Family Heart Health Program: Randomized, Controlled Trial

Coronary Heart Disease Clinical Trial

— FHHP-RCT  

Official title:

Family Heart Health Program: Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552591
• Other study ID #: NA 6142
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Est. completion date: September 2011

Study information

• Verified date: February 2022
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TC/HDL ratio		one year
Secondary	Secondary outcomes of interest will include the modifiable components comprising the Framingham score (smoking status, systolic BP, total cholesterol, HDL- and LDL-cholesterol)		12 weeks and one year
Secondary	Use of risk reducing medications, use of health care resources, smoking status, leisure time exercise, dietary patterns, and body composition		12 weeks and one year