Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/11/2010
Date assigned
03/03/2011
Last edited
03/03/2016
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

Prof Melanie Davies

ORCID ID

Contact details

Leicester Diabetes Centre (Broadleaf)
Leicester General Hospital
Gwendolen road
Leicester
LE5 4PW
United Kingdom
-
melanie.davies@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UNOLE 0106

Study information

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

Acronym

Study hypothesis

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

Leicestershire Northampton and Rutland Committee 1, 07/09/2010, ref:10/H0406/54

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

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2011

Overall trial end date

30/09/2013

Reason abandoned

Eligibility

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%

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

532

Participant 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

Recruitment start date

01/01/2011

Recruitment end date

30/09/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicester Diabetes Centre (Broadleaf)
Leicester
LE5 4PW
United Kingdom

Sponsor information

Organisation

University of Leicester (UK)

Sponsor details

University Road
Leicester
LE1 7RH
United Kingdom
+44 (0)11 6252 2759
leicunive-sub@leicester.ac.uk

Sponsor type

University/education

Website

http://www2.le.ac.uk/offices/researchsupport/researchsupportoffice

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

Funder name

Leicestershire, Northamptonshire and Rutland CLARHC and CLAHRC for South Yorkshire (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes

03/03/2016: No publications found, verifying study status with principal investigator