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

McMaster University

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: personal feedback report

Study type: Interventional

Funder types: Other

Identifiers

NCT00182026

MCT-68786

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)