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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00291824
Other study ID # PHCTF G03-02656
Secondary ID
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
Est. primary completion date
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


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
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