Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care

Introduction:Fibromyalgia (FM) is a chronic condition characterized by chronic pain, fatigue and loss of function which significantly impairs quality of life. Although treatment of FM remains disputed, some studies point at the efficacy of interdisciplinary therapy. This study aims to analyze the ef...

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Autores: Caballol Angelats, Rosa|||0000-0001-5780-9888, Queiroga Gonçalves, Alessandra, Aguilar Martín, Carina|||0000-0002-2357-5726, Sancho Sol, Maria Cinta, González Serra, Gemma, Casajuana Closas, Marc|||0000-0001-5653-996X, Carrasco Querol, Noèlia|||0000-0002-5876-7082, Fernández-Sáez, José|||0000-0002-6717-7674, Dalmau Llorca, M. Rosa|||0000-0001-7537-5307, Abellana, Rosa|||0000-0003-4487-4431, Berenguera, Anna|||0000-0002-0889-2002
Tipo de recurso: artículo
Fecha de publicación:2019
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:222755
Acceso en línea:https://ddd.uab.cat/record/222755
https://dx.doi.org/urn:doi:10.1097/MD.0000000000017289
Access Level:acceso abierto
Palabra clave:Cost utility analysis
Fibromyalgia
Implementation science
Pragmatic clinical trials
Primary health care
Qualitative research
Quality of life
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spelling Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary carea mixed methods study protocolCaballol Angelats, Rosa|||0000-0001-5780-9888Queiroga Gonçalves, AlessandraAguilar Martín, Carina|||0000-0002-2357-5726Sancho Sol, Maria CintaGonzález Serra, GemmaCasajuana Closas, Marc|||0000-0001-5653-996XCarrasco Querol, Noèlia|||0000-0002-5876-7082Fernández-Sáez, José|||0000-0002-6717-7674Dalmau Llorca, M. Rosa|||0000-0001-7537-5307Abellana, Rosa|||0000-0003-4487-4431Berenguera, Anna|||0000-0002-0889-2002Cost utility analysisFibromyalgiaImplementation sciencePragmatic clinical trialsPrimary health careQualitative researchQuality of lifeIntroduction:Fibromyalgia (FM) is a chronic condition characterized by chronic pain, fatigue and loss of function which significantly impairs quality of life. Although treatment of FM remains disputed, some studies point at the efficacy of interdisciplinary therapy. This study aims to analyze the effectiveness, cost-utility and benefits of a multicomponent therapy on quality of life (main variable), functional impact, mood and pain in people suffering from FM that attend primary care centers (PCCs) of the Catalan Institute of Health (ICS).Methods and analysis:A 2-phase, mixed methods study has been designed following Medical Research Council guidance. Phase 1: Pragmatic randomized clinical trial with patients diagnosed with FM that attend one of the 11 PCCs of the ICS Gerència Territorial Terres de l'Ebre. We estimate a total sample of 336 patients. The control group will receive usual clinical care, while the multicomponent therapy group (MT group) will receive usual clinical care plus group therapy (consisting of health education, exercise and cognitive-behavioural therapy) during 12 weeks in 2-hourly weekly sessions. Analysis: the standardized mean response and the standardized effect size will be assessed at 3, 9, and 15 months after the beginning of the study using multiple linear regression models. Utility measurements will be used for the economic analysis. Phase 2: Qualitative socio constructivist study to evaluate the intervention according to the results obtained and the opinions and experiences of participants (patients and professionals). We will use theoretical sampling, with 2 discussion groups of participants in the multicomponent therapy and 2 discussion groups of professionals of different PCCs. A thematic content analysis will be carried out.Ethics and dissemination:This study protocol has been approved by the Clinical Research Ethics Committee of the Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (code P18/068). Articles will be published in international, peer-reviewed scientific journals.Trial registration:Clinical-Trials.gov: NCT04049006.Universitat Autònoma de Barcelona 22019-01-0120192019-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/222755https://dx.doi.org/urn:doi:10.1097/MD.0000000000017289reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengMinisterio de Economía y Competitividad https://doi.org/10.13039/501100003329 ISCIII/PI1800943open accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2227552026-06-06T12:50:31Z
dc.title.none.fl_str_mv Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care
a mixed methods study protocol
title Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care
spellingShingle Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care
Caballol Angelats, Rosa|||0000-0001-5780-9888
Cost utility analysis
Fibromyalgia
Implementation science
Pragmatic clinical trials
Primary health care
Qualitative research
Quality of life
title_short Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care
title_full Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care
title_fullStr Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care
title_full_unstemmed Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care
title_sort Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care
dc.creator.none.fl_str_mv Caballol Angelats, Rosa|||0000-0001-5780-9888
Queiroga Gonçalves, Alessandra
Aguilar Martín, Carina|||0000-0002-2357-5726
Sancho Sol, Maria Cinta
González Serra, Gemma
Casajuana Closas, Marc|||0000-0001-5653-996X
Carrasco Querol, Noèlia|||0000-0002-5876-7082
Fernández-Sáez, José|||0000-0002-6717-7674
Dalmau Llorca, M. Rosa|||0000-0001-7537-5307
Abellana, Rosa|||0000-0003-4487-4431
Berenguera, Anna|||0000-0002-0889-2002
author Caballol Angelats, Rosa|||0000-0001-5780-9888
author_facet Caballol Angelats, Rosa|||0000-0001-5780-9888
Queiroga Gonçalves, Alessandra
Aguilar Martín, Carina|||0000-0002-2357-5726
Sancho Sol, Maria Cinta
González Serra, Gemma
Casajuana Closas, Marc|||0000-0001-5653-996X
Carrasco Querol, Noèlia|||0000-0002-5876-7082
Fernández-Sáez, José|||0000-0002-6717-7674
Dalmau Llorca, M. Rosa|||0000-0001-7537-5307
Abellana, Rosa|||0000-0003-4487-4431
Berenguera, Anna|||0000-0002-0889-2002
author_role author
author2 Queiroga Gonçalves, Alessandra
Aguilar Martín, Carina|||0000-0002-2357-5726
Sancho Sol, Maria Cinta
González Serra, Gemma
Casajuana Closas, Marc|||0000-0001-5653-996X
Carrasco Querol, Noèlia|||0000-0002-5876-7082
Fernández-Sáez, José|||0000-0002-6717-7674
Dalmau Llorca, M. Rosa|||0000-0001-7537-5307
Abellana, Rosa|||0000-0003-4487-4431
Berenguera, Anna|||0000-0002-0889-2002
author2_role author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona
dc.subject.none.fl_str_mv Cost utility analysis
Fibromyalgia
Implementation science
Pragmatic clinical trials
Primary health care
Qualitative research
Quality of life
topic Cost utility analysis
Fibromyalgia
Implementation science
Pragmatic clinical trials
Primary health care
Qualitative research
Quality of life
description Introduction:Fibromyalgia (FM) is a chronic condition characterized by chronic pain, fatigue and loss of function which significantly impairs quality of life. Although treatment of FM remains disputed, some studies point at the efficacy of interdisciplinary therapy. This study aims to analyze the effectiveness, cost-utility and benefits of a multicomponent therapy on quality of life (main variable), functional impact, mood and pain in people suffering from FM that attend primary care centers (PCCs) of the Catalan Institute of Health (ICS).Methods and analysis:A 2-phase, mixed methods study has been designed following Medical Research Council guidance. Phase 1: Pragmatic randomized clinical trial with patients diagnosed with FM that attend one of the 11 PCCs of the ICS Gerència Territorial Terres de l'Ebre. We estimate a total sample of 336 patients. The control group will receive usual clinical care, while the multicomponent therapy group (MT group) will receive usual clinical care plus group therapy (consisting of health education, exercise and cognitive-behavioural therapy) during 12 weeks in 2-hourly weekly sessions. Analysis: the standardized mean response and the standardized effect size will be assessed at 3, 9, and 15 months after the beginning of the study using multiple linear regression models. Utility measurements will be used for the economic analysis. Phase 2: Qualitative socio constructivist study to evaluate the intervention according to the results obtained and the opinions and experiences of participants (patients and professionals). We will use theoretical sampling, with 2 discussion groups of participants in the multicomponent therapy and 2 discussion groups of professionals of different PCCs. A thematic content analysis will be carried out.Ethics and dissemination:This study protocol has been approved by the Clinical Research Ethics Committee of the Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (code P18/068). Articles will be published in international, peer-reviewed scientific journals.Trial registration:Clinical-Trials.gov: NCT04049006.
publishDate 2019
dc.date.none.fl_str_mv 2
2019-01-01
2019
2019-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/222755
https://dx.doi.org/urn:doi:10.1097/MD.0000000000017289
url https://ddd.uab.cat/record/222755
https://dx.doi.org/urn:doi:10.1097/MD.0000000000017289
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.relation.none.fl_str_mv Ministerio de Economía y Competitividad https://doi.org/10.13039/501100003329 ISCIII/PI1800943
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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