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

Not Applicable

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00182026
• Lead Sponsor: McMaster University

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.

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:

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-16
• Status Verified: 2009-02
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2010-10-07
• Last Update Posted: 2010-10-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
A1c	6 months and 1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada