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
1 other identifier
interventional
422
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2004
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedAugust 4, 2009
July 1, 2009
1.9 years
October 7, 2005
July 31, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months and 12 months
Secondary Outcomes (1)
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.
6 months and 12 months
Study Arms (2)
VIP program
ACTIVE COMPARATORRisk assessment, lifestyle counselling, exercise program
Standard Care
NO INTERVENTIONInterventions
Improvement in a novel 100-point score summarizing cardiovascular risk.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Group Health Centrelead
- Ontario Ministry of Health and Long Term Carecollaborator
- McMaster Universitycollaborator
- Coalition for the Acquisition of Sound Habitscollaborator
- Ministry of Northern Development and Mines Youth Internship Programcollaborator
- Pfizercollaborator
Study Sites (1)
Group Health Centre
Sault Ste. Marie, Ontario, P6B 1Y5, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Crookston, MD CCFP
Algoma District Medical Group and Group Health Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
August 1, 2004
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
August 4, 2009
Record last verified: 2009-07