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ISRCTN
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ISRCTN99350009
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ClinicalTrials.gov identifier
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Public title
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Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND) Lay Educator Study
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Scientific title
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Testing a newly-developed training programme for lay educators delivering the Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND) programme
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Acronym
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N/A
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Serial number at source
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1
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Study hypothesis
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The main aim of the study is to test the hypothesis that joint teams of lay educators and health care professionals can deliver structured education in diabetes with the same degree of interaction fidelity, quality and efficacy as health care professional teams. Equivalence of outcomes for patients who have attended sessions delivered by the two categories of team will be used as a proxy for equivalence in terms of delivery of effective education.
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Ethics approval
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Leicestershire, Northamptonshire and Rutland Research Ethics Committee 1 approved on the 19th August 2009 (ref: 09/H0406/87)
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Study design
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Open label parallel 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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1. Over the age of 18 years, either sex
2. Newly diagnosed with type 2 diabetes
3. Can participate in the education programme preferably within 6 months of diagnosis
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Participants - exclusion criteria
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1. Type 1 diabetes
2. Taking insulin
3. Unable to give informed consent
4. Severe and enduring mental health problems (i.e. under the care of the specialist mental health team)
5. Unable to take part in a group programme
6. Not primarily responsible for their own care
7. Unable to participate in groups conducted in English (only for the non-BME sites)
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Anticipated start date
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08/01/2010
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Anticipated end date
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01/09/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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256
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Interventions
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GP/practice nurse will inform patients about the study and if interested hands them a study recruitment pack, which contains the Patient Information leaflet. The referral form is completed and sent to the local coordinator informing them patients interested. The co-ordinator contacts the patient by phone within a week, but not less than 24 hours after referral.
Patients who indicate their wish to join the study will be offered the first available study course. If the first course is judged unsuitable, they will be offered the next available study course. Once patients have been booked onto a study course they will be sent an appointment letter with a questionnaire booklet. When patients attend the course their consent will be taken by the health care professional educators before the start of the study course. The study courses will be delivered either as one full day or two half days.
This will be a one-off course that they will attend as part of the study and 4 months after attending the course patients will be sent a reminder letter, along with a questionnaire booklet, to have their data collected at their practice. GPs will be informed via a letter if their patients are taking part or not.
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Primary outcome measure(s)
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Change in coherence score. This is an illness belief score which provides a measure of an individual’s understanding of their diabetes and is determined using a validated tool, the Diabetes Illness Perceptions Questionnaire (IPQ-R).
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Secondary outcome measure(s)
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Based on changes between baseline and four months:
1. Change in personal responsibility score (obtained using the IPQ-R self-report questionnaire)
2. Change in depression score (obtained using the Hospital Anxiety and Depression Scale [HADS-D] self-report questionnaire)
3. Changes in biomedical and anthropometric measures
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Sources of funding
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Diabetes UK (UK)
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Trial website
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Publications
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Contact name
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Dr
Marian
Carey
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Address
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DESMOND Project Office
Ward 38
Level 6 Windsor Building
Leicester Royal Infirmary
Infirmary Square
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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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Email
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marian.carey@uhl-tr.nhs.uk
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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 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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Email
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carolyn.maloney@uhl-tr.nhs.uk
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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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22/12/2009
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Last edited
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01/02/2010
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Date ISRCTN assigned
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01/02/2010
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