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

NCT ID: NCT00182026

Last Updated: 2010-10-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2009-12-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

McMaster University

Principal Investigators

Hertzel C Gerstein, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

References

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. doi: 10.2337/dc11-0006. Epub 2011 Jun 16.

Reference Type: DERIVED

PMID: 21680723 (View on PubMed)

Other Identifiers

MCT-68786

Identifier Type: -

Identifier Source: org_study_id