Family Heart Health Program: Randomized, Controlled Trial

Not Applicable

Completed

• Conditions: Coronary Heart Disease
• Interventions: Behavioral: 12-week risk reduction program, managed by a Heart Health Educator

• Registration Number: NCT00552591
• Lead Sponsor: Ottawa Heart Institute Research Corporation

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-11-01
• Study First Submitted QC: 2007-11-01
• Study First Posted: 2007-11-02
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-24
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 426

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	12-week risk reduction program, managed by a Heart Health Educator	Family Heart Health Program

Primary Outcome Measures

Name	Time	Method
TC/HDL ratio	one year

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada