Diabetes IN-CHARGE: Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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|
- A1c [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||June 2005|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Behavioral: personal feedback report
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:
- diabetes is now a major public health problem; and
- 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:
- provides information;
- generates and communicates specific evidence-based recommendations to users from a self-administered questionnaire;
- copies this communication to the patient's designated physician;
- facilitates access to community resources; and
- 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.
|Hamilton, Ontario, Canada, L8N 3Z5|
|Principal Investigator:||Hertzel C Gerstein, MD MSc FRCPC||McMaster University|