one of the following modifiable risk factors:
1. Current smoker;
2. Systolic blood pressure = 140 and or Diastolic BP = 90 and/or currently on
medication to treat high blood pressure;
3. Total cholesterol/HDL-cholesterol ratio = 5.0 and/or on antilipemic medication;
4. Abdominal obesity (for men, waist circumference > 102 cm; for women, waist
circumference > 88cm);
5. Physical Inactivity [<150 min mod, 5-7 d/week or <100 min vig, 4-7 d/week]
- Geographically available for assessment, intervention and follow-up.
Exclusion Criteria:
1. Unable to understand English or French;
2. History of diabetes mellitus or any atherosclerotic disease;
3. Fasting glucose = 7.0 mmol/L at screening;
4. Presence of life threatening illness (e.g., known or suspected cancer or other
disease with a life expectancy of less than five years);
5. Chronic kidney disease and/or undergoing dialysis;
6. Active liver disease;
7. Pregnant or planning to become pregnant within the next year;
8. Cognitive impairment;
9. Other family member already participating in study.
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Heart Disease
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Intervention(s)
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Behavioral: 12-week risk reduction program, managed by a Heart Health Educator
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Primary Outcome(s)
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TC/HDL ratio
[Time Frame: one year]
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Secondary Outcome(s)
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Secondary outcomes of interest will include the modifiable components comprising the Framingham score (smoking status, systolic BP, total cholesterol, HDL- and LDL-cholesterol)
[Time Frame: 12 weeks and one year]
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Use of risk reducing medications, use of health care resources, smoking status, leisure time exercise, dietary patterns, and body composition
[Time Frame: 12 weeks and one year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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