DESMOND (Diabetes Education and Self Management for Ongoing and Newly Diagnosed) Ongoing Study
| ISRCTN | ISRCTN71467886 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71467886 |
| Secondary identifying numbers | UNOLE 0106 |
- Submission date
- 16/11/2010
- Registration date
- 03/03/2011
- Last edited
- 04/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Melanie Davies
Scientific
Scientific
Leicester Diabetes Centre (Broadleaf)
Leicester General Hospital
Gwendolen road
Leicester
LE5 4PW
United Kingdom
| melanie.davies@uhl-tr.nhs.uk |
Study information
| Study design | Multicentre cluster randomised controlled trial with randomisation at the level of the GP Practice |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format. Please use contact details below to request a patient information leaflet |
| Scientific title | To test an integrated approach for promoting effective self management in people with established Type 2 Diabetes Mellitus (T2DM): a cluster randomised controlled trial of the DESMOND Ongoing education programme |
| Study objectives | An approach integrating ongoing self-management education with clinical management in those with established Type 2 Diabetes Mellitus (T2DM) within a primary care setting will improve glycaemic control, other biomedical parameters and patient level outcomes |
| Ethics approval(s) | Leicestershire Northampton and Rutland Committee 1, 07/09/2010, ref:10/H0406/54 |
| Health condition(s) or problem(s) studied | Type 2 diabetes mellitus (T2DM) |
| Intervention | Patients in the intervention group will receive the following: 1. DESMOND Foundation. An existing DESMOND 6-hour group education course which provides introductory information for managing type-2 diabetes 2. Six group sessions of DESMOND-Ongoing (4 in the 1st year and 2 in the 2nd year) delivered by specially trained DESMOND Educators which concentrate on developing self-management skills in people with established type-2 diabetes and covers specific topics related to type-2 diabetes including diet, exercise, managing hypo- and hyper-glycaemia 3. Two Care Planning sessions (delivered at yearly intervals) delivered at the level of the GP Practice by trained GPs and/or Practice Nurses. Care Planning focuses on 'looking with rather than at' someone with diabetes to plan their care and areas for improvement over the forthcoming year. Patients are helped to identify goals and make action plans to acheive these. The healthcare professionals delivering the Care Planning sessions will first be given in-depth training in Care Planning by DESMOND Eductors within the study group. The intervention is a rolling intervention. In the real world it will comprise a six hour introductory session (DESMOND Foundation), a Care Planning session, and then four rolling sessions of DESMOND ongoing delivered at 6 monthly intervals (meaning that the complete material is delivered in 2 years. However, for the trial we are condensing the intervention during the first years as a proof of concept and then will change to the frequency that it would be delivered in the real world during the 2nd year. Therefore intervention patients will receive the six sessions mentioned above during the first year and then a further Care Planning session and 2 sessions of Going Forward with Diabetes during the 2nd year. |
| Intervention type | Behavioural |
| Primary outcome measure | Reduction in HbA1c at 24 months |
| Secondary outcome measures | 1. Reduction in the following biomedical measures measured at 12 and 24 months 1.1. HbA1c (at 12 months) 1.2. Cholesterol (total, HDL and LDL) 1.3. Triglyceride 1.4. Blood pressure (BP) Systolic 1.5. BP Diastolic 1.6. Weight 1.7. Waist circumference 1.8. Hip circumference 2. Improvement in the following scores at 12 and 24 months 2.1. EQ5D 2.2. Illness Perceptions Questionnaire revised 2.3. Diabetes Illness Representations Questionnaire 2.4. Summary of Diabetes Self Care Activities questionnaire 2.5. Hospital Anxiety and Depression Score 2.6. Problem Areas in Diabetes Score 2.7. International Physical Activity Questionnaire |
| Overall study start date | 01/01/2011 |
| Completion date | 30/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 532 |
| Key inclusion criteria | Current participant inclusion criteria as of 04/02/2019: 1. Individuals with established Type 2 Diabetes Mellitus 2. Diabetes duration of 12 months or more 3. HbA1c between 7.8 and 11% Previous participant inclusion criteria: 1. Individuals with established Type 2 Diabetes Mellitus 2. Diabetes duration of 12 months or more 3. HbA1c between 7.0 and 11% |
| Key exclusion criteria | 1. Receiving insulin therapy 2. Have existing comorbidities that could interfere with participation in the study over the 24 months 3. Unable to give informed consent 4. Severe and enduring mental health problems 5. Patients who are not primarily responsible for their own care 6. Unable to participate in a group programme (e.g. housebound) 7. Insufficient understanding of English to participate in the group education 8. Visually impaired or hard of hearing to the level that they can not participate in the group education 9. Aged under 18 years |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 30/09/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leicester Diabetes Centre (Broadleaf)
Leicester
LE5 4PW
United Kingdom
LE5 4PW
United Kingdom
Sponsor information
University of Leicester (UK)
University/education
University/education
University Road
Leicester
LE1 7RH
England
United Kingdom
| Phone | +44 (0)11 6252 2759 |
|---|---|
| leicunive-sub@leicester.ac.uk | |
| Website | http://www2.le.ac.uk/offices/researchsupport/researchsupportoffice |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care (CLAHRC)
No information available
Leicestershire, Northamptonshire and Rutland CLARHC and CLAHRC for South Yorkshire (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 04/02/2019 | 04/02/2019 | No | No |
Additional files
- ISRCTN71467886_BasicResults_4Feb19.pdf
- Uploaded 04/02/2019
Editorial Notes
04/02/2019: The following changes were made:
1. The basic results of this trial were uploaded as an additional file.
2. The participant inclusion criteria was updated.
27/04/2018: No publications found, verifying study status with principal investigator
03/03/2016: No publications found, verifying study status with principal investigator
