Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson's symptoms against other clinical monitoring methods

In recent years, multiple studies have aimed to develop and validate portable technological devices capable of monitoring the motor complications of Parkinson's disease patients (Parkinson's Holter). The effectiveness of these monitoring devices for improving clinical control is not known....

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Autores: Rodríguez-Molinero, Alejandro|||0000-0002-9678-2654, Hernández-Vara, Jorge|||0000-0002-9129-5224, Miñarro, Antonio, Pérez-López, Carlos|||0000-0001-7400-4360, Bayés, Àngels|||0000-0001-9542-804X, Martínez-Castrillo, Juan Carlos|||0000-0001-7744-6850, Pérez-Martínez, David Andrés|||0000-0001-5587-0415
Tipo de recurso: artículo
Fecha de publicación:2021
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:256522
Acceso en línea:https://ddd.uab.cat/record/256522
https://dx.doi.org/urn:doi:10.1136/bmjopen-2020-045272
Access Level:acceso abierto
Palabra clave:Parkinson's disease
Neurology
Clinical trials
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spelling Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson's symptoms against other clinical monitoring methodsstudy protocolRodríguez-Molinero, Alejandro|||0000-0002-9678-2654Hernández-Vara, Jorge|||0000-0002-9129-5224Miñarro, AntonioPérez-López, Carlos|||0000-0001-7400-4360Bayés, Àngels|||0000-0001-9542-804XMartínez-Castrillo, Juan Carlos|||0000-0001-7744-6850Pérez-Martínez, David Andrés|||0000-0001-5587-0415Parkinson's diseaseNeurologyClinical trialsIn recent years, multiple studies have aimed to develop and validate portable technological devices capable of monitoring the motor complications of Parkinson's disease patients (Parkinson's Holter). The effectiveness of these monitoring devices for improving clinical control is not known. This is a single-blind, cluster-randomised controlled clinical trial. Neurologists from Spanish health centres will be randomly assigned to one of three study arms (1:1:1): (a) therapeutic adjustment using information from a Parkinson's Holter that will be worn by their patients for 7 days, (b) therapeutic adjustment using information from a diary of motor fluctuations that will be completed by their patients for 7 days and (c) therapeutic adjustment using clinical information collected during consultation. It is expected that 162 consecutive patients will be included over a period of 6 months. The primary outcome is the efficiency of the Parkinson's Holter compared with traditional clinical practice in terms of Off time reduction with respect to the baseline (recorded through a diary of motor fluctuations, which will be completed by all patients). As secondary outcomes, changes in variables related to other motor complications (dyskinesia and freezing of gait), quality of life, autonomy in activities of daily living, adherence to the monitoring system and number of doctor-patient contacts will be analysed. The noninferiority of the Parkinson's Holter against the diary of motor fluctuations in terms of Off time reduction will be studied as the exploratory objective. Ethics and dissemination approval for this study has been obtained from the Hospital Universitari de Bellvitge Ethics Committee. The results of this study will inform the practical utility of the objective information provided by a Parkinson's Holter and, therefore, the convenience of adopting this technology in clinical practice and in future clinical trials. We expect public dissemination of the results in 2022.Universitat Autònoma de Barcelona 22021-01-0120212021-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/256522https://dx.doi.org/urn:doi:10.1136/bmjopen-2020-045272reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengInstituto de Salud Carlos III https://doi.org/10.13039/501100004587 DTS17/00195open 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, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2565222026-06-06T12:50:31Z
dc.title.none.fl_str_mv Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson's symptoms against other clinical monitoring methods
study protocol
title Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson's symptoms against other clinical monitoring methods
spellingShingle Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson's symptoms against other clinical monitoring methods
Rodríguez-Molinero, Alejandro|||0000-0002-9678-2654
Parkinson's disease
Neurology
Clinical trials
title_short Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson's symptoms against other clinical monitoring methods
title_full Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson's symptoms against other clinical monitoring methods
title_fullStr Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson's symptoms against other clinical monitoring methods
title_full_unstemmed Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson's symptoms against other clinical monitoring methods
title_sort Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson's symptoms against other clinical monitoring methods
dc.creator.none.fl_str_mv Rodríguez-Molinero, Alejandro|||0000-0002-9678-2654
Hernández-Vara, Jorge|||0000-0002-9129-5224
Miñarro, Antonio
Pérez-López, Carlos|||0000-0001-7400-4360
Bayés, Àngels|||0000-0001-9542-804X
Martínez-Castrillo, Juan Carlos|||0000-0001-7744-6850
Pérez-Martínez, David Andrés|||0000-0001-5587-0415
author Rodríguez-Molinero, Alejandro|||0000-0002-9678-2654
author_facet Rodríguez-Molinero, Alejandro|||0000-0002-9678-2654
Hernández-Vara, Jorge|||0000-0002-9129-5224
Miñarro, Antonio
Pérez-López, Carlos|||0000-0001-7400-4360
Bayés, Àngels|||0000-0001-9542-804X
Martínez-Castrillo, Juan Carlos|||0000-0001-7744-6850
Pérez-Martínez, David Andrés|||0000-0001-5587-0415
author_role author
author2 Hernández-Vara, Jorge|||0000-0002-9129-5224
Miñarro, Antonio
Pérez-López, Carlos|||0000-0001-7400-4360
Bayés, Àngels|||0000-0001-9542-804X
Martínez-Castrillo, Juan Carlos|||0000-0001-7744-6850
Pérez-Martínez, David Andrés|||0000-0001-5587-0415
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona
dc.subject.none.fl_str_mv Parkinson's disease
Neurology
Clinical trials
topic Parkinson's disease
Neurology
Clinical trials
description In recent years, multiple studies have aimed to develop and validate portable technological devices capable of monitoring the motor complications of Parkinson's disease patients (Parkinson's Holter). The effectiveness of these monitoring devices for improving clinical control is not known. This is a single-blind, cluster-randomised controlled clinical trial. Neurologists from Spanish health centres will be randomly assigned to one of three study arms (1:1:1): (a) therapeutic adjustment using information from a Parkinson's Holter that will be worn by their patients for 7 days, (b) therapeutic adjustment using information from a diary of motor fluctuations that will be completed by their patients for 7 days and (c) therapeutic adjustment using clinical information collected during consultation. It is expected that 162 consecutive patients will be included over a period of 6 months. The primary outcome is the efficiency of the Parkinson's Holter compared with traditional clinical practice in terms of Off time reduction with respect to the baseline (recorded through a diary of motor fluctuations, which will be completed by all patients). As secondary outcomes, changes in variables related to other motor complications (dyskinesia and freezing of gait), quality of life, autonomy in activities of daily living, adherence to the monitoring system and number of doctor-patient contacts will be analysed. The noninferiority of the Parkinson's Holter against the diary of motor fluctuations in terms of Off time reduction will be studied as the exploratory objective. Ethics and dissemination approval for this study has been obtained from the Hospital Universitari de Bellvitge Ethics Committee. The results of this study will inform the practical utility of the objective information provided by a Parkinson's Holter and, therefore, the convenience of adopting this technology in clinical practice and in future clinical trials. We expect public dissemination of the results in 2022.
publishDate 2021
dc.date.none.fl_str_mv 2
2021-01-01
2021
2021-01-01
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/256522
https://dx.doi.org/urn:doi:10.1136/bmjopen-2020-045272
url https://ddd.uab.cat/record/256522
https://dx.doi.org/urn:doi:10.1136/bmjopen-2020-045272
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.relation.none.fl_str_mv Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 DTS17/00195
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc/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-nc/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
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repository.mail.fl_str_mv
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