Family Heart Health Program: Randomized, Controlled Trial (FHHP-RCT)

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Dr Robert Reid, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT00552591
First received: November 1, 2007
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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:

  1. Compare the effects of a targeted family heart health (FHH) screening, counselling and follow-up program versus usual care (UC) for reducing participants total cholesterol/high density lipoprotein (TC/HDL) ratio 52 weeks after program entry, in family members of patients recently hospitalized with CHD;
  2. Compare the effects of the FHH program versus UC on modifiable components comprising the Framingham score, including: smoking status; systolic blood pressure; total cholesterol; and high density lipoprotein cholesterol;
  3. Compare the effects of the FHH program versus UC on: lifestyle-related factors (dietary patterns, leisure time exercise, body composition); medication use (anti-lipemic medications, anti-hypertensive medications, pharmacotherapies for smoking cessation); and use of healthcare resources (physician visits, hospitalization days, number of laboratory and diagnostic tests and procedures).

Condition Intervention
Coronary Heart Disease
Behavioral: 12-week risk reduction program, managed by a Heart Health Educator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Family Heart Health Program: Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • TC/HDL ratio [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 426
Study Start Date: September 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Family Heart Health Program
Behavioral: 12-week risk reduction program, managed by a Heart Health Educator
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.
No Intervention: 2
Usual Care

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552591

Locations
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
University of Ottawa Heart Institute
Heart and Stroke Foundation of Canada
Investigators
Principal Investigator: Robert D Reid, MBA, PhD University of Ottawa Heart Institute
Study Chair: Andrew L Pipe, MD University of Ottawa Heart Institute
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 University of Ottawa Heart Institute
Study Chair: Louise J Beaton, MSc University of Ottawa Heart Institute
Study Chair: Pat O'Farrell, RN University of Ottawa Heart Institute
Study Chair: Chris M Blanchard, PhD Dalhousie University
Study Chair: Sophia Papadakis, MHA University of Ottawa Heart Institute
Study Chair: Monika Slovinec D'Angelo, PhD University of Ottawa Heart Institute
  More Information

No publications provided by University of Ottawa Heart Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Robert Reid, Principal Investigator, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT00552591     History of Changes
Other Study ID Numbers: NA 6142
Study First Received: November 1, 2007
Last Updated: December 7, 2011
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by University of Ottawa Heart Institute:
family risk
behavior modification
lifestyle change
prevention of CHD
health care costs

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014