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
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Jun 2005
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedOctober 8, 2010
February 1, 2009
4.5 years
September 9, 2005
October 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A1c
6 months and 1 year
Secondary Outcomes (3)
diabetes-related self-care behaviours, drug use, clinical outcomes
6 months and 1 year
diabetes-specific quality of life
1 year
incremental cost/quality-adjusted life-year [QALY]
6 months and 1 year
Interventions
A computer-generated feedback report that provides personalized diabetes self-management recommendations to participants based on their responses to a self-administered questionnaire.
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McMaster Universitylead
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (1)
McMaster University
Hamilton, Ontario, L8N 3Z5, Canada
Related Publications (1)
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.
PMID: 21680723DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hertzel C Gerstein, MD MSc FRCPC
McMaster University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 16, 2005
Study Start
June 1, 2005
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
October 8, 2010
Record last verified: 2009-02