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
Scientific
McMaster University
1200 Main Street West
Room 3V38
Hamilton, Ontario
L8N 3Z5
Canada
| Phone | +1 905 521 2100 ext. 73371 |
|---|---|
| gerstein@mcmaster.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised trial of diabetes intervention in the community to help achieve reduced glucose elevation: Diabetes IN-CHARGE |
| Study acronym | Diabetes IN-CHARGE |
| Study objectives | 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(s) | McMaster University Research Ethics Board gave approval on the 31st August 2004. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/04/2005 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 500 |
| Key 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% |
| Key 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 |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Canada
Study participating centre
McMaster University
Hamilton, Ontario
L8N 3Z5
Canada
L8N 3Z5
Canada
Sponsor information
McMaster University Health Sciences Centre (Canada)
University/education
University/education
1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada
| Website | http://fhs.mcmaster.ca/main/index.html |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
