Abstract
BackgroundThe need for structured education programmes for type 2 diabetes is a high priority for many governments around the world. One such national education programme in the United Kingdom is the DESMOND Programme, which has been shown to be robust and effective for patients in general. However, these programmes are not generally targeted to people with intellectual disabilities (ID), and robust evidence on their effects for this population is lacking. We have adapted the DESMOND Programme for people with ID and type 2 diabetes to produce an amended programme known as DESMOND-ID.This protocol is for a pilot trial to determine whether a large-scale randomised trial is feasible, to test if DESMOND-ID is more effective than usual care in adults with ID for self-management of their type 2 diabetes, in particular as a means to reduce glycated haemoglobin (Hb1Ac), improve psychological wellbeing and quality of life and promote a healthier lifestyle. This protocol describes the rationale, methods, proposed analysis plan and organisational and administrative details.Methods/DesignThis trial is a two arm, individually randomised, pilot trial for adults with ID and type 2 diabetes, and their family and/or paid carers. It compares the DESMOND-ID programme with usual care. Approximately 36 adults with mild to moderate ID will be recruited from three countries in the United Kingdom. Family and/or paid carers may also participate in the study. Participants will be randomly assigned to one of two conditions using a secure computerised system with robust allocation concealment. A range of data will be collected from the adults with ID (biomedical, psychosocial and self-management strategies) and from their carers. Focus groups with all the participants will assess the acceptability of the intervention and the trial.DiscussionThe lack of appropriate structured education programmes and educational materials for this population leads to secondary health conditions and may lead to premature deaths. There are significant benefits to be gained globally, if structured education programmes are adapted and shown to be successful for people with ID and other cognitive impairments.Trial registrationRegistered with International Standard Randomised Controlled Trial (identifier: ISRCTN93185560) on 10 November 2014.
Highlights
The need for structured education programmes for type 2 diabetes is a high priority for many governments around the world
The lack of appropriate structured education programmes and educational materials for this population leads to secondary health conditions and may lead to premature deaths
Limited information exists on the incidence of diabetes in people with intellectual disabilities (ID), McVilly et al [20] in a systematic review reported that people with ID are more likely to develop Type 2 diabetes (T2D) compared to their non-ID peers: approximately 8% rather than 4% in the non-disabled population [15]
Summary
This is the first intervention study addressing structured diabetes education for adults with ID which is simultaneously targeting family and paid carers. The National Institute for Health and Care Excellence Diabetes Guidelines (21) emphasises the importance of being offered a place on a structured education programme within six months of being diagnosed with T2D, in order to better selfmanage and avoid complications. The Convention [37] further states that parties shall ‘provide persons with disabilities with the same range, quality and standard of free or affordable healthcare and programmes as provided to other persons, including population-based public health programmes’. People with ID have had very few opportunities to participate in randomised trials about their healthcare This protocol is novel because it will include adults with ID and, where appropriate, their carers, and this will promote self-determination, independence and better self-management strategies. All authors revised the manuscript and have read and approved the final version
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