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Cardiovascular Health And Risk Modification in Family Health Teams (Multi-CHARM)

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ClinicalTrials.gov Identifier: NCT00787306
Recruitment Status : Completed
First Posted : November 7, 2008
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Warren McIsaac, University of Toronto

Brief 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 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factors Hypertension Hyperlipidemia Diabetes Behavioral: Active risk factor surveillance Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multidisciplinary Cardiovascular Health And Risk Modification in Family Health Teams
Study Start Date : October 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
Experimental: Multi-faceted Cardiovascular Decision Support
Risk factor active surveillance, multi-disciplinary disease management and decision aid intervention
Behavioral: Active risk factor surveillance
Cardiovascular risk status assessment followed by active surveillance and physician review where risk factor control is suboptimal
Control Usual Care
Usual care in a wait-list control arm that receives the experimental intervention after 6 months.
Behavioral: Active risk factor surveillance
Cardiovascular risk status assessment followed by active surveillance and physician review where risk factor control is suboptimal



Primary Outcome Measures :
  1. mean systolic blood pressure [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Proportion of adults with 3 cardiovascular risk factors under optimal control [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults 50 to 80 years of age
  • having attending a family medicine clinic for more than one year

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00787306


Locations
Canada, Ontario
Granovsky Gluskin Family Medicine Cwntre
Toronto, Ontario, Canada, M5T 3L9
Sponsors and Collaborators
University of Toronto
Investigators
Principal Investigator: Warren J McIsaac, MD Granovsky Gluskin Family Medicine Centre, Mount Sinai Hospital

Responsible Party: Warren McIsaac, Associate Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT00787306     History of Changes
Other Study ID Numbers: MOH-1048
First Posted: November 7, 2008    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Warren McIsaac, University of Toronto:
chronic disease management
decision aids
cardiovascular risk factors

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases