Cardiovascular Lifestyle Study: Effects and Expense of a Cardiovascular Risk Reduction Clinic in Primary Care

Hypertension Clinical Trial

Official title:

A Randomized Controlled Trial of the Effects and Expense of a Primary and Secondary Cardiovascular Risk Reduction Clinic in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00291824
• Other study ID #: PHCTF G03-02656
• Status: Recruiting
• Phase: Phase 1
• First received: February 13, 2006
• Last updated: February 13, 2006
• Start date: August 2004
• Est. completion date: February 2006

Study information

• Verified date: February 2006
• Source: Caroline Medical Group
• Contact: Michael Mills, MD
• Phone: 905.632.8007
• Email: mmills[@]mcmaster.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to study the effects on risk reduction and expense of 3 approaches to the care of people with cardiovascular risk factors in a naturalistic primary care environment.

Description:

Background: Uncontrolled hypertension, hyperlipidemia, hyperglycemia, smoking and other cardiovascular risks remain at epidemic proportions despite known efficacious treatments. Issues of both provider and patient behavioral non-adherence to guidelines and therapeutic regimes, respectively, are key factors in non-control. Few interventions aimed at reducing cardiovascular risk factors are based on sound theories of behavior change.

Objective: To assess the effectiveness and expense of three approaches to the care of persons with known risks for cardiovascular disease. The three treatment approaches are usual care, usual care plus nurse telephone calls, and usual care plus clinic visits to a nurse and/or physician.

Design: Patients will be randomized to a 1) specialized proactive, and holistic cardiovascular risk management clinic using principles of behavior change; 2) nurse telephone calls as an attention placebo, yet a low dose, health promotion intervention; and 3) usual primary care. A random sample of 670 patients with cardiovascular risks identified in the past five years will be selected. Patients will be excluded if they do not speak English, are cognitively impaired or live in a nursing home. Interview questionnaires will measure cardiovascular risk, intention to change, social support, depression, coping and health services use. In addition, patients will be required to give a blood sample to measure cholesterol and glucose levels. Patients will then be randomized to one of three treatment groups.

Significance: The expected findings of this study is that the cardiovascular clinic, with nurse and physician, will be most effective at reducing cardiovascular risk and will pay for itself by averting hospital and emergency use for cardiovascular events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 670
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• A random sample of all persons with visits to their primary care physician for cardiovascular risks in past year. Cognitively intact (mini-mental state) or living with a carer who is cognitively intact. All other co-morbidities

Exclusion Criteria:

• Presently in a nursing home or in-patient long-term care facility (already receiving medications and diets as prescribed). No available family/friend interpreter if non-English speaking.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hyperglycemia
• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Smoking

Intervention

Behavioral:
• Cardiovascular risk factors and willingness to change

Locations

Country	Name	City	State
Canada	Caroline Medical Group	Burlington	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Caroline Medical Group	Health Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Current Interview or Chart
Primary	International classification of diseases
Primary	Characteristics/demographics (dob, gender, marital status, living arrangement, employment, culture, language, spiritual beliefs, concurrent diseases - number/type).
Primary	Cognition: 10 item short portable mental status questionnaire (SPMSQ)(Pfeiffer, 1975)
Primary	Number of MD visits for cardiovascular risk factor
Primary	Percentage change in cardiovascular risk scores over time.
Primary	Percentage of targeted weight and exercise goals achieved (blood pressure control, smoking cessation, weight control, cholesterol control, sugar control, exercise levels). (Grundy, et al, 1999)
Primary	Self efficacy scale (Lorig et al, 1996)
Primary	Social support - personal resource questionnaire 85 (Weinert & Brandt 1987).
Primary	Depression (MADRS)(Montgomery & Asberg 1979) (Montgomery et al 1985) (Browne, Steiner Roberts et al 2002).
Primary	Coping (Moos and Billings 1984)
Primary	Expenditures of health and social services (Browne et al 2001)
Primary	Calculate the number of Framingham points for each risk factor
Primary	Blood samples
Primary	Counselling
Primary	Education
Secondary	Motivational Interviewing
Secondary	Behavior Change