GIANT: General Practitioner Implementation in Asia of Normoglycaemic Targets — GIANT  

Type 2 Diabetes Mellitus Clinical Trial

Official title: GIANT: General Practitioner Implementation in Asia of Normoglycaemic Targets

Status Completed

Clinical Trial 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).

Clinical Trial Description

Description of intervention(s) / 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 GP's 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 (Screening/Baseline), 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, i.e. the national lead investigator

3. Aim to resolve barriers to practical implementation of guidelines already identified from previous studies (e.g. 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 patient's medical notes by the study nurse (at the time of review of the practitioner's 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT00499824
• Study type: Interventional
• Source: International Diabetes Institute, Australia
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Completion date: February 2009