Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/12/2009
Date assigned
01/02/2010
Last edited
22/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marian Carey

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

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

Acronym

Study hypothesis

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

Leicestershire, Northamptonshire and Rutland Research Ethics Committee 1, 19/08/2009, ref: 09/H0406/87

Study design

Open label parallel trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Change in coherence score. This is an illness belief score which provides a measure of an individual’s 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 trial start date

08/01/2010

Overall trial end date

01/09/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

256

Participant 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)

Recruitment start date

08/01/2010

Recruitment end date

01/09/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

Gwendolen Road
Leicester
LE5 4PW
United Kingdom
-
carolyn.maloney@uhl-tr.nhs.uk

Sponsor type

Government

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Charity

Funder name

Diabetes UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25258417
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/24798205

Publication citations

  1. Results

    Mandalia PK, Stone MA, Davies MJ, Khunti K, Carey ME, Diabetes self-management education: acceptability of using trained lay educators., Postgrad Med J, 2014, 90, 1069, 638-642, doi: 10.1136/postgradmedj-2014-132865.

  2. Results

    Carey ME, Mandalia PK, Daly H, Gray LJ, Hale R, Martin Stacey L, Taub N, Skinner TC, Stone M, Heller S, Khunti K, Davies MJ, Increasing capacity to deliver diabetes self-management education: results of the DESMOND lay educator non-randomized controlled equivalence trial, Diabet Med, 2014, 31, 11, 1431-1438, doi: 10.1111/dme.12483.

Additional files

Editorial Notes