CVD Risk Reduction Trial

Cardiovascular Disease Clinical Trial

— COHRT  

Official title:

Community Outreach Heart Health and Risk Reduction Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473785
• Other study ID #: HSFO4857
• Secondary ID: HSFO Grant # 485
• Status: Completed
• Phase: N/A
• First received: May 11, 2007
• Last updated: May 14, 2007
• Start date: January 2002
• Est. completion date: December 2005

Study information

• Verified date: May 2007
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to provide lifestyle counselling for protective health behavior (exercise, diet, smoking cessation) to small groups (6-8 subjects) via teleconference. The sample includes individuals at elevated risk for cardiovascular disease (CVD) as well as individuals with established CVD. Our hypothesis is that telephone-based lifestyle counselling will (1) significantly increase protective lifestyle behavior (diet, exercise, smoke-free living) and (2) significantly reduce CVD risk factors at 6-month follow-up.

Description:

COHRT was a 2 parallel-group randomized controlled trial that was designed to assess the efficacy of a community outreach strategy for cardiovascular disease (CVD) risk reduction among individuals at elevated risk for CV events. Randomization was stratified for diagnosis of CHD, type 1 or 2 diabetes, sex, and clinical depression, and blocked within our northern, rural, and urban recruitment sites. A 2X3 mixed factorial design was utilized: 2 Groups (Usual Care, UC/Lifestyle Counselling,LC) X 3 Intervals (Baseline, post-treatment, 6-month follow-up). All subjects received personal CVD risk factor feedback and standardized handouts on heart healthy lifestyle change. The LC group received 6 weekly 1-hour sessions of lifestyle counseling that was provided via teleconference in small groups (4-8 persons). Group facilitators were trained in a manualized protocol of motivational interviewing that was designed for CVD risk reduction through lifestyle change. Weekly supervision was also provided. We hypothesized that the LC group (vs. UC) would significantly increase protective health behavior (exercise, diet, smoke-free living) at post-treatment and 6-month follow-up. The secondary hypothesis was that LC would significantly reduce (1) CVD risk factors, (SBP, DBP, total cholesterol, LDL cholesterol), (2) 10-year absolute risk among subjects without CVD, and (3) significantly increase quality of life as measured by symptoms of depression, psychological stress, and social support.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 827
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 74 Years

Eligibility

Inclusion Criteria:

• 35 to 74 years of age,

• Diagnosis of CVD or Type 1 or 2 diabetes, or

• =2 of the following CVD risk factors:

• Confirmed diagnosis of hypertension,

• Dyslipidemia,

• Males aged =55 years/females aged =60 years,

• Family history of CHD or stroke;

• Current smoker, or

• BMI = 27.

Exclusion Criteria:

• Diagnosis of clinically significant cardiac complications (e.g. arrhythmia, unstable angina) or a congenital cardiac condition;

• Major psychiatric illness (e.g. psychosis), history of alcohol or drug dependence within the previous year, or residence in a non-private setting.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• Group-based motivational interviewing

• Individual CVD-risk factor feedback

• Education for protective health behavior change

Locations

Country	Name	City	State
Canada	Grey-Bruce Health Unit	Owen Sound	Ontario
Canada	Laurentian University / Sudbury and District Health Unit	Sudbury	Ontario
Canada	University Health Network / Sunnybrook and Women's College Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Grace SL, Barry-Bianchi S, Stewart DE, Rukholm E, Nolan RP. Physical activity behavior, motivational readiness and self-efficacy among Ontarians with cardiovascular disease and diabetes. J Behav Med. 2007 Feb;30(1):21-9. Epub 2006 Nov 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychometric assessment of change in exercise, diet and smoking		Post-treatment and 6-month follow-up
Secondary	SBP, DBP, total cholesterol, HDL, LDL, triglycerides and 10-year absolute CVD risk		6-month follow-up
Secondary	Psychometric assessment of symptoms of depression, psychological stress, and social support.		post-treatment and 6-month follow-up