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A study protocol for a pilot randomised trial of a structured education programme for the self-management of Type 2 diabetes for adults with intellectual disabilities

Taggart, Laurence; Coates, Vivien; Clarke, Mike; Bunting, Brendan; Davies, Melanie; Carey, Marian; Northway, Ruth; Brown, Michael; Truesdale-Kennedy, Maria; Martin-Stacey, Lorraine; Scott, Gillian; Karatzias, Thanos

Authors

Laurence Taggart

Vivien Coates

Mike Clarke

Brendan Bunting

Melanie Davies

Marian Carey

Ruth Northway

Michael Brown

Maria Truesdale-Kennedy

Lorraine Martin-Stacey

Gillian Scott



Abstract

Background: The 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/Design: This 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.
Discussion: The 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 registration: Registered with International Standard Randomised Controlled Trial (identifier: ISRCTN93185560) on
10 November 2014.

Journal Article Type Article
Acceptance Date Mar 11, 2015
Online Publication Date Apr 10, 2015
Publication Date 2015
Deposit Date Apr 21, 2015
Publicly Available Date Apr 21, 2015
Journal Trials
Print ISSN 1745-6215
Electronic ISSN 1745-6215
Publisher BMC
Peer Reviewed Peer Reviewed
Volume 16
Pages 148
DOI https://doi.org/10.1186/s13063-015-0644-y
Keywords Intellectual disability; type 2 diabetes; self-management; structured education;
Public URL http://researchrepository.napier.ac.uk/id/eprint/7769
Publisher URL http://dx.doi.org/10.1186/s13063-015-0644-y
Contract Date Apr 21, 2015

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