Diabetes Intervention in the community to help achieve reduced glucose elevation: Diabetes IN-CHARGE

ISRCTN ISRCTN45031143
DOI https://doi.org/10.1186/ISRCTN45031143
ClinicalTrials.gov number NCT00182026
Secondary identifying numbers MCT-68786
Submission date
10/08/2005
Registration date
10/08/2005
Last edited
15/02/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Hertzel C Gerstein
Scientific

McMaster University
1200 Main Street West
Room 3V38
Hamilton, Ontario
L8N 3Z5
Canada

Phone +1 905 521 2100 ext. 73371
Email gerstein@mcmaster.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised trial of diabetes intervention in the community to help achieve reduced glucose elevation: Diabetes IN-CHARGE
Study acronymDiabetes IN-CHARGE
Study objectivesThis 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(s)McMaster University Research Ethics Board gave approval on the 31st August 2004.
Health condition(s) or problem(s) studiedType 2 diabetes
InterventionParticipants 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 typeOther
Primary outcome measureHbA1c Levels
Secondary outcome measures1. 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 study start date01/04/2005
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants500
Key inclusion criteria500 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%
Key exclusion criteria1. 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
Date of first enrolment01/04/2005
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Canada

Study participating centre

McMaster University
Hamilton, Ontario
L8N 3Z5
Canada

Sponsor information

McMaster University Health Sciences Centre (Canada)
University/education

1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada

Website http://fhs.mcmaster.ca/main/index.html
ROR logo "ROR" https://ror.org/02fa3aq29

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-68786)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2011 Yes No

Editorial Notes

15/02/2019: Publication reference added.