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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by McMaster University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182026
First received: September 9, 2005
Last updated: October 7, 2010
Last verified: February 2009

September 9, 2005
October 7, 2010
June 2005
December 2009   (final data collection date for primary outcome measure)
A1c [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
A1c (6 months & 1 year)
Complete list of historical versions of study NCT00182026 on ClinicalTrials.gov Archive Site
  • diabetes-related self-care behaviours, drug use, clinical outcomes [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
  • diabetes-specific quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • incremental cost/quality-adjusted life-year [QALY] [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
  • - diabetes-related self-care behaviours, drug use, clinical outcomes (6 months & 1 year)
  • - diabetes-specific quality of life (1 year)
  • - incremental cost/QALY (6 months & 1 year)
Not Provided
Not Provided
 
Diabetes IN-CHARGE: Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation
A Randomized Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation: Diabetes IN-CHARGE

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
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.
Not Provided
Sherifali D, Greb JL, Amirthavasar G, Hunt D, Haynes RB, Harper W, Holbrook A, Capes S, Goeree R, O'Reilly D, Pullenayegum E, Gerstein HC. Effect of computer-generated tailored feedback on glycemic control in people with diabetes in the community: a randomized controlled trial. Diabetes Care. 2011 Aug;34(8):1794-8. doi: 10.2337/dc11-0006. Epub 2011 Jun 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
40 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00182026
MCT-68786
No
Hertzel Gerstein, Professor, McMaster University
McMaster University
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Hertzel C Gerstein, MD MSc FRCPC McMaster University
McMaster University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP