Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND) Lay Educator Study

ISRCTN	ISRCTN99350009
DOI	https://doi.org/10.1186/ISRCTN99350009
Protocol serial number	1
Sponsor	University Hospitals of Leicester NHS Trust (UK)
Funder	Diabetes UK (UK)

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

DESMOND Project Office
Ward 38
Level 6 Windsor Building
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Email	marian.carey@uhl-tr.nhs.uk

Study information

Primary study design	Interventional
Study design	Open label parallel trial
Secondary study design	Non randomised study
Study type	Participant 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(s)	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).
Key secondary outcome measure(s)	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
Completion date	01/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Leicester Royal Infirmary

Leicester
LE1 5WW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes