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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00182026
• Other study ID #: MCT-68786
• Status: Active, not recruiting
• Phase: N/A
• First received: September 9, 2005
• Last updated: October 7, 2010
• Start date: June 2005
• Est. completion date: December 2009

Study information

• Verified date: February 2009
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1c		6 months and 1 year	No
Secondary	diabetes-related self-care behaviours, drug use, clinical outcomes		6 months and 1 year	No
Secondary	diabetes-specific quality of life		1 year	No
Secondary	incremental cost/quality-adjusted life-year [QALY]		6 months and 1 year	No