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Welcome
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11 February 2012
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| [ Print-friendly version ] |
| DESMOND (Diabetes Education and Self Management for Ongoing and Newly Diagnosed) Foundation Study |
| ISRCTN | ISRCTN25675619 |
| ClinicalTrials.gov identifier | |
| Public title | DESMOND (Diabetes Education and Self Management for Ongoing and Newly Diagnosed) Foundation Study |
| Scientific title | A randomised controlled trial of the DESMOND Foundation Programme for people with established Type 2 diabetes in a multi-ethnic population in Leicester and South Birmingham |
| Acronym | N/A |
| Serial number at source | 1 |
| Study hypothesis | The main aim of the study is to test the hypothesis that a structured education module in diabetes with proven effectiveness in a white, newly diagnosed population can be modified for use in a multi-ethnic population with established diabetes (>=12 months < 10 years duration), to improve biomedical, lifestyle and psychological patient outcomes 6 and 12 months post intervention. |
| Lay summary | |
| Ethics approval | Leicestershire, Northamptonshire & Rutland Research Ethics Committee 1 approved on the 25th February 2010 (ref: 09/H0406/116) |
| Study design | Multi centre cluster randomised controlled trial with randomisation at practice level. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Established Type 2 diabetes mellitus (≥ 12 months < 10 years duration) |
| Participants - inclusion criteria |
1. Patients have established Type 2 diabetes of a duration ≥ 12 months < 10 years duration
2. Not receiving insulin therapy 3. Controlling their diabetes by diet or any combination of OHAs (oral hypoglycaemic agents) 4. HbA1c ≥ 7.0% and ≤ 10.0% 5. Able to participate in a group programme 6. Age ≥ 18 and < 75 years of age 7. South Asian patients whose first language is not English, will need to be Gujarati speaking (Leicester) or Urdu or Punjabi speaking (South Birmingham) |
| Participants - exclusion criteria |
1. Patients who have already attended a DESMOND programme
2. Unable to give informed consent 3. Severe and enduring mental health problems e.g. diagnosed with psychotic illness 4. Patient not primarily responsible for their own care 5. Unable to participate in a group programme (e.g. housebound) 6. Do not have Type 2 diabetes 7. Newly diagnosed with Type 2 diabetes (< 12 months) 8. Currently taking part in a research study 9. Receiving insulin therapy |
| Anticipated start date | 01/07/2010 |
| Anticipated end date | 01/12/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format. Please use contact details below to request a patient information leaflet |
| Target number of participants | 640 |
| Interventions | The DESMOND structured group education programme for patients with established Type 2 diabetes. When delivered in English this a 6 hour programme (two sessions of 3 hours each) or when delivered in Gujarati, Urdu or Punjabi a 12 hour programme (4 sessions of 3 hours each) with an interpreter present. |
| Primary outcome measure(s) | HbA1c measured at 6 and 12 month follow up |
| Secondary outcome measure(s) |
Measures at 6 and 12 month follow up:
1. Blood cholesterol 2. Body weight 3. Blood pressure 4. Waist and hip circumference 5. Lifestyle (smoking and physical activity) 6. Questionnaire tools listed below: 6.1 Illness Perception Questionnaire Revised (IPQ-R) 6.2 Diabetes Illness Representations Questionnaire (DIRQ) 6.3 The Hospital Anxiety & Depression Scale (HADS) 6.4 International Physical Activity Questionnaire (IPAQ) 6.5 Problem Areas in Diabetes Scales (PAIDS) 6.3 International Physical Activity Questionnaire (IPAQ) |
| Sources of funding | National Institute for Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care (CLAHRC) |
| Trial website | |
| Publications | |
| Contact name | Prof Melanie Davies |
| Address |
Diabetes Research
Victoria Building Leicester Royal Infirmary |
| City/town | Leicester |
| Zip/Postcode | LE1 5WW |
| Country | United Kingdom |
| melanie.davies@uhl-tr.nhs.uk | |
| Sponsor | University Hospital of Leicester (UK) |
| Address | Gwendolen Road |
| City/town | Leicester |
| Zip/Postcode | LE5 4PW |
| Country | United Kingdom |
| carolyn.maloney@uhl-tr.nhs.uk | |
| Sponsor website: | http://www.uhl-tr.nhs.uk |
| Date applied | 03/06/2010 |
| Last edited | 29/07/2010 |
| Date ISRCTN assigned | 29/07/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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