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Diabetes IN-CHARGE: Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation
This study is currently recruiting participants.
Verified by McMaster University, November 2007
Sponsors and Collaborators: Hamilton Health Sciences
Canadian Institutes of Health Research (CIHR)
Information provided by: McMaster University
ClinicalTrials.gov Identifier: NCT00182026
  Purpose

The purpose of this study is to test whether providing personalized diabetes self-management recommendations and feedback improves blood sugar control more than providing generalized diabetes educational material alone.


Condition Intervention
Diabetes Mellitus, Type 2
Behavioral: personal feedback report

MedlinePlus related topics: Diabetes
Drug Information available for: Dextrose
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Randomized Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation: Diabetes IN-CHARGE

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • A1c [ Time Frame: 6 months and 1 year ]

Secondary Outcome Measures:
  • diabetes-related self-care behaviours, drug use, clinical outcomes [ Time Frame: 6 months and 1 year ]
  • diabetes-specific quality of life [ Time Frame: 1 year ]
  • incremental cost/quality-adjusted life-year [QALY] [ Time Frame: 6 months and 1 year ]

Estimated Enrollment: 500
Study Start Date: June 2005
Estimated Study Completion Date: December 2008
Detailed Description:

Diabetes mellitus (DM) is a common chronic disease that is rapidly rising in prevalence, affecting upwards of 35,000 adults in the Hamilton, Ontario region (population 400,000). The magnitude and growth of the problem and its serious health consequences suggest that:

  1. diabetes is now a major public health problem; and
  2. interventions at the community level are needed to mitigate its health impact.

During the last 5 years, Diabetes Hamilton was successfully piloted as a free community-based program available to anyone with diabetes. It promotes diabetes self-management, self-efficacy and awareness through the provision of generalized diabetes information (e.g. newsletters, workshops, forums, resource directories) to consumers, local physicians and other health professionals.

This trial will determine if supplementing Diabetes Hamilton with an automated tailored feedback system that:

  1. provides information;
  2. generates and communicates specific evidence-based recommendations to users from a self-administered questionnaire;
  3. copies this communication to the patient's designated physician;
  4. facilitates access to community resources; and
  5. provides a simple way for the patient to track changes in indicators of health can improve A1c and other diabetes care indicators more than Diabetes Hamilton alone.
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 2 diabetes of 1 or more years duration
  • Health insurance coverage within Ontario
  • Ages 40 or older
  • Registered in, or willing to register in Diabetes Hamilton
  • Able to read and understand English and provide informed consent in English
  • Have home access to either mail, e-mail or the internet
  • Have a baseline A1c >= 7%

Exclusion Criteria:

  • Current pregnancy
  • Residence in an institution that provides diabetes care
  • Cohabiting with study participant
  • Residence outside the city of Hamilton
  • Inability to read or understand English
  • Inability/unwillingness to sign the informed consent or comply with protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182026

Contacts
Contact: Janet L Greb, MPA(HSA) 905-525-9140 ext 22359 grebj@mcmaster.ca

Locations
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Janet L Greb, MPA(HSA)     905-525-9140 ext 22359     grebj@mcmaster.ca    
Principal Investigator: Hertzel C Gerstein, MD, MSc            
Sub-Investigator: Dereck L Hunt, MD, MSc            
Sub-Investigator: Robert B Haynes, MD, MSc, PhD            
Sub-Investigator: William L Harper, BSc, MD            
Sub-Investigator: Sarah E Capes, MD, MSc            
Sub-Investigator: Ron A Goeree, BA, MA            
Sub-Investigator: Anne M Holbrook, PhrmD MD MSc            
Sub-Investigator: Gina Agarwal, MBBS, MSc            
Sponsors and Collaborators
Hamilton Health Sciences
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Hertzel C Gerstein, MD MSc FRCPC McMaster University
  More Information

Official web site of the Diabetes Hamilton program  This link exits the ClinicalTrials.gov site

Study ID Numbers: MCT-68786
Study First Received: September 9, 2005
Last Updated: November 8, 2007
ClinicalTrials.gov Identifier: NCT00182026  
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
diabetes
community intervention
self-management
prevention

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 15, 2009