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ISRCTN
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ISRCTN99175498
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DOI
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10.1186/ISRCTN99175498
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Does adding facilitated behaviour change improve outcomes for people with recently diagnosed diabetes?
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Scientific title
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Acronym
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The AdditionPlus study
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Serial number at source
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G0001164
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Study hypothesis
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1. Can an approach, based on theory and evidence from psychology, to increase and maintain health-promoting behaviours (physical activity, dietary change, taking medication and smoking cessation) achieve clinically important and measurable change in these behaviours when offered to people with screen-detected diabetes?
2. What is the effect on modelled cardiovascular risk and the cost (economic and psychological) of a behavioural intervention for people aged 40 to 69 years with screen-detected diabetes?
3. What are the added benefits and costs of facilitation of healthy behaviours among people aged 40 to 69 years with diabetes detected by screening and intensively treated?
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Single-blind multipractice randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Diabetes
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Participants - inclusion criteria
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Patients aged 40-69 with a diabetes risk score more than or equal to 0.17 (representing the top 25% of risk distribution) are invited for a random capillary screening test for diabetes. Patients are eligible to take part if the diagnosis of diabetes is confirmed by subsequent fasting capillary test and oral glucose tolerance test.
Following the funded extension inclusion criteria extended to include patients aged 40 to 69 years with type two diabetes diagnosed within the last three years.
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Participants - exclusion criteria
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Potential participants are excluded if they are pregnant or lactating, have a psychotic illness or have an illness with a likely prognosis of less than one year.
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Anticipated start date
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01/11/2001
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Anticipated end date
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30/04/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1000 for risk factor calculation; 400 for behaviour intervention
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Interventions
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Recruited practices have been randomised to screening for diabetes followed by Routine Care (RC) according to national guidelines or screening followed by Intensive multifactorial intervention (I). We hope to achieve this intensive treatment through the addition of the following features to the existing diabetes care within the practice:
1. Additional NHS R&D Support for Science funding to facilitate more frequent contact between patients and practitioners and to facilitate dietician referrals for all newly diagnosed patients
2. Three practice-based education sessions with the local diabetologist. Patient education materials providing a shared framework on the causes, consequences and treatment of diabetes
3. Management algorithms specifying prescription of an angiotensin converting enzyme inhibitor (ACE) and aspirin, followed by stepwise target-led treatment to reduce hyperglycaemia, blood pressure, hyperlipidaemia and microalbuminuria
4. Provision of glucometers for patients and any necessary training in their use for practitioners
Patients in the intervention arm (I) are randomly allocated to receive the additional behavioural intervention (I1) or not (I2). The behavioural intervention is delivered by trained facilitators during six consultations in the surgery and by telephone follow up. It is designed to strengthen both motivation to increase physical activity, adopt a healthier diet, take prescribed medication, stop smoking if relevant and to teach self-management skills to achieve and maintain these changes, using a person centered approach. Following detailed protocols, the facilitator helps patients define achievable goals for behaviour change by exploring the beliefs and attitudes underlying their motivation and confidence to change specific behaviours. Over the first three sessions patients learn how to define specific action plans and to implement these using self-monitoring, reinforcement and relapse prevention techniques. The second three sessions focus on maintaining change by continued use of these skills and their generalisation to other domains, goal setting and review, and motivation-enhancing skills. Over time patients practice these skills in relation to physical activity, dietary intake, taking medication and smoking cessation if relevant. Each session begins with a review of progress, and skills acquired and applied, before moving on to the introduction of new skills on their application to new domains.
Following the funded extension the same intervention is provided to half of the patients with diabetes diagnosed within the last three years, allocated at random.
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Primary outcome measure(s)
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The principal comparisons between I1 and I2 include changes in weight, self-reported physical activity (IPAQ, EPAQ2), diet (Food Frequency Questionnaire), medication adherence (MARS), smoking status and differences at one-year in objectively measured physical activity (PAR, CSA (accelerometer)), diet (plasma vitamin C) and medication adherence (plasma drug levels). A cross domain measure of behaviour change at 1 year is under development. Modelled five year risk of cardiovascular events, incorporating glycaemia, blood pressure and lipid levels represents the main outcome for the trial of intensive treatment (RC vs I). In addition, we propose to assess at all levels along our causal pathway psychological measures (illness perceptions, attitudes and intentions towards targeted healthy behaviours), anthropometric variables (weight, body fat distribution and waist circumference) and biochemical parameters (HbA1c, cholesterol and albumin/creatinine ratio).
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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1. 2007 results in psychological impact of screening in http://www.ncbi.nlm.nih.gov/pubmed/17761995
2. 2007 results on patients' experiences of screening in http://www.ncbi.nlm.nih.gov/pubmed/17762000
3. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18840266
4. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19948642
5. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21463520
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Contact name
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Dr
Simon
Griffin
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Address
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Institute of Public Health
University of Cambridge
University Forvie Site
Robinson Way
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City/town
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Cambridge
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Zip/Postcode
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CB2 2SR
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Country
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United Kingdom
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Sponsor
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Cambridgeshire Support Team (UK)
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Address
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CamSTRAD
Nightingale Court
Ida Darwin
Fulbourn
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City/town
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Cambridge
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Zip/Postcode
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CB21 5EE
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Country
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United Kingdom
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Sponsor website:
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http://www.camstrad.nhs.uk/default.asp?id=
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Date applied
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02/05/2001
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Last edited
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21/07/2011
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Date ISRCTN assigned
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02/05/2001
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