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
| العنوان: | 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 |
|---|---|
| المؤلفون: | Juan Carlos Martinez-Castrillo, Dolores Vilas, Ernest Balaguer, Ignacio Alvarez, Jon Infante, Silvia Jesús, Marina Mata, Pablo Mir, Pau Pastor, María Sierra, Lydia Vela, Isabel Gonzalez, Ana Rita Santos, Daniel Lopez, Antonio Hernández, Francisco Perez, Nuria Caballol, Antonio Salvador, Judith Jimenez, Alejandro Rodríguez-Molinero, Jorge Hernández-Vara, Antonio Miñarro, Carlos Pérez-López, Àngels Bayes-Rusiñol, David A Pérez-Martínez, 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 |
| المساهمون: | Universidad de Cantabria |
| المصدر: | BMJ open 2021; 11(7): e045272. UCrea Repositorio Abierto de la Universidad de Cantabria Universidad de Cantabria (UC) Dipòsit Digital de la UB Universidad de Barcelona BMJ Open BMJ Open, Vol 11, Iss 7 (2021) |
| بيانات النشر: | BMJ Publishing Group Ltd, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | medicine.medical_specialty, Neurology, Parkinson's disease, Activities of daily living, Clinical trials, Quality of life, Malaltia de Parkinson, Activities of Daily Living, Humans, Multicenter Studies as Topic, Medicine, Single-Blind Method, Gait Disorders, Neurologic, Randomized Controlled Trials as Topic, Protocol (science), clinical trials, business.industry, Parkinson Disease, General Medicine, medicine.disease, Gait, Clinical trial, Treatment Outcome, Dyskinesia, Quality of Life, Physical therapy, medicine.symptom, business, Assaigs clínics |
| الوصف: | 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/NCT04176302Test |
| وصف الملف: | application/pdf |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::215b66b88cc704f1c696343c08e688cfTest http://hdl.handle.net/10902/24035Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....215b66b88cc704f1c696343c08e688cf |
| قاعدة البيانات: | OpenAIRE |
| الوصف غير متاح. |