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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

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. Howeve...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4404014/
https://www.ncbi.nlm.nih.gov/pubmed/25872928
http://dx.doi.org/10.1186/s13063-015-0644-y
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author 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
author_facet 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
author_sort Taggart, Laurence
collection PubMed
description 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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spelling pubmed-44040142015-04-21 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 Trials Study Protocol 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. BioMed Central 2015-04-10 /pmc/articles/PMC4404014/ /pubmed/25872928 http://dx.doi.org/10.1186/s13063-015-0644-y Text en © Taggart et al.; licensee BioMed Central. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
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
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4404014/
https://www.ncbi.nlm.nih.gov/pubmed/25872928
http://dx.doi.org/10.1186/s13063-015-0644-y
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