A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial

Background: Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that could reduce itching or the damage caused by scratc...

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Main Authors:	Harrison, Eleanor F., Haines, Rachel H., Cowdell, Fiona, Sach, Tracey H., Dean, Taraneh, Pollock, Ian, Burrows, Nigel P., Buckley, Hannah, Batchelor, Jonathan M., Williams, Hywel C., Lawton, Sandra, Brown, Sara J., Bradshaw, Lucy E., Ahmed, Amina, Montgomery, Alan A., Mitchell, Eleanor, Thomas, Kim S.
Format:	Article
Language:	English
Published:	BioMed Central 2015
Online Access:	http://eprints.nottingham.ac.uk/44826/ http://eprints.nottingham.ac.uk/44826/ http://eprints.nottingham.ac.uk/44826/ http://eprints.nottingham.ac.uk/44826/1/CLOTHES%20Trial%20Trials%20201516390.pdf

id	nottingham-44826
recordtype	eprints
spelling	nottingham-448262017-10-17T20:35:40Z http://eprints.nottingham.ac.uk/44826/ A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial Harrison, Eleanor F. Haines, Rachel H. Cowdell, Fiona Sach, Tracey H. Dean, Taraneh Pollock, Ian Burrows, Nigel P. Buckley, Hannah Batchelor, Jonathan M. Williams, Hywel C. Lawton, Sandra Brown, Sara J. Bradshaw, Lucy E. Ahmed, Amina Montgomery, Alan A. Mitchell, Eleanor Thomas, Kim S. Background: Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that could reduce itching or the damage caused by scratching. However, the effectiveness and cost-effectiveness of these garments in the management of eczema has yet to be proven. The CLOTHES Trial will test the hypothesis that ‘silk therapeutic garments plus standard eczema care’ is superior to ‘standard care alone’ for children with moderate to severe eczema. Methods/Design: Parallel group, observer-blind, pragmatic, multi-centre randomised controlled trial of 6 months’ duration. Three hundred children aged 1 to 15 years with moderate to severe eczema will be randomised (1:1) to receive silk therapeutic garments plus standard eczema care, or standard eczema care alone. Primary outcome is eczema severity, as assessed by trained and blinded investigators at 2, 4 and 6 months (using the Eczema Area and Severity Index (EASI)). Secondary outcomes include: patient-reported eczema symptoms (collected weekly for 6 months to capture long-term control); global assessment of severity; quality of life of the child, family and main carer; use of standard eczema treatments (emollients, corticosteroids applied topically, calcineurin inhibitors applied topically and wet wraps); frequency of infections; and cost-effectiveness. The acceptability and durability of the clothing will also be assessed, as will adherence to wearing the garments. A nested qualitative study will assess the views of a subset of children wearing the garments and their parents, and those of healthcare providers and commissioners. Randomisation uses a computer-generated sequence of permuted blocks of randomly varying size, stratified by recruiting hospital and child’s age (< 2 years; 2 to 5 years; > 5 years), and concealed using a secure web-based system. The sequence of treatment allocations will remain concealed until randomisation and data collection are complete. Recruitment is taking place from November 2013 to May 2015, and the trial will be completed in 2016. Full details of results will be published in the National Institute for Health Research Journal series. BioMed Central 2015-09-02 Article PeerReviewed application/pdf en cc_by http://eprints.nottingham.ac.uk/44826/1/CLOTHES%20Trial%20Trials%20201516390.pdf Harrison, Eleanor F. and Haines, Rachel H. and Cowdell, Fiona and Sach, Tracey H. and Dean, Taraneh and Pollock, Ian and Burrows, Nigel P. and Buckley, Hannah and Batchelor, Jonathan M. and Williams, Hywel C. and Lawton, Sandra and Brown, Sara J. and Bradshaw, Lucy E. and Ahmed, Amina and Montgomery, Alan A. and Mitchell, Eleanor and Thomas, Kim S. (2015) A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial. Trials, 16 . p. 390. ISSN 1745-6215 https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0921-9 doi:10.1186/s13063-015-0921-9 doi:10.1186/s13063-015-0921-9
repository_type	Digital Repository
institution_category	Local University
institution	University of Nottingham Malaysia Campus
building	Nottingham Research Data Repository
collection	Online Access
language	English
description	Background: Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that could reduce itching or the damage caused by scratching. However, the effectiveness and cost-effectiveness of these garments in the management of eczema has yet to be proven. The CLOTHES Trial will test the hypothesis that ‘silk therapeutic garments plus standard eczema care’ is superior to ‘standard care alone’ for children with moderate to severe eczema. Methods/Design: Parallel group, observer-blind, pragmatic, multi-centre randomised controlled trial of 6 months’ duration. Three hundred children aged 1 to 15 years with moderate to severe eczema will be randomised (1:1) to receive silk therapeutic garments plus standard eczema care, or standard eczema care alone. Primary outcome is eczema severity, as assessed by trained and blinded investigators at 2, 4 and 6 months (using the Eczema Area and Severity Index (EASI)). Secondary outcomes include: patient-reported eczema symptoms (collected weekly for 6 months to capture long-term control); global assessment of severity; quality of life of the child, family and main carer; use of standard eczema treatments (emollients, corticosteroids applied topically, calcineurin inhibitors applied topically and wet wraps); frequency of infections; and cost-effectiveness. The acceptability and durability of the clothing will also be assessed, as will adherence to wearing the garments. A nested qualitative study will assess the views of a subset of children wearing the garments and their parents, and those of healthcare providers and commissioners. Randomisation uses a computer-generated sequence of permuted blocks of randomly varying size, stratified by recruiting hospital and child’s age (< 2 years; 2 to 5 years; > 5 years), and concealed using a secure web-based system. The sequence of treatment allocations will remain concealed until randomisation and data collection are complete. Recruitment is taking place from November 2013 to May 2015, and the trial will be completed in 2016. Full details of results will be published in the National Institute for Health Research Journal series.
format	Article
author	Harrison, Eleanor F. Haines, Rachel H. Cowdell, Fiona Sach, Tracey H. Dean, Taraneh Pollock, Ian Burrows, Nigel P. Buckley, Hannah Batchelor, Jonathan M. Williams, Hywel C. Lawton, Sandra Brown, Sara J. Bradshaw, Lucy E. Ahmed, Amina Montgomery, Alan A. Mitchell, Eleanor Thomas, Kim S.
spellingShingle	Harrison, Eleanor F. Haines, Rachel H. Cowdell, Fiona Sach, Tracey H. Dean, Taraneh Pollock, Ian Burrows, Nigel P. Buckley, Hannah Batchelor, Jonathan M. Williams, Hywel C. Lawton, Sandra Brown, Sara J. Bradshaw, Lucy E. Ahmed, Amina Montgomery, Alan A. Mitchell, Eleanor Thomas, Kim S. A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial
author_facet	Harrison, Eleanor F. Haines, Rachel H. Cowdell, Fiona Sach, Tracey H. Dean, Taraneh Pollock, Ian Burrows, Nigel P. Buckley, Hannah Batchelor, Jonathan M. Williams, Hywel C. Lawton, Sandra Brown, Sara J. Bradshaw, Lucy E. Ahmed, Amina Montgomery, Alan A. Mitchell, Eleanor Thomas, Kim S.
author_sort	Harrison, Eleanor F.
title	A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial
title_short	A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial
title_full	A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial
title_fullStr	A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial
title_full_unstemmed	A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial
title_sort	multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (clothes trial): study protocol for a randomised controlled trial
publisher	BioMed Central
publishDate	2015
url	http://eprints.nottingham.ac.uk/44826/ http://eprints.nottingham.ac.uk/44826/ http://eprints.nottingham.ac.uk/44826/ http://eprints.nottingham.ac.uk/44826/1/CLOTHES%20Trial%20Trials%20201516390.pdf
first_indexed	2018-09-06T13:36:28Z
last_indexed	2018-09-06T13:36:28Z
_version_	1610865430991208448

A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial

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