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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00182026
Enrollment
500
Registered
2005-09-16
Start date
2005-06-30
Completion date
2009-12-31
Last updated
2010-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes, community intervention, self-management, prevention

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.

Interventions

BEHAVIORALpersonal 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.

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
A1c6 months and 1 year

Secondary

MeasureTime frame
diabetes-specific quality of life1 year
diabetes-related self-care behaviours, drug use, clinical outcomes6 months and 1 year
incremental cost/quality-adjusted life-year [QALY]6 months and 1 year

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026