Diabetes IN-CHARGE: Trial of Diabetes Intervention in t...

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

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

This study is currently recruiting participants.
Verified by McMaster University, November 2007
Sponsors and Collaborators: Hamilton Health Sciences
Canadian Institutes of Health Research (CIHR)

Information provided by: McMaster University
ClinicalTrials.gov Identifier: NCT00182026

Purpose
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.

Condition Intervention
Diabetes Mellitus, Type 2
Behavioral: personal feedback report

MedlinePlus related topics: Diabetes
Drug Information available for: Dextrose
U.S. FDA Resources
Study Type:Interventional
Study Design:Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:A Randomized Trial of Diabetes Intervention in the Community to Help Achieve Reduced Glucose Elevation: Diabetes IN-CHARGE

Further study details as provided by McMaster University:

Primary Outcome Measures:
A1c [ Time Frame: 6 months and 1 year ]

Secondary Outcome Measures:
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 ]

Estimated Enrollment:500
Study Start Date:June 2005
Estimated Study Completion Date:December 2008

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:

diabetes is now a major public health problem; and
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:

provides information;
generates and communicates specific evidence-based recommendations to users from a self-administered questionnaire;
copies this communication to the patient's designated physician;
facilitates access to community resources; and
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
Ages Eligible for Study:40 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Yes
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
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182026

Contacts
Contact: Janet L Greb, MPA(HSA) 905-525-9140 ext 22359 grebj@mcmaster.ca

Locations
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Janet L Greb, MPA(HSA) 905-525-9140 ext 22359 grebj@mcmaster.ca
Principal Investigator: Hertzel C Gerstein, MD, MSc
Sub-Investigator: Dereck L Hunt, MD, MSc
Sub-Investigator: Robert B Haynes, MD, MSc, PhD
Sub-Investigator: William L Harper, BSc, MD
Sub-Investigator: Sarah E Capes, MD, MSc
Sub-Investigator: Ron A Goeree, BA, MA
Sub-Investigator: Anne M Holbrook, PhrmD MD MSc
Sub-Investigator: Gina Agarwal, MBBS, MSc

Sponsors and Collaborators
Hamilton Health Sciences
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Hertzel C Gerstein, MD MSc FRCPC McMaster University

Study ID Numbers:MCT-68786
First Received:September 9, 2005
Last Updated:November 8, 2007
ClinicalTrials.gov Identifier:NCT00182026 [history]
Health Authority:Canada: Health Canada

Keywords provided by McMaster University:
diabetes
community intervention
self-management
prevention

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders