Name:

ADDITION Cambridge

Parent study:

Addition, Anglo Danish Dutch study of Intensive Treatment In People with screen detected diabetes in primary care

Other names:

N/A

Description:

ADDITION is the Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care.

ADDITION-Europe is a basic data set containing information at baseline and 5-year follow-up from all four European centres: Cambridge, Leicester, Denmark and the Netherlands. We also hold more extensive data sets for Cambridge; see the ADDITION-Cambridge, ADDITION-Plus, ADDITION-Cambridge-screening and ADDITION-10% pages.

The database follows the Unit's generic model and standardises its structure and management to match other studies for data sharing.

Abstract:

The multi-centre Anglo-Danish-Dutch Study of Intensive Treatment In People with Screen Detected Diabetes in Primary Care (ADDITION-Europe) was established in 2001. It consists of a screening phase, and (ii) a pragmatic, cluster-randomised parallel group trial of intensive multifactorial treatment versus routine care in four centres (Denmark, Cambridge UK, the Netherlands and Leicester UK). Following screening in 343 practices, 3,057 eligible participants with screen-detected diabetes agreed to take part in the treatment trial. Participants were followed-up after five years to examine CVD events (99.9% endpoint ascertainment), microvascular outcomes and health status in the two groups.

Locations:

Cambridge Test Centre The Centre

Keywords:

Type 2 diabetes, screening, cardiovascular disease, randomised trial, intensive treatment, primary care

Research areas:

Screening for undiagnosed diabetes patients, and early treatment of newly-diagnosed diabetes patients.

Research purposes:

The study aimed to examine the effects of intensive treatment (IT) vs routine care (RC) on patient-reported outcomes after 5 years in screen-detected diabetes patients.

Population:

People aged 40-69 years without known diabetes.

Status:

Data collection and cleaning is finished for baseline, one-year and five-year datasets. Ten-year follow-up is planned for 2014-15. Data cleaning has been carried out by ADDITION Cambridge staff.

Recruitment:

No longer recruiting.

Between April 2001 and December 2006, 3,057 people with screen-detected diabetes were recruited to the study (mean age 59.7 years, 58% men) after a stepwise screening programme involving 76,308 people screened in 334 general practices in three countries.

Start date:

Recruitment start: April 2001

End date:

Recruitment end: December 2006

Links:

Title	Five-year trial results
Publication	http://www.sciencedirect.com/science/article/pii/S0140673611606983
Website	http://addition.au.dk/
PubMed	http://www.ncbi.nlm.nih.gov/pubmed/21705063

Identifiers:

Identifier	Description
NCT00237549	at ClinicalTrials.gov

Approvals required:

Approval	Details
Ethics	867 individuals agreed to participate and all respondents provided written informed consent. Ethics approval was granted by the Eastern Multi-Regional Ethics Committee (ref 02/5/54). The study was conducted in accordance with the principles of the 1996 Helsinki Declaration.

Funding required:

Funding	Details
Cambridge	ADDITION-Cambridge was supported by the Wellcome Trust, the Medical Research Council, the NIHR Health Technology Assessment Programme, National Health Service R&D support funding and the National Institute for Health Research. SJG received support from the Department of Health NIHR grant funding scheme.

Data access:

Data requests are submitted to the ADDITION-Cambridge trial steering committee (TSC) for approval. A Data Request Form for submission to the ADDITION-Cambridge TSC is available and once completed should be sent in the first instance to datasharing@mrc-epid.cam.ac.uk (or alternatively please print, complete, scan and submit using this PDF). The ADDITION-Cambridge data analyst, Dr Clare Boothby, will manage the processing of your data request.

Data collected:

Anthropometry, biochemistry (blood and urine), self-report demographics, self-report medical history (inc. Rose angina questionnaire), self-report health service use, self-report medication use, self-report alcohol intake, self-report smoking, self-report neuropathy (Michigan questionnaire), self-report physical activity (IPAQ questionnaire, EPAQ questionnaire), self-report anxiety, self-report health state (EuroQoL questionnaire, SF-36 questionnaire, ADDQoL questionnaire, WBQ12 questionnaire), self-report diabetes treatment satisfaction, self-report diet (EPIC FFQ questionnaire), retinopathy, ECGs, cardiovascular events, deaths, self-report treatment satisfaction, self-report diabetes knowledge.

Sample size:

867 individuals with screen-detected diabetes.

Sampling method:

The invitation list for screening was defined at the outset of the study; practices were asked to only invite the patients on the list that we provided. In the screening group (IT and RC), eligible individuals were sent a personal invitation from their general practitioner to attend their practice for stepwise screening including random capillary blood glucose and HbA1c tests, a fasting capillary blood glucose test, followed by a confirmatory oral glucose tolerance test (OGTT) undertaken in a local outpatient facility. Individuals attending the final OGTT stage also underwent assessment of cardiovascular risk factors including measurement of body mass index, waist circumference, blood pressure and blood lipids. Diagnosis of diabetes was based on the 1999 World Health Organisation criteria. Screening took place between January 2002 and March 2006.

Participation type:

Opt in

Inclusion criteria:

Individuals were eligible to be invited for screening if they were registered with one of the participating general practices, aged 40-69 years, not known to have diabetes and with a diabetes risk score of >0.17 (corresponding to the top 25% of the population distribution.

Exclusion criteria:

General practitioners assessed patients against exclusion criteria: an illness with a life expectancy of less than twelve months, housebound, pregnancy or lactation, or psychological or psychiatric problems that might invalidate informed consent.

Current size:

867 participants

Data collection events:

Name	Description	Collection type	Categories
Baseline clinic	Baseline anthropometry, biochemistry, questionnaires	Clinic measurement
One year clinic	One year anthropometry, biochemistry, retinopathy, ECGs, questionnaires
5 year clinical	5 year anthropometry, biochemistry, retinopathy, ECGs, questionnaires	Clinical measurement
5 year CVD events	5 year vital status and CVD event history	Medical record / database search

Accountable people:

Role	Name (follow link for contact details)
Chief Investigator	Prof Simon Griffin
Data Analyst	Dr Clare Boothby

Data sources:

• Access overview study details by following the OVERVIEW link for a study
• Access the details of a studies data and releases by following the RELEASE link for a study
• Access the latest study data dictionary by following the DICTIONARY link for a study
• Access the study questionaiires by following the QUESTIONNAIRES link for a study

OVERVIEW

RELEASE

DICTIONARY

QUESTIONNAIRES

Related parties:

N/A

Additional information:

N/A

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