Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/06/2010
Date assigned
29/07/2010
Last edited
04/05/2018
Prospective/Retrospective
Prospectively 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

Prof Melanie Davies

ORCID ID

Contact details

Leicester Diabetes Centre (Broadleaf)
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 116 258 6481
melanie.davies@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

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

Acronym

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

Leicestershire, Northamptonshire & Rutland Research Ethics Committee 1 approved on the 25th February 2010 (ref: 09/H0406/116)

Study design

Multi centre cluster randomised controlled trial with randomisation at practice level.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format. Please use contact details below to request a patient information leaflet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/07/2010

Overall trial end date

30/09/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

640

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

United Kingdom

Trial participating centre

Leicester Diabetes Centre
Leicester General Hospital
Leicester
LE5 4PR
United Kingdom

Trial participating centre

Centre for Endocrinology Diabetes and Medicine
University of Birmingham Medical School
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust

Sponsor details

Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 116 258 4109
carolyn.maloney@uhl-tr.nhs.uk

Sponsor type

Hospital/treatment centre

Website

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

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care (CLAHRC)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
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.

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.