Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499824
Status:
COMPLETED
Last Update Posted:
2010-05-04
First Post:
2007-07-09
Brief Title:
GIANT General Practitioner Implementation in Asia of Normoglycaemic Targets
Sponsor:
International Diabetes Institute Australia
Organization:
International Diabetes Institute Australia
Study Overview
Official Title:
GIANT General Practitioner Implementation in Asia of Normoglycaemic Targets
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GIANT
Brief Summary:
To test whether the International Diabetes Federation - Western Pacific Region IDF-WPR Guidelines are more effective than standard practices in primary care general practitioner clinics for the management of type 2 diabetes mellitus T2DM in Asia A 12-month multinational multicentre prospective cluster randomisation clinical trial within a primary care setting with 2 parallel treatment arms diabetes management using IDF-WPR guidelines versus standard clinic practices 400 subjects will be recruited from 100 sites 4 subjects per site in ten Asian countries China Hong Kong Indonesia Korea Malaysia Philippines Singapore Taiwan Thailand and Vietnam
Detailed Description:
Description of interventions exposure and control treatment This is a prospective multinational multicentre cluster-randomised study conducted within the primary care setting with two parallel treatment arms standard clinical practice versus education on diabetes management using International Diabetes Federation - Western Pacific Region IDF-WPR Type 2 diabetes practical targets and treatments The study duration will be 12 months
100 General Practitioners GPs 10 per country will be randomised to receive education on the IDF-WPR guidelines or to receive no trial-related education
GPs in both groups will be required to recruit 4 of their own patients meeting the eligibility criteria The complete entry criteria are detailed in a following section
GPs in both groups will manage the recruited patients according to their own clinical judgement Frequency of patient visits to the GPs clinic will be determined by the GP All medication prescribed by the GPs should already be registered in the participating countries
Blood sampling of patients will be required at Study Visit 1 ScreeningBaseline Study Visit 2 month 6 and Study Visit 3 month 12
The intervention will comprise an educational program on the guidelines for GPs and will be carried out by the national coordinating centre in each country based on a template provided by the international coordinating centre International Diabetes Institute Australia The educational program for the GPs randomised to the intervention arm will
1 Combine didactic and interactive sessions
2 Involve opinion leaders ie the national lead investigator
3 Aim to resolve barriers to practical implementation of guidelines already identified from previous studies eg discuss starting insulin
4 Present the evidence for the guidelines
5 Highlight any conflicts between the guidelines and local prescribing regulations and confirm the need to follow the local prescribing regulations in these instances
6 Involve an initial educational symposium and a follow-up continuing medical education symposium at 3 months
Organisational changes to improve guideline adherence for the study will include
1 Paper or electronic reminders of the guidelines will be sent to GPs every 3 months
2 Desktop reminders cards with key guideline algorithms
3 Insertion of a flowsheet diabetes action plan into the patients medical notes by the study nurse at the time of review of the practitioners baseline HbA1c utilisation
Patient-centred approaches to improve guideline adherence for the study will include
1 Encouragement and empowerment of patients to ask questions of the treating practitioners
2 Provision of each patient with a diabetes passport to be held by the patient to encourage discussion between the patient and practitioner and also recording of results of medical examinations This will be provided at the baseline visit to the national coordinating centre
100 General Practitioners GPs 10 per country will be randomised to receive education on the IDF-WPR guidelines or to receive no trial-related education
GPs in both groups will be required to recruit 4 of their own patients meeting the eligibility criteria The complete entry criteria are detailed in a following section
GPs in both groups will manage the recruited patients according to their own clinical judgement Frequency of patient visits to the GPs clinic will be determined by the GP All medication prescribed by the GPs should already be registered in the participating countries
Blood sampling of patients will be required at Study Visit 1 ScreeningBaseline Study Visit 2 month 6 and Study Visit 3 month 12
The intervention will comprise an educational program on the guidelines for GPs and will be carried out by the national coordinating centre in each country based on a template provided by the international coordinating centre International Diabetes Institute Australia The educational program for the GPs randomised to the intervention arm will
1 Combine didactic and interactive sessions
2 Involve opinion leaders ie the national lead investigator
3 Aim to resolve barriers to practical implementation of guidelines already identified from previous studies eg discuss starting insulin
4 Present the evidence for the guidelines
5 Highlight any conflicts between the guidelines and local prescribing regulations and confirm the need to follow the local prescribing regulations in these instances
6 Involve an initial educational symposium and a follow-up continuing medical education symposium at 3 months
Organisational changes to improve guideline adherence for the study will include
1 Paper or electronic reminders of the guidelines will be sent to GPs every 3 months
2 Desktop reminders cards with key guideline algorithms
3 Insertion of a flowsheet diabetes action plan into the patients medical notes by the study nurse at the time of review of the practitioners baseline HbA1c utilisation
Patient-centred approaches to improve guideline adherence for the study will include
1 Encouragement and empowerment of patients to ask questions of the treating practitioners
2 Provision of each patient with a diabetes passport to be held by the patient to encourage discussion between the patient and practitioner and also recording of results of medical examinations This will be provided at the baseline visit to the national coordinating centre
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None