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

NCT00291824 | Unknown Phase 1

• 1 other identifier: PHCTF G03-02656
• Study Type: interventional
• Target: 670
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Hyperlipidemia; Hyperglycemia; Cardiovascular Disease; Smoking

Keywords

Cardiovascular risks; Motivational interviewing; Behavior change; Primary care setting

Outcome Measures

Primary Outcomes (16)

• Current Interview or Chart

• International classification of diseases

• Characteristics/demographics (dob, gender, marital status, living arrangement, employment, culture, language, spiritual beliefs, concurrent diseases - number/type).

• Cognition: 10 item short portable mental status questionnaire (SPMSQ)(Pfeiffer, 1975)

• Number of MD visits for cardiovascular risk factor

• Percentage change in cardiovascular risk scores over time.

• 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)

• Self efficacy scale (Lorig et al, 1996)

• Social support - personal resource questionnaire 85 (Weinert & Brandt 1987).

• Depression (MADRS)(Montgomery & Asberg 1979) (Montgomery et al 1985) (Browne, Steiner Roberts et al 2002).

• Coping (Moos and Billings 1984)

• Expenditures of health and social services (Browne et al 2001)

• Calculate the number of Framingham points for each risk factor

• Blood samples

• Counselling

• Education

Secondary Outcomes (2)

• Motivational Interviewing

• Behavior Change

Interventions

Cardiovascular risk factors and willingness to change BEHAVIORAL

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Caroline Medical Group: lead
• Health Canada: collaborator

Study Sites (1)

Caroline Medical Group

Burlington, Ontario, L7R4C7, Canada

RECRUITING

MeSH Terms

Conditions

Hypertension; Hyperlipidemias; Hyperglycemia; Cardiovascular Diseases; Smoking

Interventions

Heart Disease Risk Factors

Condition Hierarchy (Ancestors)

Vascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Behavior

Intervention Hierarchy (Ancestors)

Risk Factors; Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Michael Mills, MD CCFP

  Caroline Medical Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Mills, MD

CONTACT

905.632.8007; mmills@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 13, 2006
• First Posted: February 15, 2006
• Study Start: August 1, 2004
• Study Completion: February 1, 2006
• Last Updated: February 15, 2006

Record last verified: 2006-02

Locations

CA (1)