Article Text

Protocol
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
  1. Alejandro Rodríguez-Molinero1,
  2. Jorge Hernández-Vara2,
  3. Antonio Miñarro3,
  4. Carlos Pérez-López1,
  5. Àngels Bayes-Rusiñol4,
  6. Juan Carlos Martínez-Castrillo5,
  7. David A Pérez-Martínez6
  8. Monitoring Parkinson’s patients Mobility for therapeutic purposes research group
    1. 1Àrea de Recerca, Consorci Sanitari de l"Alt Penedès i Garraf, Vilafranca del Pendès, Spain
    2. 2Department of Neurology, Hospital Universitari Vall d"Hebron and Neurodegenerative Diseases Research Group, Barcelona, Spain
    3. 3Department of Genetics, Microbiology and Statistics, Faculty of Biology, Universitat de Barcelona, Barcelona, Spain
    4. 4Parkinson"s and Movement Disorders Unit, Hospital Quirón Teknon, Barcelona, Spain
    5. 5Movement Disorders and Neurodegenerative Diseases Unit, Hospital Ramón y Cajal, Madrid, Spain
    6. 6Neurology Service, Hospital Universitario 12 de Octubre, Madrid, Spain
    1. Correspondence to Dr Alejandro Rodríguez-Molinero; rodriguez.molinero{at}gmail.com

    Abstract

    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.

    • Parkinson"s disease
    • neurology
    • clinical trials

    Data availability statement

    Data sharing not applicable as no datasets generated and/or analysed for this study.

    http://creativecommons.org/licenses/by-nc/4.0/

    This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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    Data availability statement

    Data sharing not applicable as no datasets generated and/or analysed for this study.

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    Supplementary materials

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    Footnotes

    • Collaborators This research is being conducted by the "Monitoring Parkinson’s patients Mobility for therapeutic purposes" (MoMoPa) research group, which includes, in addition to the authors of this papers: Hospital de Sant Joan Despí Moisès Broggi (Nuria Caballol Pons, Anna Planas-Ballvé), Hospital Universitari Mútua Terrassa (Mariateresa Buongiorno, Pau Pastor, Ignacio Alvarez), Hospital Universitario de Toledo (Núria López Ariztegui, Mª Isabel Morales Casado), Hospital Universitario Ramón y Cajal (Gema Sánchez), Hospital General de l"Hospitalet (María Asunción Ávila Rivera), Terapia Integral Uparkinson (Anna Prats), Hospital General Universitario de Elche (María Álvarez Saúco), Hospital de la Santa Creu i Sant Pau (Alexandre Gironell Carreró), Hospital Universitario 12 de Octubre (Álvaro Sánchez-Ferro, Antonio Méndez Guerrero), Hospital Sant Camil (Elisabet Franquet Gomez), Hospital de Tortosa Verge de la Cinta (Sonia Escalante Arroyo), Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla (Laura Muñoz-Delgado, Daniel Macías-García, Silvia Jesús, Astrid Adarmes-Gómez, Pablo Mir), Hospital Clínico de Valencia (José Mª Salom Juan, Antonio Salvador Aliaga), Hospital General de Alicante (Silvia Martí Martínez, Carlos Leiva Santana), Hospital del Mar (Victor M. Puente Pérez, Irene Navalpotro Gómez), Hospital Vall d"Hebron (Sara Lucas del Pozo), Hospital Universitario Fundación Alcorcón (Lydia Vela Desojo), Hospital Álvaro Cunqueiro (Antonio Koukoulis Fernández, Mª Gema Alonso Losada), Hospital Universitario de Burgos (Mª Esther Cubo Delgado), Hospital Universitario Marqués de Valdecilla (Jon Infante Ceberío, María Sierra Peña, Isabel González Aramburu, Mª Victoria Sánchez Peláez), Hospital Universitario Infanta Sofía (Marina Mata Álvarez-Santullano, Carmen Borrúe Fernández, Mª Concepción Jimeno Montero), Clínico Virgen de la Victoria (Mª José Gómez Heredia, Francisco Pérez Errazquin, Lina Carazo Barrios), Hospital Royo Villanova (Alfredo López López), Hospital de Llíria (Mª Pilar Solís Pérez), Hospital Univ Lucus Augusti (Rubén Alonso Redondo, Jessica González Ardura), Hospital Universitario Donostia (Javier Ruiz Martínez, Ana Vinagre Aragón, Ioana Croitoru), Hospital Universitario Puerta de Hierro Majadahonda (Pilar Sánchez Alonso, Elisa Gamo Gonzalez, Sabela Novo Ponte), Hospital Moraleja (Esteban Peña Llamas), Hospital Alcázar de San Juan (Esther Blanco Vicente, Rafael García Ruiz, Ana Rita Santos Pinto, Marta Recio-Bermejo), Hospital Virgen de la Arrixaca de Murcia (José López Sánchez, Judith Jiménez Veiga), Hospital Regional de Málaga (Teresa Muñoz Ruiz, Lucía Flores García), Hospital Clínico San Carlos (Rocío García-Ramos, Eva López Valdés), Hospital German Trias i Pujol (Lourdes Ispierto González, Ramiro Álvarez Ramo, Dolores Vilas Rolan), Hospital Comarcal de l"Alt Penedès (Esther Catena Ruiz), Hospital Universitari General de Catalunya (Ernest Balaguer, Antonio Hernández Vidal), Hospital Universitari de Girona Doctor Josep Trueta (Berta Solano Vila, Anna Cots Foraster, Daniel López Domínguez), Hospital la Princesa (Lydia López‐Manzanares)

    • Contributors AR-M conceived and designed the study, and drafted this paper. JH-V, AB, JCM-C and DADAP-M contributed to the study design. CP-L contributed to study logistics preparation, including software for managing Parkinson’s Holter data during the trial. AM contributed to the statistical analysis plan. All authors have read and approved the manuscript.

    • Funding This work is supported by AbbVie S.L.U, the Instituto de Salud Carlos III [DTS17/00195] and the European Fund for Regional Development, "A way to make Europe".

    • Competing interests AR-M and CP-L are shareholders of Sense4Care, the company that will market the tested device in the short term. AR-M participated with other authors in obtaining funding for the study and in the protocol design. Given his conflict of interest, he will manage the project as the sponsoring centre’s coordinator but will not participate in the data collection, study monitoring, statistical analysis or interpretation of results. CP-L only contributed to study logistics preparation, including software for managing Parkinson’s Holter data during the trial.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.