Title: The clinical and cost-effectiveness of the DESMOND-ID education programme for adults with intellectual disability and Type 2 Diabetes
Funder: Public Health Agency, NI

Abstract: Aims: We want to find the best way to help people with a learning or intellectual disability who have Type 2 Diabetes. We will test whether providing some structured education around managing their diabetes and maintaining healthier lifestyles (diet, exercise) helps people with intellectual disabilities to manage their blood sugar and to stay healthier in the future._x000D_ Background to the research: People with intellectual disabilities are more likely to develop Type 2 Diabetes. They tend to develop it at a younger age and are less likely to have access to appropriate support that would help them to manage the condition. This may make it more likely that they will have other health problems, such as heart or kidney disease and strokes, and die younger._x000D_ What are we going to do? We have developed an education programme called DESMOND-ID, which is about diabetes and is suitable for adults with intellectual disabilities and their family member, carer, partner or friend. The programme lasts 7 weeks, two and a half hours per week, followed by two booster sessions at 3 and 5 months. The adult with intellectual disability and their family member, carer, partner or friend are encouraged to attend together. The programme supports people to better manage their diabetes. We have already done a small study which showed that the programme can be delivered and is acceptable to the adults with intellectual disability and their supports. We now need to do a larger research study to find out if our programme brings about health benefits for adults with intellectual disabilities who have Type 2 Diabetes. For example, we want to see the effects on people’s diets, physical activity and diabetes control (blood sugar)._x000D_ To test the programme, we will conduct a randomised trial. We will recruit 450 adults with intellectual disabilities who have Type 2 Diabetes, from Northern Ireland, Scotland and England (Leicestershire). With their permission, half will be randomly chosen to receive the diabetes education (DESMOND-ID) while the others continue with their usual care. We will measure everyone’s blood sugar (HbA1c) when they are recruited and twice more later in the study. We will then compare the results for the people allocated to the programme and those in the control group. We also compare other things between the groups, such as blood pressure, cholesterol, weight, and health and well being measures; and carry out an economic evaluation to see if DESMOND-ID is good value for money._x000D_ Our study has two stages and will last four years. The first stage will be a pilot trial to check that enough people will join the study. If successful, we will move to the second stage, the main trial. _x000D_ Patient and public involvement: CAN, a local intellectual disability charity in Northern Ireland, has already helped us to develop this proposal. We also did a survey with 38 adults with intellectual disabilities and Type 2 Diabetes and used their answers to design the study. We are grateful for their committed and ongoing support and we will continue to work closely with our PPI stakeholders (CAN, Diabetes UK, Mencap)._x000D_ Dissemination: Our PPI group will help us to disseminate the results of this study nationally to service users, families and staff. We will work with Professor Khunti and Diabetes UK to influence policy and practice. If DESMOND-ID is effective, we will do our best to help it become standard practice for people across the UK.

Lay abstract: Research question: Does a diabetes education programme tailored specifically for people with intellectual disability (ID) improve self-management of Type 2 diabetes (T2D) compared to usual care?_x000D_ Background: T2D is 2-3 times more common in people with ID than the general population. People with ID/T2D are not offered diabetes education as recommended by NICE that is routinely offered to the general population. This may be partly because UK diabetes education programmes are not tailored for people with ID. _x000D_ In an earlier Diabetes UK funded feasibility study, we successfully adapted a self-management education programme (DESMOND) for adults with ID (creating DESMOND-ID) and showed that we can deliver this to adults with ID/T2D. We now propose a larger study to test if DESMOND-ID has the same benefits for adults with ID that the DESMOND studies have shown for non-disabled adults, thereby improving the health of this population and reducing health inequalities._x000D_ Aims and objectives: Our primary aim is to determine the effects of DESMOND-ID versus usual care on HbA1c at 6 months in adults with ID/T2D_x000D_ Our secondary objectives will determine the effects of DESMOND-ID on biomedical and cardiovascular disease risk factors, depression, understanding of T2D, and healthy lifestyle factors and behaviour change, at 6 and 12 months as well as assessing its cost-effectiveness. Our process evaluation will identify facilitators, barriers and mechanisms involved in the DESMOND-ID process_x000D_ Methods: This will be a 2-stage randomised trial with an internal pilot, economic and process evaluations across 8 UK sites. Stage 1 (internal pilot) will run for 10 months in 3 sites (N Ireland, Leicester and Glasgow), and aim to recruit 108 participants (36 per site: 18 intervention, 18 control). The DESMOND-ID programme will be delivered over 7 weeks, 2½ hours/week, with 6-8 adults with ID/T2D and their family member, carer, partner or friend in each group, followed by booster sessions at 1 and 3 months. Each site will deliver the programme to 3 groups during the pilot. If we achieve the progression criteria, Stage 1 will run seamlessly into Stage 2 (full trial), opening all 8 sites, recruiting an additional 342 adults with ID/T2D, and conducting the process and economic evaluations_x000D_ Timelines for delivery: The study will last 45 month. Ethics, staff appointments and protocol development will begin 3mths pre-trial and run into the first 6mths to allow time for set up and opening the 3 pilot sites. The internal pilot will last 10mths (m5-14). If we achieve the progression criteria, we will continue into the main trial (m15), opening the remaining sites and recruiting 342 more adults with ID/T2D, with 6 and 12mth follow-up concluding in month 37 (m15-37). The study will finish with data cleaning and analysis (m40-42), site close-down and reporting (m40-45)_x000D_ Anticipated impact and dissemination: If DESMOND-ID is shown to be effective, the study’s main impact should be its adoption as standard practice for this ID population across the UK. Dissemination will include a report to the funder, a user-friendly report, social media/blogs, research publications and conference presentations, and presentations to service user and carer groups. We will work with our PPI partners and national professional stakeholders (Diabetes UK, Public Health England, Scottish Learning Disability Consortium) to inform policy and practice (NICE/SCIE).

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH;METABOLIC AND ENDOCRINE