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ISRCTN
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ISRCTN17844016
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ClinicalTrials.gov identifier
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Public title
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DESMOND (Diabetes Education and Self Management for Ongoing and Newly Diagnosed): a randomised controlled trial of a structured group education programme for people newly diagnosed with type two diabetes
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Scientific title
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Acronym
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DESMOND
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Serial number at source
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N/A
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Study hypothesis
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To evaluate the effectiveness and feasibility of delivering structured group self-management education to individuals newly diagnosed with type two diabetes.
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Ethics approval
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Approval received from Multi-centre Research Ethics Committee (MREC) on the 16th June 2004.
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Study design
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Cluster 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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Self management of type two diabetes
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Participants - inclusion criteria
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1. Greater than 18 years of age
2. Referred to the study within four weeks of diagnosis of type two diabetes
3. In intervention group, able to attend the intervention within 12 weeks of diagnosis
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Participants - exclusion criteria
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1. Are unable to give informed consent
2. Have been recruited to take part, or are already taking part in other research
3. Have severe and enduring mental health problems
4. Are not primarily responsible for their own care
5. Are unable to participate in a group programme
6. Have insufficient understanding of English to participate in the group education
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Anticipated start date
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01/07/2004
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Anticipated end date
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31/01/2007
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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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1,000
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Interventions
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A programme of six hours of structured group education consisting of two three-hour sessions offered as either one day or two half-days, facilitated by two health care professionals trained to deliver the intervention to groups of up to ten people newly diagnosed with type two diabetes, who may be accompanied by a partner, family member or friend.
This is compared to a control group receiving enhanced routine care.
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Primary outcome measure(s)
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Glycaemic control as measured by HbA1c at 12 months.
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Secondary outcome measure(s)
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1. Cardiovascular (CV) risk as measured by lipid profile and blood pressure
2. Quality of life indicators, diabetes control, self-care and illness belief perceptions of patients at 12 months
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Sources of funding
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1. Diabetes UK (UK) (ref: BDA:RD04/0002922)
2. Department of Health (UK)
3. NovoNordisk (UK) - unrestricted educational grant
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18276664
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Contact name
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Prof
Melanie
Davies
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Address
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Diabetes Research Team
Level 1 Victoria Building
Leicester Royal Infirmary
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City/town
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Leicester
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Zip/Postcode
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LE1 5WW
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Country
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United Kingdom
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Sponsor
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University Hospitals of Leicester NHS Trust (UK)
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Address
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Gwendolen House
Gwendolen Road
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City/town
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Leicester
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Zip/Postcode
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LE5 4PW
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Country
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United Kingdom
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Sponsor website:
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http://www.uhl-tr.nhs.uk/
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Date applied
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19/04/2007
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Last edited
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18/02/2008
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Date ISRCTN assigned
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16/05/2007
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