The ADDITION Study. Intensive Treatment in People With Screen Detected Diabetes in Primary Care. (ADDTION)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||The ADDITION Study. Anglo-Danish-Dutch Study of Intensive Treatment In PeOple With screeN Detected Diabetes in Primary Care|
- Cardiovascular mortality [ Time Frame: Sept 2010 ] [ Designated as safety issue: No ]
- MI (non fatal) [ Time Frame: Sept 2010 ] [ Designated as safety issue: No ]
- Stroke (non fatal) [ Time Frame: Sept 2010 ] [ Designated as safety issue: No ]
- Revascularisation (operating procedures) [ Time Frame: Sept 2010 ] [ Designated as safety issue: No ]
- Amputations, non traumatic [ Time Frame: Sept 2010 ] [ Designated as safety issue: No ]
- All cause mortality [ Time Frame: 2010 ] [ Designated as safety issue: No ]
- Development of renal impairment [ Time Frame: 2010 ] [ Designated as safety issue: No ]
- Progression of retinopathy [ Time Frame: 2010 ] [ Designated as safety issue: No ]
- Health economy, patient and health service costs and gains [ Time Frame: 2010 ] [ Designated as safety issue: No ]
- Perceived health, SF36, AddQol [ Time Frame: 2010 ] [ Designated as safety issue: No ]
- Neuropathy, periphery and autonomy [ Time Frame: 2011 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2001|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
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.
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|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|