Clinical trial NCT00182026: Diabetes IN-CHARGE: Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation
Official title: A Randomized Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation: Diabetes IN-CHARGE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
community intervention
self-management
prevention
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-16
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: A1c
timeFrame: 6 months and 1 year
Secondary outcomes:
measure: diabetes-related self-care behaviours, drug use, clinical outcomes
timeFrame: 6 months and 1 year
measure: diabetes-specific quality of life
timeFrame: 1 year
measure: incremental cost/quality-adjusted life-year [QALY]
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Hertzel C Gerstein, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.