Family Heart Health Program: Randomized, Controlled Trial - Full Text View

Purpose

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:

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;
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;
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).

Condition	Intervention
Coronary Heart Disease	Behavioral: 12-week risk reduction program, managed by a Heart Health Educator

MedlinePlus related topics:

Cholesterol Exercise and Physical Fitness Heart Diseases Smoking Smoking Cessation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study

Official Title:	Family Heart Health Program: Randomized, Controlled Trial

Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:

TC/HDL ratio [ Time Frame: one year ]

Secondary Outcome Measures:

Secondary outcomes of interest will include the modifiable components comprising the Framingham score (smoking status, systolic BP, total cholesterol, HDL- and LDL-cholesterol) [ Time Frame: 12 weeks and one year ]
Use of risk reducing medications, use of health care resources, smoking status, leisure time exercise, dietary patterns, and body composition [ Time Frame: 12 weeks and one year ]

Estimated Enrollment:	450
Study Start Date:	September 2007
Estimated Study Completion Date:	June 2010

Arms	Assigned Interventions
1: Experimental Family Heart Health Program	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.
2: No Intervention Usual Care

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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);
Geographically available for assessment, intervention and follow-up.

Exclusion Criteria:

Unable to understand English or French;
History of diabetes mellitus or any atherosclerotic disease;
Fasting glucose ≥ 7.0 mmol/L at screening;
Presence of life threatening illness (e.g., known or suspected cancer or other disease with a life expectancy of less than five years);
Chronic kidney disease and/or undergoing dialysis;
Active liver disease;
Pregnant or planning to become pregnant within the next year;
Cognitive impairment;
Other family member already participating in study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552591

Contacts


Contact: Dana L Riley, MA	613-798-5555 ext 17340	driley@ottawaheart.ca

Contact: Robert D Reid, MBA, PhD	613-761-5058	breid@ottawaheart.ca

Locations


Canada, Ontario
	University of Ottawa Heart Institute	Recruiting
	Ottawa, Ontario, Canada, K1Y 4W7
	Principal Investigator: Robert D Reid, MBA, PhD

Sponsors and Collaborators

University of Ottawa Heart Institute

Heart and Stroke Foundation of Ontario

Investigators


Principal Investigator:	Robert D Reid, MBA, PhD	University of Ottawa Heart Institute

Study Chair:	Andrew L Pipe, MD	University of Ottawa Heart Institute

Study Chair:	Lori J Mosca, MD, PhD	New York Presbyterian Hospital

Study Chair:	Heidi Mochari, MPH, RD	New York Presbyterian Hospital

Study Chair:	George Wells, PhD	University of Ottawa Heart Institute

Study Chair:	Louise J Beaton, MSc	University of Ottawa Heart Institute

Study Chair:	Pat O'Farrell, RN	University of Ottawa Heart Institute

Study Chair:	Chris M Blanchard, PhD	Dalhousie University

Study Chair:	Sophia Papadakis, MHA	University of Ottawa Heart Institute

Study Chair:	Monika Slovinec D'Angelo, PhD	University of Ottawa Heart Institute

More Information

Study ID Numbers:	NA 6142
First Received:	November 1, 2007
Last Updated:	November 1, 2007
ClinicalTrials.gov Identifier:	NCT00552591
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by University of Ottawa Heart Institute:

family risk

behavior modification

lifestyle change

prevention of CHD

health care costs

Study placed in the following topic categories:

Coronary Disease

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Ischemia

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 07, 2008

Sponsors and Collaborators:	University of Ottawa Heart Institute Heart and Stroke Foundation of Ontario
Information provided by:	University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:	NCT00552591