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

BMJ Open, Vol. 11 (2021)

Mots clés
Auteurs
  • Juan Carlos Martinez-Castrillo
  • Movement Disorders and Neurodegenerative Unit, Service of Neurology, IRYCIS. Hospital Ramon y Cajal, Madrid 28034, Spain
  • Maria Alvarez
  • Clinical Prevention Services, British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada
  • Dolores Vilas
  • 1 Movement Disorders Unit, Neurology Service, Hospital Clínic de Barcelona, Barcelona, Spain
  • Ernest Balaguer
  • 1 Interventional Neuroradiology, Hospital General de Cataluña, Sant Cugat del Vallès, Spain
  • Ignacio Alvarez
  • Jon Infante
  • 1Services of Neurology, University Hospital “Marqués de Valdecilla” (IFIMAV), University of Cantabria, Santander, Spain
  • Silvia Jesús
  • Unidad de Trastornos del Movimiento, Servicio de Neurología y Neurofisiología Clínica, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Seville, Spain
  • Marina Mata
  • 5Department of Neurology, Hospital Infanta Sofia, Madrid, Spain
  • Pablo Mir
  • 8Unidad de Trastornos del Movimiento, Servicio de Neurología y Neurofisiología Clínica, Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Seville, Spain
  • Pau Pastor
  • María Sierra
  • Lydia Vela
  • 3Department of Neurology, Hospital Fundacion Alcorcon, Madrid, Spain
  • Isabel Gonzalez
  • Newcastle University, James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
  • Ana Rita Santos
  • Daniel Lopez
  • 10 Emergency Training Center, Cugy, Switzerland
  • Antonio Hernández
  • Francisco Perez
  • University Hospital Of North Durham, Durham, UK
  • Nuria Caballol
  • 9Hospital de Sant Joan Despí Moisès Broggi, Sant Joan Despí (Barcelona) Spain
  • Antonio Salvador
  • Cardiology Unit, Hospital Universitario La Fe, Valencia, Spain
  • Judith Jimenez
  • Socios En Salud Sucursal Peru, Lima, Peru
  • Alejandro Rodríguez-Molinero
  • Àrea de Recerca, Consorci Sanitari de l'Alt Penedès i Garraf, Vilafranca del Pendès, Spain
  • Jorge Hernández-Vara
  • Department of Neurology, Hospital Universitari Vall d'Hebron and Neurodegenerative Diseases Research Group, Barcelona, Spain
  • Antonio Miñarro
  • Department of Genetics, Microbiology and Statistics, Faculty of Biology, Universitat de Barcelona, Barcelona, Spain
  • Carlos Pérez-López
  • Àrea de Recerca, Consorci Sanitari de l'Alt Penedès i Garraf, Vilafranca del Pendès, Spain
  • Àngels Bayes-Rusiñol
  • Parkinson's and Movement Disorders Unit, Hospital Quirón Teknon, Barcelona, Spain
  • David A Pérez-Martínez
  • Neurology Service, Hospital Universitario 12 de Octubre, Madrid, Spain
  • Anna Planas-Ballvé
  • Mariateresa Buongiorno
  • Núria López
  • Mª Isabel Morales
  • Gema Sánchez
  • María Asunción Ávila
  • Anna Prats
  • Alexandre Gironell
  • Álvaro Sánchez-Ferro
  • Antonio Méndez
  • Elisabet Franquet
  • Sonia Escalante
  • Laura Muñoz-Delgado
  • Daniel Macías-García
  • Astrid Adarmes-Gómez
  • José Mª Salom
  • Silvia Martí
  • Carlos Leiva
  • Victor M. Puente
  • Irene Navalpotro
  • Sara Lucas
  • Antonio Koukoulis
  • Mª Gema Alonso
  • Mª Esther Cubo
  • Mª Victoria Sánchez
  • Carmen Borrúe
  • Mª Concepción Jimeno
  • Mª José Gómez
  • Lina Carazo
  • Alfredo López
  • Mª Pilar Solís
  • Rubén Alonso
  • Jessica González
  • Javier Ruiz
  • Ana Vinagre
  • Ioana Croitoru
  • Pilar Sánchez
  • Elisa Gamo
  • Sabela Novo
  • Esteban Peña
  • Esther Blanco
  • Rafael García
  • José López
  • Teresa Muñoz
  • Lucía Flores
  • Rocío García-Ramos
  • Eva López
  • Lourdes Ispierto
  • Ramiro Álvarez
  • Esther Catena
  • Berta Solano
  • Anna Cots
  • Lydia López Manzanares
  • Marta Recio-Bermejo

Résumé

Introduction 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.Methods and analysis 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.Trial registration NCT04176302; https://clinicaltrials.gov/show/NCT04176302

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