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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00291824
Recruitment Status : Unknown
Verified February 2006 by Caroline Medical Group.
Recruitment status was:  Recruiting
First Posted : February 15, 2006
Last Update Posted : February 15, 2006
Health Canada
Information provided by:
Caroline Medical Group

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.

Condition or disease Intervention/treatment Phase
Hypertension Hyperlipidemia Hyperglycemia Cardiovascular Disease Smoking Behavioral: Cardiovascular risk factors and willingness to change Phase 1

Detailed 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 Type : Interventional  (Clinical Trial)
Enrollment : 670 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of the Effects and Expense of a Primary and Secondary Cardiovascular Risk Reduction Clinic in Primary Care
Study Start Date : August 2004
Study Completion Date : February 2006

Primary Outcome Measures :
  1. Current Interview or Chart
  2. International classification of diseases
  3. Characteristics/demographics (dob, gender, marital status, living arrangement, employment, culture, language, spiritual beliefs, concurrent diseases - number/type).
  4. Cognition: 10 item short portable mental status questionnaire (SPMSQ)(Pfeiffer, 1975)
  5. Number of MD visits for cardiovascular risk factor
  6. Percentage change in cardiovascular risk scores over time.
  7. 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)
  8. Self efficacy scale (Lorig et al, 1996)
  9. Social support - personal resource questionnaire 85 (Weinert & Brandt 1987).
  10. Depression (MADRS)(Montgomery & Asberg 1979) (Montgomery et al 1985) (Browne, Steiner Roberts et al 2002).
  11. Coping (Moos and Billings 1984)
  12. Expenditures of health and social services (Browne et al 2001)
  13. Calculate the number of Framingham points for each risk factor
  14. Blood samples
  15. Counselling
  16. Education

Secondary Outcome Measures :
  1. Motivational Interviewing
  2. Behavior Change

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00291824

Contact: Michael Mills, MD 905.632.8007

Canada, Ontario
Caroline Medical Group Recruiting
Burlington, Ontario, Canada, L7R4C7
Contact: Michael Mills, MD CCFP         
Contact: Donna Landry    905.632.8007 ext 103      
Sub-Investigator: Lori Chalklin, MD CCFP         
Sub-Investigator: David Wallik, MD CCFP         
Sub-Investigator: James Kraemer, MD CCFP         
Sub-Investigator: Stephen Duncan, MD CCFP         
Sub-Investigator: Chris Williams, MD CCFP         
Sponsors and Collaborators
Caroline Medical Group
Health Canada
Principal Investigator: Michael Mills, MD CCFP Caroline Medical Group Identifier: NCT00291824     History of Changes
Other Study ID Numbers: PHCTF G03-02656
First Posted: February 15, 2006    Key Record Dates
Last Update Posted: February 15, 2006
Last Verified: February 2006

Keywords provided by Caroline Medical Group:
Cardiovascular risks
Motivational interviewing
Behavior change
Primary care setting

Additional relevant MeSH terms:
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Glucose Metabolism Disorders