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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Caroline Medical Group.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Health Canada
Information provided by:
Caroline Medical Group
ClinicalTrials.gov Identifier:
NCT00291824
First received: February 13, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  Purpose

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 Intervention Phase
Hypertension
Hyperlipidemia
Hyperglycemia
Cardiovascular Disease
Smoking
Behavioral: Cardiovascular risk factors and willingness to change
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Caroline Medical Group:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Motivational Interviewing
  • Behavior Change

Estimated Enrollment: 670
Study Start Date: August 2004
Estimated Study Completion Date: February 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291824

Contacts
Contact: Michael Mills, MD 905.632.8007 mmills@mcmaster.ca

Locations
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
Investigators
Principal Investigator: Michael Mills, MD CCFP Caroline Medical Group
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00291824     History of Changes
Other Study ID Numbers: PHCTF G03-02656
Study First Received: February 13, 2006
Last Updated: February 13, 2006
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperglycemia
Hyperlipidemias
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014