Recruiting
Phase 1

Cardiovascular Lifestyle

Sponsor:

Caroline Medical Group

Code:

NCT00291824

Conditions

Hypertension

Hyperlipidemia

Hyperglycemia

Cardiovascular Disease

Smoking

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Cardiovascular risk factors and willingness to change

Study Details

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

Study ID

NCT00291824

Start date

Aug, 2004

Status verified date

Feb, 2006

Completion date

Feb, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

670 participants

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Interventions

Cardiovascular risk factors and willingness to change

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Michael Mills, MD

905.632.8007mmills@mcmaster.ca

Locations

Caroline Medical Group

Recruiting

Burlington, Ontario, Canada, L7R4C7

Contacts

Donna Landry

905.632.8007

More Information

Sponsor

Caroline Medical Group

Last update posted

Feb 15, 2006

Last verified

Feb, 2006

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Caroline Medical Group on 2006-02-15.