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Diabetes IN-CHARGE: Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation

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ClinicalTrials.gov Identifier: NCT00182026
Recruitment Status : Unknown
Verified February 2009 by McMaster University.
Recruitment status was:  Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : October 8, 2010
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: personal feedback report Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation: Diabetes IN-CHARGE
Study Start Date : June 2005
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Intervention Details:
    Behavioral: personal feedback report
    A computer-generated feedback report that provides personalized diabetes self-management recommendations to participants based on their responses to a self-administered questionnaire.


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

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


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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00182026


Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Hertzel C Gerstein, MD MSc FRCPC McMaster University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hertzel Gerstein, Professor, McMaster University
ClinicalTrials.gov Identifier: NCT00182026     History of Changes
Other Study ID Numbers: MCT-68786
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: October 8, 2010
Last Verified: February 2009

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases