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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: personal feedback report


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1c |  | 6 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diabetes-related self-care behaviours, drug use, clinical outcomes |  | 6 months and 1 year | 
| diabetes-specific quality of life |  | 1 year | 
| incremental cost/quality-adjusted life-year [QALY] |  | 6 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, community intervention, self-management, prevention