Family Heart Health Program: Randomized, Controlled Trial (FHHP-RCT)

University of Ottawa Heart Institute

Status: Completed

Conditions: Coronary Heart Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00552591

NA 6142

Details and patient eligibility

About

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).

Enrollment: 426 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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426 participants in 2 patient groups

1

Experimental group

Description:

Family Heart Health Program

Treatment:

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

2

No Intervention group

Description:

Usual Care