Diabetes IN-CHARGE: Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 9, 2005 | ||||
| Last Updated Date | October 7, 2010 | ||||
| Start Date ICMJE | June 2005 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
A1c [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
A1c (6 months & 1 year) | ||||
| Change History | Complete list of historical versions of study NCT00182026 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Diabetes IN-CHARGE: Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation | ||||
| Official Title ICMJE | A Randomized Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation: Diabetes IN-CHARGE | ||||
| 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. |
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| 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:
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:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Diabetes Mellitus, Type 2 | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) | Not Provided | ||||
| Publications * | 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. Epub 2011 Jun 16. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 500 | ||||
| Estimated Completion Date | December 2009 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00182026 | ||||
| Other Study ID Numbers ICMJE | MCT-68786 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Hertzel Gerstein, Professor, McMaster University | ||||
| Study Sponsor ICMJE | McMaster University | ||||
| Collaborators ICMJE | Canadian Institutes of Health Research (CIHR) | ||||
| Investigators ICMJE |
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| Information Provided By | McMaster University | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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