The study is being run in collaboration with Birmingham and Black Countries CLAHRC. The study is a randomised controlled trial and will evaluate the effectiveness of the DESMOND Foundation Programme in a population of mixed ethnic origin (50% South Asian)
The DESMOND programme, is now established in over 80 primary care organisations in the UK and Eire, including Leicester City PCT.
DESMOND meets national standards for a structured education programme for people with T2DM and the randomised control trial of the DESMOND newly diagnosed programme in 2005/2006 demonstrated that the programme has the potential to improve patient outcomes by positive changes in illness beliefs, weight reduction, smoking cessation, reduction in levels of depression and increased levels of physical activity and a decrease in cardiovascular risk score.
This study is being conducted to establish whether the DESMOND newly diagnosed programme can be modified for use in a multiethnic population with established T2DM (>12 mths DESMOND Foundation programme.
Both the Newly Diagnosed and the Foundation programmes have been adapted for people from the South Asian community. These programmes are supported by culturally relevant resources and importantly can be delivered by trained educators, supported by interpreters where educators with relevant language skills are not available.
The study is a cluster randomised controlled trial with randomisation at practice level. In order to test the intervention in a multi-ethnic population, the study will be run in a primary care setting in Leicester and Birmingham.
Participants will receive standard routine care in the control arm, or standard routine care plus the DESMOND Foundation Programme in the intervention arm. The final analysis and study report is scheduled for publication in spring/summer 2012
The original RCT showed the effectiveness of DESMOND in patients newly diagnosed with diabetes (Davies et al, 2007). The present study is investigating the effectiveness of the Foundation programme in people with established diabetes.
To make the results generalisable, a mixed ethnic population is being studied. The study is a cluster randomised controlled trial with randomisation at practice level. Sixteen practices will be recruited (8 in South Birmingham PCT and 8 In Leicester City PCT). In total 320 people will be recruited to the study (40 per practice).
The primary outcome variable is HbA1c with follow-up at 6 and 12 months.
The protocol has received ethical approval and we are waiting for research governance approval. We are currently recruiting practices and setting up study procedures. We plan to start recruitment in June.
emer.brady@uhl-tr.nhs.uk or helen.dallosso@uhl-tr.nhs.uk