The ADDITION Study. Intensive Treatment in People With Screen Detected Diabetes in Primary Care. (ADDTION)
|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: NCT00237549|
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : December 20, 2013
The ADDITION study comprise 2 parts: screening for Type 2 diabetes and intensive treatment compared to standard treatment.
- In the screening study, the feasibility and results of country specific models to identify undiagnosed individuals with Type 2 diabetes will be evaluated.
- In the treatment study the effects of routine care in general practice according to local and national guidelines will be compared with an intensive ADDITION protocol, including structured lifestyle education (dietary modification, increased physical activity and smoking cessation) and intensive treatment of blood glucose, blood pressure and lipids, and prophylactic aspirin with or without motivational interviewing, on mortality, macrovascular and microvascular disease. Furthermore the impact of treatment on health status, treatment satisfaction and health service costs will also be assessed.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Procedure: optimised treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3057 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The ADDITION Study. Anglo-Danish-Dutch Study of Intensive Treatment In PeOple With screeN Detected Diabetes in Primary Care|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
The 334 general practices in Denmark, United Kingdom and the Netherlands have been randomised to screening for diabetes followed by routine care (RC group) according to national guidelines, or screening followed by multifactorial treatment (IT group).
Procedure: optimised treatment
The intervention targeted individual patients and the Primary Care Team. Practitioners were trained in a target driven, intensive multifactorial approach including lifestyle advice (smoking cessation, physical activity 30 min./day and healthy diet) and pharmacological treatment with the aim of reducing the complications of diabetes as described in protocol.
The training included meetings, practice visiting, written feed back reports and reminders on controls.
- Cardiovascular mortality [ Time Frame: Sept 2010 ]
- MI (non fatal) [ Time Frame: Sept 2010 ]
- Stroke (non fatal) [ Time Frame: Sept 2010 ]
- Revascularisation (operating procedures) [ Time Frame: Sept 2010 ]
- Amputations, non traumatic [ Time Frame: Sept 2010 ]
- All cause mortality [ Time Frame: 2010 ]
- Development of renal impairment [ Time Frame: 2010 ]
- Progression of retinopathy [ Time Frame: 2010 ]
- Health economy, patient and health service costs and gains [ Time Frame: 2010 ]
- Perceived health, SF36, AddQol [ Time Frame: 2010 ]
- Neuropathy, periphery and autonomy [ Time Frame: 2011 ]
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): NCT00237549
|Institute of Public Health|
|Aarhus, Denmark, 8000|
|Julius Centre for health Sciences and Primary Care, University of Utrecht|
|Department of Public Health and general Practice|
|Cambridge, United Kingdom, UK CB2 2SR|
|University Hospital and Department of Health Sciences, University of Leicster|
|Leicester, United Kingdom|
|Study Chair:||Torsten Lauritzen, Professor||Institutute of Public Health, Dep. of General practice, Aarhus University, Denmark|