Name:

ADDITION Plus

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-Plus is a trial nested within the Cambridge arm of the Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care.

ADDITION-Plus is an extensive data set containing information from baseline, one-year and five-year follow-up.

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

Abstract:

ADDITION-Plus is an explanatory randomised controlled trial in 34 general practices in Eastern England. 478 patients with recently diagnosed diabetes were individually randomised to receive (i) intensive treatment (n=239), or (ii) intensive treatment plus a theory-based behaviour change intervention led by a facilitator external to the general practice team (n=239). The aim was to assess whether a theory-based behaviour change intervention delivered by trained and quality-assured lifestyle facilitators can achieve and maintain improvements in physical activity, dietary change, medication adherence and smoking cessation in people with recently diagnosed diabetes. Outcomes were assessed at one and five years.

Locations:

Cambridge, UK The Centre

Keywords:

ADDITION-Plus; diabetes; general practice; health behaviour; randomised trial.

Research areas:

Behaviour change intervention in patients with newly diagnosed diabetes.

Research purposes:

The study aimed to assess whether a theory-based behaviour change intervention delivered by trained and quality-assured lifestyle facilitators can achieve and maintain improvements in physical activity, dietary change, medication adherence and smoking cessation in people with recently diagnosed diabetes.

Population:

478 men and women with recently diagnosed diabetes and a mean age of 60 years.

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-Plus staff.

Recruitment:

No longer recruiting.

Patients were recruited from 34 general practices in the East of England. The majority of practices (n=26) were participating in the intensive treatment arm of the ADDITION-Cambridge trial of treatment of people with diabetes detected by screening. A further eight practices were recruited to increase the participation of recently clinically diagnosed patients. 478 individuals were recruited for ADDITION-Plus.

Start date:

Recruitment start: April 2001

End date:

Recruitment end: December 2006

Links:

Title	Addition Plus trial results
Publication	One year trial paper
Website	Study protocol
PubMed	One year trial paper

Identifiers:

Identifier	Description
ISRCTN99175498	https://www.isrctn.com/ISRCTN99175498

Approvals required:

Approval	Details
Ethics	Ethical approval was obtained from the Eastern Multi-Centre Research Ethics Committee (reference number: 02/5/54). Participants provided written informed consent.

Funding required:

Funding

Details

Addition Plus

The trial is supported by the Medical Research Council (grant reference no: G0001164), the Wellcome Trust (grant reference no: G061895), National Health Service R&D support funding (including the Primary Care Research and Diabetes Research Networks) and National Institute of Health Research under its Programme Grants for Applied Research scheme [RP-PG-0606-1259]. The Primary Care Unit is supported by NIHR Research funds. ATP is supported by the NIHR Biomedical Research Centre at Guy's and St Thomas' NHS Foundation Trust and King's College London. Bio-Rad provided equipment for haemoglobin A1c testing during the screening phase. We are grateful to Diabetes UK for providing patient information materials.

Data access:

Data requests are submitted to the ADDITION-Plus trial steering committee (TSC) for approval, 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-Plus 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, self-report treatment satisfaction, self-report diabetes knowledge, self-report intention to change questionnaire, self-report skills questionnaire, self-report habit questionnaire, objective physical activity, objective smoking status.

Sample size:

478 individuals with recently diagnosed diabetes.

Sampling method:

Patients were recruited from 34 general practices in the East of England. The majority of practices (n=26) were participating in the intensive treatment arm of the ADDITION-Cambridge trial of treatment of people with diabetes detected by screening. A further eight practices were recruited to increase the participation of recently clinically diagnosed patients.

Participation type:

Opt in

Inclusion criteria:

Eligibility criteria were initially assessed by general practice staff and included: age 40-69 years with type 2 diabetes following screening in the ADDITION study or clinical diagnosis during the previous three years.

Exclusion criteria:

Exclusion criteria included anybody who had a psychotic illness or an illness with a likely prognosis of less than one year and women who were pregnant or lactating.

Current size:

478 participants

Data collection events:

Name	Description	Collection type	Categories
Baseline clinic	Baseline anthropometry, biochemistry, questionnaires	Clinic measurement
One year clinic	One year anthropometry, biochemistry, ECGs, questionnaires
5 year clinic	5 year anthropometry, biochemistry, ECGs, questionnaires	Clinic measurement

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