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

November 1, 2007
December 7, 2011
September 2007
September 2011   (final data collection date for primary outcome measure)
TC/HDL ratio [ Time Frame: one year ] [ Designated as safety issue: No ]
TC/HDL ratio [ Time Frame: one year ]
Complete list of historical versions of study NCT00552591 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Family Heart Health Program: Randomized, Controlled Trial
Family Heart Health Program: Randomized, Controlled Trial

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).
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Coronary Heart Disease
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.
  • Experimental: 1
    Family Heart Health Program
    Intervention: Behavioral: 12-week risk reduction program, managed by a Heart Health Educator
  • No Intervention: 2
    Usual Care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
426
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00552591
NA 6142
No
Dr Robert Reid, University of Ottawa Heart Institute
Ottawa Heart Institute Research Corporation
Heart and Stroke Foundation of Canada
Principal Investigator: Robert D Reid, MBA, PhD Ottawa Heart Institute Research Corporation
Study Chair: 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: Monika Slovinec D'Angelo, PhD Ottawa Heart Institute Research Corporation
Ottawa Heart Institute Research Corporation
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP