Contact information
Type
Scientific
Primary contact
Dr Hertzel C Gerstein
ORCID ID
Contact details
McMaster University
1200 Main Street West
Room 3V38
Hamilton
Ontario
L8N 3Z5
Canada
+1 905 521 2100 ext. 73371
gerstein@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00182026
Protocol/serial number
MCT-68786
Study information
Scientific title
A randomised trial of diabetes intervention in the community to help achieve reduced glucose elevation: Diabetes IN-CHARGE
Acronym
Diabetes IN-CHARGE
Study hypothesis
This trial will determine if supplementing a community-based diabetes program with an automated system that generates specific evidence-based tailored recommendations to individuals/MDs based on responses to a self-administered questionnaire lowers hemoglobin A1c levels (A1c) more than the community-based program (i.e. Diabetes Hamilton) alone.
As of 15/01/2008, this record was updated to include an extended anticipated end date due to recruitment taking longer than anticipated; the initial end date at the time of registration was 31/07/2007 was updated to 30/06/2009.
As of 26/02/2009 this record was updated to include another extension to the anticipated end date to allow for completion of all follow-ups. The previous end date was 30/06/2009 and this has now been updated to 31/12/2009.
Ethics approval
McMaster University Research Ethics Board gave approval on the 31st August 2004.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type 2 diabetes
Intervention
Participants in the community with type 2 diabetes will be enrolled in Diabetes Hamilton, fill out a questionnaire, and have regular information regarding diabetes management sent to them and their MD. Allocation will be to either receive or not receive automated recommendations and reminders based on the questionnaire response, interpretation of their HbA1c, a customised list of resources, and simple tools to track glucose control, HbA1c and related variables.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
HbA1c Levels
Secondary outcome measures
1. Self-care behaviours
2. Drug use (i.e. angiotensin-converting enzyme [ACE]-inhibitor, cholesterol-lowering
aspirin, angiotensin 2 receptor blocker, beta blocker, diuretic, influenza immunisation)
3. Clinical outcomes
4. Hospitalisations
5. Quality of life
6. Incremental cost per quality-adjusted life-year (QALY)
Overall trial start date
01/04/2005
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
500 participants with type two diabetes, both sex, 30 years and older
1. Type 2 diabetes of 1 or more years duration
2. Ontario Health Insurance Plan (OHIP) coverage
3. Registered in, or willingness to register in Diabetes Hamilton
4. English fluency
5. Provide consent
6. Have home access to either mail, email or the internet
7. Have a baseline HbA1c level greater than 7%
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant exclusion criteria
1. Current pregnancy
2. Institutionalised
3. Cohabiting first degree relative of a participant in the study
4. Inability to read or understand English
5. Inability or unwillingness to consent or comply with the protocol
6. Residence outside the city of Hamilton
Recruitment start date
01/04/2005
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Canada
Trial participating centre
McMaster University
Hamilton, Ontario
L8N 3Z5
Canada
Sponsor information
Organisation
McMaster University Health Sciences Centre (Canada)
Sponsor details
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-68786)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary