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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

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, Thanos Karatzias

Published in: Trials | Issue 1/2015

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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.
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Metadata
Title
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
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
Thanos Karatzias
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0644-y

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