Cardiovascular Risk FactorsPhase 3Multi-CHARMNCT00787306
Cardiovascular Health And Risk Modification in Family Health Teams
A Phase 3 study testing Active risk factor surveillance in people with Cardiovascular Risk Factors and Hypertension, run by University of Toronto at 1 site in Canada.
Trial summary
Cardiovascular diseases remain the main cause of mortality in Canada. While effective interventions are available for reducing the risk of cardiovascular disease,there continue to be gaps between the potential reduction in risk that could be achieved by effectively managing these risk factors and levels of risk factor… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors, Hypertension, Hyperlipidemia
- What is being tested?
- Active risk factor surveillance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2008to Jun 2009
- Phase
- Phase 3
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults 50 to 80 years of age
- having attending a family medicine clinic for more than one year
Who cannot join
- not able to participate for one year
- not able to read English
- requires house calls
- nursing home resident
- cognitive impairment
- current chest pain or symptoms of active coronary heart disease
Trial locations and contacts
1 site in 1 country.
Canada1 site
Granovsky Gluskin Family Medicine Cwntre
Toronto, Ontario, M5T 3L9
About this study
Official title: Multidisciplinary Cardiovascular Health And Risk Modification in Family Health Teams
Cardiovascular diseases remain the main cause of mortality in Canada. While effective interventions are available for reducing the risk of cardiovascular disease,there continue to be gaps between the potential reduction in risk that could be achieved by effectively managing these risk factors and levels of risk factor control currently in clinical practice. This study will evaluate the ability of a different model of risk factor care using other health providers assisting family doctors, along with information aids for patients and health professionals,to achieve better levels of cardiovascular risk factor control in adults.
- Conditions
- Cardiovascular Risk Factors, Hypertension, Hyperlipidemia, Diabetes
- Being tested
- Active risk factor surveillance
- Keywords
- chronic disease management, decision aids, cardiovascular risk factors
- Medical subject headings
- Hypertension, Hyperlipidemias, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active risk factor surveillanceBehavioural
Cardiovascular risk status assessment followed by active surveillance and physician review where risk factor control is suboptimal
| Study group | Role | What they receive |
|---|---|---|
| Multi-faceted Cardiovascular Decision Support | Experimental | Risk factor active surveillance, multi-disciplinary disease management and decision aid intervention Receives: Behavioral: Active risk factor surveillance |
| Control Usual Care | Other | Usual care in a wait-list control arm that receives the experimental intervention after 6 months. Receives: Behavioral: Active risk factor surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean systolic blood pressure
Measured: 6 months
Secondary outcomes (1)
Proportion of adults with 3 cardiovascular risk factors under optimal control
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Warren McIsaac, University of Toronto
- Investigators
- Warren J McIsaac, MD, Principal investigator, Granovsky Gluskin Family Medicine Centre, Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787306
- Sponsor's protocol ID
- MOH-1048
- Acronym
- Multi-CHARM
- Status last verified
- Mar 2018
- First submitted
- 6 Nov 2008
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Cardiovascular Health And Risk Modification in Family Health Teams
- ClinicalTrials.gov ID
- NCT00787306
- Acronym / sponsor ID
- Multi-CHARM / MOH-1048
- Conditions
- Cardiovascular Risk Factors, Hypertension, Hyperlipidemia, Diabetes
- Keywords
- chronic disease management, decision aids, cardiovascular risk factors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 7 Nov 2008 (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.
Cardiovascular diseases remain the main cause of mortality in Canada. While effective interventions are available for reducing the risk of cardiovascular disease,there continue to be gaps between the potential reduction in risk that could be achieved by effectively managing these risk factors and levels of risk factor control currently in clinical practice. This study will evaluate the ability of a different model of risk factor care using other health providers assisting family doctors, along with information aids for patients and health professionals,to achieve better levels of cardiovascular risk factor control in adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-faceted Cardiovascular Decision Support | Experimental | Behavioral: Active risk factor surveillanceRisk factor active surveillance, multi-disciplinary disease management and decision aid intervention |
| Control Usual Care | Other | Behavioral: Active risk factor surveillanceUsual care in a wait-list control arm that receives the experimental intervention after 6 months. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults 50 to 80 years of age
- having attending a family medicine clinic for more than one year
Key exclusion criteria (6 listed)
- not able to participate for one year
- not able to read English
- requires house calls
- nursing home resident
- cognitive impairment
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 |
|---|---|---|
| Active risk factor surveillanceCardiovascular risk status assessment followed by active surveillance and physician review where risk factor control is suboptimal | Behavioural | Control Usual Care, Multi-faceted Cardiovascular Decision Support |
Primary outcome
mean systolic blood pressure
Time frame: 6 months
1 secondary outcome
Proportion of adults with 3 cardiovascular risk factors under optimal control
Time frame: 6 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 3 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Warren J McIsaac, MD principal investigator
Granovsky Gluskin Family Medicine Centre, Mount Sinai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active risk factor surveillance in people with Cardiovascular Risk Factors and Hypertension, run by University of Toronto 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 2 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 3 Apr 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
mean systolic blood pressure (time frame: 6 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 3 Apr 2018.