Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatment personal feedback report
Sponsor McMaster University
Collaborator Canadian Institutes of Health Research (CIHR)
Start date June 2005
End date December 2009
Trial size 500 participants
Trial identifier NCT00182026, MCT-68786

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
A1c
time frame: 6 months and 1 year

Secondary Outcomes

Measure
diabetes-related self-care behaviours, drug use, clinical outcomes
time frame: 6 months and 1 year
diabetes-specific quality of life
time frame: 1 year
incremental cost/quality-adjusted life-year [QALY]
time frame: 6 months and 1 year

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title A Randomized Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation: Diabetes IN-CHARGE
Principal investigator Hertzel C Gerstein, MD MSc FRCPC
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by McMaster University.