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

Status Recruiting

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.

Clinical Trial 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. ;

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

• NCT number: NCT00291824
• Study type: Interventional
• Source: Caroline Medical Group
• Contact: Michael Mills, MD
• Phone: 905.632.8007
• Email: mmills@mcmaster.ca
• Status: Recruiting
• Phase: Phase 1
• Start date: August 2004
• Completion date: February 2006