DESMOND (Diabetes Education and Self Management for Ongoing and Newly Diagnosed) Foundation Study
| ISRCTN | ISRCTN25675619 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25675619 |
| Secondary identifying numbers | 1 |
- Submission date
- 03/06/2010
- Registration date
- 29/07/2010
- Last edited
- 08/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Type 2 diabetes is a long-lasting and debilitating disease. It is linked with reduced quality of life and serious complications. The life expectancy of people with type 2 diabetes can be shortened by as much as 10 years. The number of people with type 2 diabetes is growing and it estimated that almost 3.7 million people in the UK have type 2 diabetes. It appears likely that the how much care people take of their health is linked to their long-term wellness. This goes beyond just taking medication or attending their annual review with a doctor (although both are important). Decisions around eating, weight loss strategies, undertaking exercise and stopping smoking all influence how well treatment works. The National Institute for Health and Care Excellence (NICE) advises that structured education should be available to all patients with type 2 diabetes at the time of diagnosis, with annual reinforcement and review also provided. The aims of this study are to assess the effectiveness of a 6-hour group education programme. The study is being run in Leicester and Birmingham to enable a multi-ethnic population to be recruited.
Who can participate?
People who have been diagnosed with type 2 diabetes for 1-9 years who are not taking insulin, but are taking medication for diabetes orally (by mouth).
What does the study involve?
Eligible patients are identified by searches of their GP practice’s database and then are sent an invitation letter and information leaflet. Patients who express an interest are contacted and if they are eligible and interested in taking part they are booked to attend a recruitment clinic. These are staffed by trained research nurses and held in local community venues. Written informed consent is requested and the study measurements are made – blood tests, body weight, blood pressure and waist measurement. The participant is asked to complete a questionnaire which includes questions about their wellbeing, physical activity levels, illness beliefs and quality of life. Participants from practices which have been randomised to the intervention arm are invited to attend the DESMOND Education Programme while participants from practices randomised to the control arm continue with their usual care. 12 months after the study started all participants are invited to a follow-up clinic when the measures made at recruitment are repeated.
What are the possible benefits and risks of participating?
As the study intervention is a group education programme there are unlikely to be any risks to taking part. Patients who attend the programme should benefit by increasing their knowledge about type 2 diabetes. On a larger scale the findings of the research should help in improving the care that is provided to the growing number of people with type 2 diabetes.
Where is the study run from?
Leicester Diabetes Centre
When is the study starting and how long is it expected to run for?
August 2010 to September 2013
Who is funding the study?
National Institute for Health Research (NIHR)
Who is the main contact?
Professor Melanie Davies, melanie.davies@uhl-tr.nhs.uk
Contact information
Scientific
Leicester Diabetes Centre (Broadleaf)
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
| Phone | +44 116 258 6481 |
|---|---|
| melanie.davies@uhl-tr.nhs.uk |
Study information
| Study design | Multi centre cluster randomised controlled trial with randomisation at practice level. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format. Please use contact details below to request a patient information leaflet |
| 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 |
| 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. As of 27/06/2012, the anticipated end date of trial was amended from 01/12/22012 to 30/09/2013. |
| Ethics approval(s) | Leicestershire, Northamptonshire & Rutland Research Ethics Committee 1 approved on the 25th February 2010 (ref: 09/H0406/116) |
| Condition | Established Type 2 diabetes mellitus (≥ 12 months < 10 years duration) |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | HbA1c measured at 6 and 12 month follow up |
| Secondary outcome measures | 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) |
| Overall study start date | 01/07/2010 |
| Overall study end date | 30/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 640 |
| Participant 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) |
| Participant 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 |
| Recruitment start date | 26/08/2010 |
| Recruitment end date | 07/09/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Leicester
LE5 4PR
United Kingdom
Birmingham
B15 2TT
United Kingdom
Sponsor information
Hospital/treatment centre
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
| Phone | +44 116 258 4109 |
|---|---|
| carolyn.maloney@uhl-tr.nhs.uk | |
| Website | http://www.uhl-tr.nhs.uk |
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We are planning to publish the results in a high impact peer-reviewed journal with a submission date of September 2018. |
| IPD sharing plan | The datasets generated and/or analysed during the study are not expected to be made publically available due to ethical restrictions. An anonymized minimal dataset will be made available to bonafide researchers interested in collaborative research through requests sent to the lead author. |
Editorial Notes
08/07/2021: Internal review.
04/05/2018: The following changes have been made:
1. The recruitment start date has been changed from 01/07/2010 to 26/08/2010.
2. The recruitment end date has been changed from 30/09/2013 to 07/09/2012.
3. The University of Birmingham Medical School has been added as a trial site.
4. A publication and dissemination plan and intention to publish date have been added.
5. An IPD sharing statement has been added.
6. A plain English summary has been added.
20/03/2018: No publications found, verifying study status with principal investigator.
25/02/2016: No publications found, verifying study status with principal investigator.
