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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by University of Toronto.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00787306
First Posted: November 7, 2008
Last Update Posted: July 1, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Toronto
  Purpose
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 fatror control in adults.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multidisciplinary Cariovascular Health And Risk Modification in Family Mealth Teams

Further study details as provided by University of Toronto:

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

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

Estimated Enrollment: 480
Study Start Date: September 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active monitoring
Multi-disciplinary chronic disease management and decision aid intervention
Behavioral: Active risk factor surveillance
Cardiovascualr risk status assessment followed by active surveillance and physician review where risk factor control is suboptimal
No Intervention: Control
Usual care in a wait-list control arm that receives the experimental intervantion after 6 months.
Behavioral: Active risk factor surveillance
Cardiovascualr risk status assessment followed by active surveillance and physician review where risk factor control is suboptimal

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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


Contacts
Contact: Warren J McIsaac, MD 416-586-3190 wmcisaac@mtsinai.on.ca
Contact: Tijana Dragicevic, BSc 416-586-4800 ext 2829 TDragicevic@mtsinai.on.ca

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

Responsible Party: Dr.Warren J. McIsaac, Granovsky Gluskin Family Medicine Centre, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00787306     History of Changes
Other Study ID Numbers: MOH-1048
First Submitted: November 6, 2008
First Posted: November 7, 2008
Last Update Posted: July 1, 2010
Last Verified: June 2010

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

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