|
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
|
