Diabetes IN-CHARGE: Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Behavioral: personal feedback report
- A1c [ Time Frame: 6 months and 1 year ]
- 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 ]
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
|Hamilton, Ontario, Canada, L8N 3Z5|
|Principal Investigator:||Hertzel C Gerstein, MD MSc FRCPC||McMaster University|