Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND) Lay Educator Study
| ISRCTN | ISRCTN99350009 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99350009 |
| Secondary identifying numbers | 1 |
- Submission date
- 22/12/2009
- Registration date
- 01/02/2010
- Last edited
- 22/06/2015
- 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
Dr Marian Carey
Scientific
Scientific
DESMOND Project Office
Ward 38
Level 6 Windsor Building
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
| marian.carey@uhl-tr.nhs.uk |
Study information
| Study design | Open label parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Testing a newly-developed training programme for lay educators delivering the Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND) programme |
| Study objectives | 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. |
| Ethics approval(s) | Leicestershire, Northamptonshire and Rutland Research Ethics Committee 1, 19/08/2009, ref: 09/H0406/87 |
| Health condition(s) or problem(s) studied | Diabetes |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Change in coherence score. This is an illness belief score which provides a measure of an individuals understanding of their diabetes and is determined using a validated tool, the Diabetes Illness Perceptions Questionnaire (IPQ-R). |
| Secondary outcome measures | 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 |
| Overall study start date | 08/01/2010 |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 256 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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) |
| Date of first enrolment | 08/01/2010 |
| Date of final enrolment | 01/09/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
LE1 5WW
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
| carolyn.maloney@uhl-tr.nhs.uk | |
| Website | http://www.uhl-tr.nhs.uk/ |
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Charity
Diabetes UK (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- DIABETES UK LIMITED, British Diabetic Association
- Location
- United Kingdom
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? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2014 | Yes | No | |
| Results article | results | 01/11/2014 | Yes | No |
