Addition, Anglo Danish Dutch study of Intensive Treatment In People with screen detected diabetes in primary care
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
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.
ADDITION-Plus; diabetes; general practice; health behaviour; randomised trial.
Behaviour change intervention in patients with newly diagnosed diabetes.
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.
478 men and women with recently diagnosed diabetes and a mean age of 60 years.
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.
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.
Recruitment start: April 2001
Recruitment end: December 2006
|Title||Addition Plus trial results|
|Publication||One year trial paper|
|PubMed||One year trial paper|
|Ethics||Ethical approval was obtained from the Eastern Multi-Centre Research Ethics Committee (reference number: 02/5/54). Participants provided written informed consent.|
|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 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 firstname.lastname@example.org (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.
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.
478 individuals with recently diagnosed diabetes.
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.
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 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.
Data collection events:
|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|
|Role||Name (follow link for contact details)|
|Chief Investigator||Prof Simon Griffin|
|Data Analyst||Dr Clare Boothby|
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