Family Heart Health Program: Randomized, Controlled Trial
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      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).
    


Intervention name(s): 12-week risk reduction program, managed by a Heart Health Educator
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: family risk; behavior modification; lifestyle change; prevention of CHD; health care costs