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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00787306
First received: November 6, 2008
Last updated: June 30, 2010
Last verified: June 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Multidisciplinary Cariovascular Health And Risk Modification in Family Mealth Teams

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • mean systolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of adults with 3 CV risk factors under optimal control [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 6, 2008
Last Updated: June 30, 2010
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013