GIANT: General Practitioner Implementation in Asia of Normoglycaemic Targets (GIANT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00499824|
Recruitment Status : Completed
First Posted : July 11, 2007
Last Update Posted : May 4, 2010
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Behavioral: Education of general practitioners on the IDF-WPR guidelines||Not Applicable|
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:
- Combine didactic and interactive sessions.
- Involve opinion leaders, i.e. the national lead investigator
- Aim to resolve barriers to practical implementation of guidelines already identified from previous studies (e.g. discuss starting insulin)
- Present the evidence for the guidelines.
- Highlight any conflicts between the guidelines and local prescribing regulations, and confirm the need to follow the local prescribing regulations in these instances
- 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:
- Paper or electronic reminders of the guidelines will be sent to GPs every 3 months.
- Desktop reminders cards with key guideline algorithms.
- 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:
- Encouragement and empowerment of patients to ask questions of the treating practitioners
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||386 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||GIANT: General Practitioner Implementation in Asia of Normoglycaemic Targets|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||February 2009|
Medical Practitioners who receive education on diabetes management following the guidelines of the International Diabetes Federation Western Pacific Region
Behavioral: Education of general practitioners on the IDF-WPR guidelines
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). This will involve:
an initial educational symposium and a follow-up continuing medical education symposium at 3 months; paper or electronic reminders of the guidelines sent to GPs every 3 months; desktop reminder cards with guideline algorithms; insertion of a flowsheet (diabetes action plan) into the patient's medical notes by the study nurse; provision of each patient with a "diabetes passport" to be held by the patient.
No Intervention: 2
Medical practitioners who follow standard practice for management of their patients with type 2 diabetes
- Change in HbA1c from baseline in subjects with baseline HbA1c >/=6.5% [ Time Frame: 6 months ]
- HbA1c, FPG, BP, lipids; hypoglycemic events; health care use; number of GP HbA1c measurements; number of treatment escalations; adverse events; barriers to guideline implementation; determine if study patients are representative of GP's diabetic practice [ Time Frame: 6 & 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499824
|China, Hong Kong|
|Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong|
|Shatin, Hong Kong, China|
|Department of Endocrinology & Metabolism, Peking University People's Hospital|
|Beijing, China, 100044|
|Diabetes and Nutrition Center, Dr. Soetomo Teaching Hospital - Airlangga University,|
|Surabaya, Indonesia, 60286|
|Korea, Republic of|
|Department of Endocrinology & Metabolism, Kangnam St. Mary's Hospital, The Catholic University of Medicine|
|Seoul, Korea, Republic of|
|School of Medicine and Health Sciences, Monash University House|
|Johor Bahru, Malaysia, 80100|
|Section of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of the Philippines College of Medicine|
|Diabetes, Lipid and Endocrine Practice, Gleneagles Medical Centre|
|Singapore, Singapore, 258499|
|Dept of Medical Research and Education, Taipei Veterans General Hospital,|
|Diabetes and Endocrinology Unit, Department of Medicine, Rajavithi Hospital,|
|Bangkok, Thailand, 10400|
|National Hospital of Endocrinology,|
|Hanoi, Dongda district, Vietnam|
|Principal Investigator:||Jonathan E Shaw, MD MRCP FRACP||International Diabetes Institute, Australia|