Cargando…

Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial

BACKGROUND: Paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling condition. The National Institute for Health and Clinical Excellence (NICE) recommends Cognitive Behavioural Therapy (CBT) as a treatment option for paediatric CFS/ME because th...

Descripción completa

Detalles Bibliográficos
Autores principales: Baos, Sarah, Brigden, Amberly, Anderson, Emma, Hollingworth, William, Price, Simon, Mills, Nicola, Beasant, Lucy, Gaunt, Daisy, Garfield, Kirsty, Metcalfe, Chris, Parslow, Roxanne, Downing, Harriet, Kessler, David, Macleod, John, Stallard, Paul, Knoop, Hans, Van de Putte, Elise, Nijhof, Sanne, Bleijenberg, Gijs, Crawley, Esther
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5824604/
https://www.ncbi.nlm.nih.gov/pubmed/29471861
http://dx.doi.org/10.1186/s13063-018-2500-3
_version_ 1783302059609554944
author Baos, Sarah
Brigden, Amberly
Anderson, Emma
Hollingworth, William
Price, Simon
Mills, Nicola
Beasant, Lucy
Gaunt, Daisy
Garfield, Kirsty
Metcalfe, Chris
Parslow, Roxanne
Downing, Harriet
Kessler, David
Macleod, John
Stallard, Paul
Knoop, Hans
Van de Putte, Elise
Nijhof, Sanne
Bleijenberg, Gijs
Crawley, Esther
author_facet Baos, Sarah
Brigden, Amberly
Anderson, Emma
Hollingworth, William
Price, Simon
Mills, Nicola
Beasant, Lucy
Gaunt, Daisy
Garfield, Kirsty
Metcalfe, Chris
Parslow, Roxanne
Downing, Harriet
Kessler, David
Macleod, John
Stallard, Paul
Knoop, Hans
Van de Putte, Elise
Nijhof, Sanne
Bleijenberg, Gijs
Crawley, Esther
author_sort Baos, Sarah
collection PubMed
description BACKGROUND: Paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling condition. The National Institute for Health and Clinical Excellence (NICE) recommends Cognitive Behavioural Therapy (CBT) as a treatment option for paediatric CFS/ME because there is good evidence that it is effective. Despite this, most young people in the UK are unable to access local specialist CBT for CFS/ME. A randomised controlled trial (RCT) showed FITNET was effective in the Netherlands but we do not know if it is effective in the National Health Service (NHS) or if it is cost-effective. This trial will investigate whether FITNET-NHS is clinically effective and cost-effective in the NHS. METHODS: Seven hundred and thirty-four paediatric patients (aged 11–17 years) with CFS/ ME will be randomised (1:1) to receive either FITNET-NHS (online CBT) or Activity Management (delivered via video call). The internal pilot study will use integrated qualitative methods to examine the feasibility of recruitment and the acceptability of treatment. The full trial will assess whether FITNET-NHS is clinically effective and cost-effective. The primary outcome is disability at 6 months, measured using the SF-36-PFS (Physical Function Scale) questionnaire. Cost-effectiveness is measured via cost-utility analysis from an NHS perspective. Secondary subgroup analysis will investigate the effectiveness of FITNET-NHS in those with co-morbid mood disorders. DISCUSSION: If FITNET-NHS is found to be feasible and acceptable (internal pilot) and effective and cost-effective (full trial), its provision by the NHS has the potential to deliver substantial health gains for the large number of young people suffering from CFS/ME but unable to access treatment because there is no local specialist service. This trial will provide further evidence evaluating the delivery of online CBT to young people with chronic conditions. TRIAL REGISTRATION: ISRCTN registry, registration number: ISRCTN18020851. Registered on 4 August 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2500-3) contains supplementary material, which is available to authorized users.
format Online
Article
Text
id pubmed-5824604
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-58246042018-02-26 Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial Baos, Sarah Brigden, Amberly Anderson, Emma Hollingworth, William Price, Simon Mills, Nicola Beasant, Lucy Gaunt, Daisy Garfield, Kirsty Metcalfe, Chris Parslow, Roxanne Downing, Harriet Kessler, David Macleod, John Stallard, Paul Knoop, Hans Van de Putte, Elise Nijhof, Sanne Bleijenberg, Gijs Crawley, Esther Trials Study Protocol BACKGROUND: Paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling condition. The National Institute for Health and Clinical Excellence (NICE) recommends Cognitive Behavioural Therapy (CBT) as a treatment option for paediatric CFS/ME because there is good evidence that it is effective. Despite this, most young people in the UK are unable to access local specialist CBT for CFS/ME. A randomised controlled trial (RCT) showed FITNET was effective in the Netherlands but we do not know if it is effective in the National Health Service (NHS) or if it is cost-effective. This trial will investigate whether FITNET-NHS is clinically effective and cost-effective in the NHS. METHODS: Seven hundred and thirty-four paediatric patients (aged 11–17 years) with CFS/ ME will be randomised (1:1) to receive either FITNET-NHS (online CBT) or Activity Management (delivered via video call). The internal pilot study will use integrated qualitative methods to examine the feasibility of recruitment and the acceptability of treatment. The full trial will assess whether FITNET-NHS is clinically effective and cost-effective. The primary outcome is disability at 6 months, measured using the SF-36-PFS (Physical Function Scale) questionnaire. Cost-effectiveness is measured via cost-utility analysis from an NHS perspective. Secondary subgroup analysis will investigate the effectiveness of FITNET-NHS in those with co-morbid mood disorders. DISCUSSION: If FITNET-NHS is found to be feasible and acceptable (internal pilot) and effective and cost-effective (full trial), its provision by the NHS has the potential to deliver substantial health gains for the large number of young people suffering from CFS/ME but unable to access treatment because there is no local specialist service. This trial will provide further evidence evaluating the delivery of online CBT to young people with chronic conditions. TRIAL REGISTRATION: ISRCTN registry, registration number: ISRCTN18020851. Registered on 4 August 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2500-3) contains supplementary material, which is available to authorized users. BioMed Central 2018-02-22 /pmc/articles/PMC5824604/ /pubmed/29471861 http://dx.doi.org/10.1186/s13063-018-2500-3 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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
Baos, Sarah
Brigden, Amberly
Anderson, Emma
Hollingworth, William
Price, Simon
Mills, Nicola
Beasant, Lucy
Gaunt, Daisy
Garfield, Kirsty
Metcalfe, Chris
Parslow, Roxanne
Downing, Harriet
Kessler, David
Macleod, John
Stallard, Paul
Knoop, Hans
Van de Putte, Elise
Nijhof, Sanne
Bleijenberg, Gijs
Crawley, Esther
Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial
title Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial
title_full Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial
title_fullStr Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial
title_full_unstemmed Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial
title_short Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial
title_sort investigating the effectiveness and cost-effectiveness of fitnet-nhs (fatigue in teenagers on the internet in the nhs) compared to activity management to treat paediatric chronic fatigue syndrome (cfs)/myalgic encephalomyelitis (me): protocol for a randomised controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5824604/
https://www.ncbi.nlm.nih.gov/pubmed/29471861
http://dx.doi.org/10.1186/s13063-018-2500-3
work_keys_str_mv AT baossarah investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT brigdenamberly investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT andersonemma investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT hollingworthwilliam investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT pricesimon investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT millsnicola investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT beasantlucy investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT gauntdaisy investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT garfieldkirsty investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT metcalfechris investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT parslowroxanne investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT downingharriet investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT kesslerdavid investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT macleodjohn investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT stallardpaul investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT knoophans investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT vandeputteelise investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT nijhofsanne investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT bleijenberggijs investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial
AT crawleyesther investigatingtheeffectivenessandcosteffectivenessoffitnetnhsfatigueinteenagersontheinternetinthenhscomparedtoactivitymanagementtotreatpaediatricchronicfatiguesyndromecfsmyalgicencephalomyelitismeprotocolforarandomisedcontrolledtrial