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 measure
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 (if study stopped)
Eligibility
Participant inclusion criteria
Current participant inclusion criteria as of 04/02/2019:
1. Individuals with established Type 2 Diabetes Mellitus
2. Diabetes duration of 12 months or more
3. HbA1c between 7.8 and 11%
Previous 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
Basic results (scientific)
See additional file (ISRCTN71467886_BasicResults_4Feb19.pdf)
Publication list
Publication citations
Additional files
- ISRCTN71467886_BasicResults_4Feb19.pdf Uploaded 04/02/2019