- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00236210
A Randomized Controlled Trial of a Novel Community-based Primary and Secondary Cardiovascular Prevention Program
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
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Decrease the modifiable risk factors for primary care patients at risk for vascular disease in the Algoma District;
- Increase collaboration between health care providers such as family physicians, pharmacists, physiotherapists, dietitians and nurses in the community;
- Increase the participation of the patient and family in decision-making, self-care, and adherence to agreed-upon management plans;
- Improve patient access to care, clinical outcomes and satisfaction;
- 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Sault Ste. Marie, Ontario, Canada, P6B 1Y5
- Group Health Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard Care
|
|
Active Comparator: VIP program
Risk assessment, lifestyle counselling, exercise program
|
Improvement in a novel 100-point score summarizing cardiovascular risk.
Risk assessment, lifestyle counselling, exercise program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The percentage of patients who attained a significant reduction in their global cardiovascular risk at 6 and 12 months. This was determined a priori by the investigators to be an increase in the ACTION Score of 5 or more.
Time Frame: 6 months and 12 months
|
6 months and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary outcomes were change in the average ACTION Score, change in individual risk domains as measured by the ACTION Score, patient satisfaction, and quality of life, all after 6 months and 12 months, comparing intervention versus control.
Time Frame: 6 months and 12 months
|
6 months and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Crookston, MD CCFP, Algoma District Medical Group and Group Health Centre
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Go3-03031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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