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A randomised trial of the cost-effectiveness of a program of screening and intensive multifactorial intervention for type two diabetes in primary care
ISRCTN ISRCTN86769081
DOI 10.1186/ISRCTN86769081
ClinicalTrials.gov identifier NCT00237549
EudraCT number
Public title A randomised trial of the cost-effectiveness of a program of screening and intensive multifactorial intervention for type two diabetes in primary care
Scientific title
Acronym The ADDITION Study
Serial number at source 061895
Study hypothesis 1. To evaluate the effectiveness and cost (economic and psychological) of a program of screening and intensive multifactorial intervention for type two diabetes in primary care.
2. To measure the effect of a multifactorial intervention for people with screen-detected type two diabetes aged 40 to 69 years on modelled mortality and cardiovascular risk.
3. To assess the psychological and health service costs of screening for type two diabetes.
4. To provide the National Screening Committee with timely evidence to inform the decision on whether screening for type two diabetes should become part of health policy in the United Kingdom.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Pragmatic randomised parallel group design
Countries of recruitment Denmark, Netherlands, United Kingdom
Disease/condition/study domain Type two diabetes
Participants - inclusion criteria 1. Aged 40 to 69 years
2. Without known diabetes but with a diabetes risk score in the top 30%
Participants - exclusion criteria 1. Already have diabetes
2. Are pregnant or lactating
3. Have a psychotic illness
4. Have an illness with a prognosis of less than one year
Anticipated start date 01/06/2001
Anticipated end date 31/12/2010
Status of trial Completed
Patient information material
Target number of participants Recruitment completed on 31st March 2006
Interventions In a pragmatic, parallel group design, general practices recruited to the study in the local area are randomly allocated centrally to control, to screening for type two diabetes followed by routine care of screen-detected cases according to national recommendations, and to screening followed by intensive multifactorial intervention. A minimisation procedure is used to balance the baseline practice variables.
Primary outcome measure(s) Risk models for mortality and cardiovascular events, specific to people with diabetes, based on age, gender, blood pressure, Body Mass Index (BMI), smoking, previous myocardial infarction, total cholesterol, triglyceride, High Density Lipoprotein (HDL), HbA1c and albuminuria.
Secondary outcome measure(s) No secondary outcome measures
Sources of funding The Wellcome Trust (UK) (grant ref: 061895)
Trial website http://www.addition.au.dk/
Publications 1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19435491
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23040422
Contact name Dr  Simon  Griffin
  Address MRC Epidemiology Unit
Strangeways Research Laboratory
Worts Causeway
  City/town Cambridge
  Zip/Postcode CB1 8RN
  Country United Kingdom
  Tel +44 (0)1223 330315
  Fax +44 (0)1223 740050
  Email simon.griffin@mrc-epid.cam.ac.uk
Sponsor CamStrad (Cambridgeshire Support Team - Research and Development) (UK)
  Address Nightingale Court
Ida Darwin
  City/town Cambridge
  Zip/Postcode CB1 5EE
  Country United Kingdom
  Tel +44 (0)1223 884182
  Email steve.young@cambcity-pct.nhs.uk
  Sponsor website: http://www.camstrad.nhs.uk
Date applied 15/12/2006
Last edited 03/12/2012
Date ISRCTN assigned 15/12/2006
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