Family Heart Health Program: Randomized, Controlled Trial

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).

Conditions

• Coronary Heart Disease

Interventions

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.

Sponsors & Collaborators

• Heart and Stroke Foundation of Canada

  collaborator OTHER

• Ottawa Heart Institute Research Corporation

  lead OTHER

Principal Investigators

• Robert D Reid, MBA, PhD · Ottawa Heart Institute Research Corporation

• Andrew L Pipe, MD · Ottawa Heart Institute Research Corporation

• Lori J Mosca, MD, PhD · New York Presbyterian Hospital

• Heidi Mochari, MPH, RD · New York Presbyterian Hospital

• George Wells, PhD · Ottawa Heart Institute Research Corporation

• Louise J Beaton, MSc · Ottawa Heart Institute Research Corporation

• Pat O'Farrell, RN · Ottawa Heart Institute Research Corporation

• Chris M Blanchard, PhD · Dalhousie University

• Sophia Papadakis, MHA · Ottawa Heart Institute Research Corporation

• Monika Slovinec D'Angelo, PhD · Ottawa Heart Institute Research Corporation

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-09-30

Primary Completion

2011-09-30

Completion

2011-09-30

Countries

• Canada

Study Locations