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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
personal feedback report
Sponsored by
McMaster University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring diabetes, community intervention, self-management, prevention

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • McMaster University

Outcomes

Primary Outcome Measures

A1c

Secondary Outcome Measures

diabetes-related self-care behaviours, drug use, clinical outcomes
diabetes-specific quality of life
incremental cost/quality-adjusted life-year [QALY]

Full Information

First Posted
September 9, 2005
Last Updated
October 7, 2010
Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00182026
Brief Title
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

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
diabetes, community intervention, self-management, prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
personal feedback report
Intervention Description
A computer-generated feedback report that provides personalized diabetes self-management recommendations to participants based on their responses to a self-administered questionnaire.
Primary Outcome Measure Information:
Title
A1c
Time Frame
6 months and 1 year
Secondary Outcome Measure Information:
Title
diabetes-related self-care behaviours, drug use, clinical outcomes
Time Frame
6 months and 1 year
Title
diabetes-specific quality of life
Time Frame
1 year
Title
incremental cost/quality-adjusted life-year [QALY]
Time Frame
6 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hertzel C Gerstein, MD MSc FRCPC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21680723
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.
Results Reference
derived

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

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