A Randomized Controlled Trial of a Novel Community-based Primary and Secondary Cardiovascular Prevention Program

NCT00236210

Last updated date
Study Location
Group Health Centre
Sault Ste. Marie, Ontario, P6B 1Y5, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vascular Disease, Diabetes, Hypertension, Hyperlipidemia, Obesity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men >30 years of age

- Women > 40 years of age

- History of vascular disease (as defined in Study Design, page 8)

- Framingham Risk Score >/= 12 %

- Capable of giving informed consent

- Ability and willingness to complete questionnaires and have study procedures done

- Willingness to belong to either the intervention or standard care arm

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- FRS <12% (low risk) -- enrolled into the cohort arm (not randomized. Follow-up at
study end only.)


- Any condition that will prevent the patient from participating in and completing the
study


- Unable to come to the Group Health Centre for appointments


- Any factor likely to limit protocol compliance


- Unwilling to permit VIP staff to contact their primary physicians to communicate
information about the study and the participant's data and treatment assignment


- Previous randomization into this study

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Vascular Disease, Diabetes, Hypertension, Hyperlipidemia, ObesityA Randomized Controlled Trial of a Novel Community-based Primary and Secondary Cardiovascular Prevention Program
NCT00236210
  1. Sault Ste. Marie, Ontario
ALL GENDERS
30 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Trial of a Novel Community-based Primary and Secondary Cardiovascular Prevention Program
Official Title  ICMJE The Vascular Intervention Project (VIP): a Randomized Controlled Trial of a Novel Community-based Primary and Secondary Cardiovascular Prevention Program in the Algoma District of Northern Ontario
Brief Summary VIP is a demonstration project with a goal to decrease modifiable risk factors for those with a higher risk of having a vascular event such as a heart attack or stroke or of developing vascular disease. Introduced as a study, VIP compares whether there is a significant reduction of modifiable vascular risk factors among patients who are involved in a personalized directed program versus those being provided standard care by their physician. Health care providers work collaboratively with the 'VIP Team' to improve the participants' vascular health.
Detailed Description

This Northern Ontario, community-based demonstration project is a multi-disciplinary, primary care provider-based collaboration. The goals of the project are to:

  1. Decrease the modifiable risk factors for primary care patients at risk for vascular disease in the Algoma District;
  2. Increase collaboration between health care providers such as family physicians, pharmacists, physiotherapists, dietitians and nurses in the community;
  3. Increase the participation of the patient and family in decision-making, self-care, and adherence to agreed-upon management plans;
  4. Improve patient access to care, clinical outcomes and satisfaction;
  5. Provide a business case for a practical, sustainable and generalizable model for the primary care of vascular disease in the community.

The Group Health Centre, a multi-disciplinary, not-for-profit community-based health organization with 56,000 rostered patients, leads the project. However, all Sault Ste Marie community patients are eligible to join the Vascular Intervention Program (VIP). This program has three key components: a registry of VIP patients with audit, recall and feedback; use of the novel ACTION score template, and the optional use of VIPNet, a personalized patient record tool that provides secure web access to optimize quality and continuity of care. The VIP project aims to empower patients and increase collaboration among the primary health care team. Patients with any vascular risk factors will be eligible for VIP.

The VIP project is a demonstration project that does not duplicate existing GHC chronic disease management programs because (1) the VIP is offered to all eligible community patients, not only GHC enrollees; (2) VIP integrates any patients with vascular risk, not just those with pre-defined conditions; (3) novel collaborative tools such as the ACTION template and VIPNet website are being piloted; and (4) explicit patient-centred decision making drives the process. The development and evaluation of the VIP demonstration project is a unique step in the evolution of primary care chronic disease management in Sault Ste Marie, and the rest of the province.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Vascular Disease
  • Diabetes
  • Hypertension
  • Hyperlipidemia
  • Obesity
Intervention  ICMJE
  • Behavioral: Action Score
    Improvement in a novel 100-point score summarizing cardiovascular risk.
  • Behavioral: VIP program
    Risk assessment, lifestyle counselling, exercise program
Study Arms  ICMJE
  • Active Comparator: VIP program
    Risk assessment, lifestyle counselling, exercise program
    Interventions:
    • Behavioral: Action Score
    • Behavioral: VIP program
  • No Intervention: Standard Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2009)
422
Original Enrollment  ICMJE
 (submitted: October 7, 2005)
1600
Actual Study Completion Date  ICMJE July 2006
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men >30 years of age
  • Women > 40 years of age
  • History of vascular disease (as defined in Study Design, page 8)
  • Framingham Risk Score >/= 12 %
  • Capable of giving informed consent
  • Ability and willingness to complete questionnaires and have study procedures done
  • Willingness to belong to either the intervention or standard care arm

Exclusion Criteria:

  • FRS <12% (low risk) -- enrolled into the cohort arm (not randomized. Follow-up at study end only.)
  • Any condition that will prevent the patient from participating in and completing the study
  • Unable to come to the Group Health Centre for appointments
  • Any factor likely to limit protocol compliance
  • Unwilling to permit VIP staff to contact their primary physicians to communicate information about the study and the participant's data and treatment assignment
  • Previous randomization into this study
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00236210
Other Study ID Numbers  ICMJE Go3-03031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. David Crookston, Group Health Centre
Study Sponsor  ICMJE Group Health Centre
Collaborators  ICMJE
  • Ontario Ministry of Health and Long Term Care
  • McMaster University
  • Coalition for the Acquisition of Sound Habits
  • Ministry of Northern Development and Mines Youth Internship Program
  • Pfizer
Investigators  ICMJE
Principal Investigator:David Crookston, MD CCFPAlgoma District Medical Group and Group Health Centre
PRS Account Group Health Centre
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP