Family Heart Health Program: Randomized, Controlled Trial

NCT ID: NCT00552591

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 426 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2011-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Family Heart Health Program

Group Type: EXPERIMENTAL

12-week risk reduction program, managed by a Heart Health Educator

Intervention Type: BEHAVIORAL

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.

2

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heart and Stroke Foundation of Canada

OTHER

Sponsor Role: collaborator

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert D Reid, MBA, PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Andrew L Pipe, MD

Role: STUDY_CHAIR

Ottawa Heart Institute Research Corporation

Lori J Mosca, MD, PhD

Role: STUDY_CHAIR

New York Presbyterian Hospital

Heidi Mochari, MPH, RD

Role: STUDY_CHAIR

New York Presbyterian Hospital

George Wells, PhD

Role: STUDY_CHAIR

Ottawa Heart Institute Research Corporation

Louise J Beaton, MSc

Role: STUDY_CHAIR

Ottawa Heart Institute Research Corporation

Pat O'Farrell, RN

Role: STUDY_CHAIR

Ottawa Heart Institute Research Corporation

Chris M Blanchard, PhD

Role: STUDY_CHAIR

Dalhousie University

Sophia Papadakis, MHA

Role: STUDY_CHAIR

Ottawa Heart Institute Research Corporation

Monika Slovinec D'Angelo, PhD

Role: STUDY_CHAIR

Ottawa Heart Institute Research Corporation

Locations

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 24246588 (View on PubMed)

Other Identifiers

NA 6142

Identifier Type: -

Identifier Source: org_study_id