Vascular DiseaseNCT00236210
A Randomized Controlled Trial of a Novel Community-based Primary and Secondary Cardiovascular Prevention Program
A study testing Action Score and VIP program in people with Vascular Disease and Diabetes, run by Group Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Vascular Disease, Diabetes, Hypertension
- What is being tested?
- Action Score and VIP program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 422 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2004to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Vascular Disease, Diabetes, Hypertension, Hyperlipidemia, Obesity
- Being tested
- Action Score, VIP program
- Keywords
- Vascular Intervention Program, Vascular Disease, Coronary Artery Disease, Diabetes, Lifestyle Modification, Modifiable Risk Factors
- Medical subject headings
- Vascular Diseases, Diabetes Mellitus, Hypertension, Hyperlipidemias, Obesity, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action ScoreBehavioural
Improvement in a novel 100-point score summarizing cardiovascular risk.
VIP programBehavioural
Risk assessment, lifestyle counselling, exercise program
| Study group | Role | What they receive |
|---|---|---|
| VIP program | Active comparator | Risk assessment, lifestyle counselling, exercise program Receives: Behavioral: Action Score; Behavioral: VIP program |
| Standard Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startAug 2004
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Group Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- David Crookston, MD CCFP, Principal investigator, Algoma District Medical Group and Group Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236210
- Sponsor's protocol ID
- Go3-03031
- Status last verified
- Jul 2009
- First submitted
- 7 Oct 2005
- Last updated
- 4 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00236210
- Acronym / sponsor ID
- Go3-03031
- Conditions
- Vascular Disease, Diabetes, Hypertension, Hyperlipidemia, Obesity
- Keywords
- Vascular Intervention Program, Vascular Disease, Coronary Artery Disease, Diabetes, Lifestyle Modification, Modifiable Risk Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Group Health CentreUniversity, hospital or other
- Collaborators
- 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
- Study start
- Aug 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIP program | Active comparator | Behavioral: Action Score, Behavioral: VIP programRisk assessment, lifestyle counselling, exercise program |
| Standard Care | No intervention | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action ScoreImprovement in a novel 100-point score summarizing cardiovascular risk. | Behavioural | VIP program |
| VIP programRisk assessment, lifestyle counselling, exercise program | Behavioural | VIP program |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2009.
- (Group Health Centre website)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crookston, MD CCFP principal investigator
Algoma District Medical Group and Group Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Score and VIP program in people with Vascular Disease and Diabetes, run by Group Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2009.