Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
DESMOND
Study hypothesis
To evaluate the effectiveness and feasibility of delivering structured group self-management education to individuals newly diagnosed with type two diabetes.
Ethics approval
Approval received from Multi-centre Research Ethics Committee (MREC) on the 16th June 2004.
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Self management of type two diabetes
Intervention
A programme of six hours of structured group education consisting of two three-hour sessions offered as either one day or two half-days, facilitated by two health care professionals trained to deliver the intervention to groups of up to ten people newly diagnosed with type two diabetes, who may be accompanied by a partner, family member or friend.
This is compared to a control group receiving enhanced routine care.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Glycaemic control as measured by HbA1c at 12 months.
Secondary outcome measures
1. Cardiovascular (CV) risk as measured by lipid profile and blood pressure
2. Quality of life indicators, diabetes control, self-care and illness belief perceptions of patients at 12 months
Overall trial start date
01/07/2004
Overall trial end date
31/01/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Greater than 18 years of age
2. Referred to the study within four weeks of diagnosis of type two diabetes
3. In intervention group, able to attend the intervention within 12 weeks of diagnosis
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
1,000
Participant exclusion criteria
1. Are unable to give informed consent
2. Have been recruited to take part, or are already taking part in other research
3. Have severe and enduring mental health problems
4. Are not primarily responsible for their own care
5. Are unable to participate in a group programme
6. Have insufficient understanding of English to participate in the group education
Recruitment start date
01/07/2004
Recruitment end date
31/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leicester Diabetes Centre (Broadleaf)
Leicester
LE5 4PW
United Kingdom
Sponsor information
Organisation
University Hospitals of Leicester NHS Trust (UK)
Sponsor details
Gwendolen House
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Diabetes UK (UK) (ref: BDA:RD04/0002922)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Department of Health (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NovoNordisk (UK) - unrestricted educational grant
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
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18276664
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22539172
Publication citations
-
Results
Davies MJ, Heller S, Skinner TC, Campbell MJ, Carey ME, Cradock S, Dallosso HM, Daly H, Doherty Y, Eaton S, Fox C, Oliver L, Rantell K, Rayman G, Khunti K, , Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial., BMJ, 2008, 336, 7642, 491-495, doi: 10.1136/bmj.39474.922025.BE.
-
Results
Khunti K, Gray LJ, Skinner T, Carey ME, Realf K, Dallosso H, Fisher H, Campbell M, Heller S, Davies MJ, Effectiveness of a diabetes education and self management programme (DESMOND) for people with newly diagnosed type 2 diabetes mellitus: three year follow-up of a cluster randomised controlled trial in primary care., BMJ, 2012, 344, e2333.