Clinical trial NCT00552591: Family Heart Health Program: Randomized, Controlled Trial
Official title: Family Heart Health Program: Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Keywords: family risk
behavior modification
lifestyle change
prevention of CHD
health care costs
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2007-11-02
Enrollment: 426
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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.

Primary outcomes:
measure: TC/HDL ratio
timeFrame: one year
Secondary outcomes:
measure: Secondary outcomes of interest will include the modifiable components comprising the Framingham score (smoking status, systolic BP, total cholesterol, HDL- and LDL-cholesterol)
timeFrame: 12 weeks and one year
measure: Use of risk reducing medications, use of health care resources, smoking status, leisure time exercise, dietary patterns, and body composition
timeFrame: 12 weeks and one year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Robert D Reid, MBA, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Heart Institute Research Corporation
name: Andrew L Pipe, MD
role: STUDY_CHAIR
affiliation: New York Presbyterian Hospital
name: Lori J Mosca, MD, PhD
role: STUDY_CHAIR
affiliation: New York Presbyterian Hospital
name: Heidi Mochari, MPH, RD
role: STUDY_CHAIR
affiliation: Ottawa Heart Institute Research Corporation
name: George Wells, PhD
role: STUDY_CHAIR
affiliation: Ottawa Heart Institute Research Corporation
name: Louise J Beaton, MSc
role: STUDY_CHAIR
affiliation: Ottawa Heart Institute Research Corporation
name: Pat O'Farrell, RN
role: STUDY_CHAIR
affiliation: Dalhousie University
name: Chris M Blanchard, PhD
role: STUDY_CHAIR
affiliation: Ottawa Heart Institute Research Corporation
name: Sophia Papadakis, MHA
role: STUDY_CHAIR
affiliation: Ottawa Heart Institute Research Corporation
name: Monika Slovinec D'Angelo, PhD
role: STUDY_CHAIR
References:
citation: 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.