Acceptability to patients, carers and clinicians of an mHealth platform for the management of Parkinson's disease (PD-Manager): Study protocol for a pilot randomised controlled trial 11 Medical and Health Sciences 1117 Public Health and Health Services

Angelo Antonini, Giovanni Gentile, Manuela Giglio, Andrea Marcante, Heather Gage, Morro M.L. Touray, Dimitrios I. Fotiadis, Dimitris Gatsios, Spyridon Konitsiotis, Lada Timotijevic, Bernadette Egan, Charo Hodgkins, Roberta Biundo, Clelia Pellicano, Harry Hatzakis, Joao Correia, Giglio Manuela, Luca Weis, Margherita Chiarot, Viviana ZaninBarbara Korousic Seljak, Bojan Cestnik, Darko Aleksovski, Dragana Miljkovic, Franc Novak, Marko Bohanec, Tina Anzic, Vid Podpecan, Anita Valmarska, Gregor Papa, Bojan Blazica, Biljana Mileva Boshkoska, Robert Vilzmann, Francesca Assogna, Gianfranco Spalletta, Gaia Romana Pellicano, Valentina Palma, Cristina Scudellari, Tiziana Soru, Mino Napoletano, Francesca Fanciulli, Matteo Raffaelli, Adrian Banks, Brian Elliot, Ellen Seiss, Patrice Rusconi, Matthew Peacock, Sarah Gillies, Elizabeth Puttock, Morro M.L. Touray

Research output: Contribution to journalArticle

Abstract

Background: Parkinson's disease is a degenerative neurological condition causing multiple motor and non-motor symptoms that have a serious adverse effect on quality of life. Management is problematic due to the variable and fluctuating nature of symptoms, often hourly and daily. The PD-Manager mHealth platform aims to provide a continuous feed of data on symptoms to improve clinical understanding of the status of any individual patient and inform care planning. The objectives of this trial are to (1) assess patient (and family carer) perspectives of PD-Manager regarding comfort, acceptability and ease of use; (2) assess clinician views about the utility of the data generated by PD-Manager for clinical decision making and the acceptability of the system in clinical practice. Methods/design: This trial is an unblinded, parallel, two-group, randomised controlled pilot study. A total of 200 persons with Parkinson's disease (Hoehn and Yahr stage 3, experiencing motor fluctuations at least 2 h per day), with primary family carers, in three countries (110 Rome, 50 Venice, Italy; 20 each in Ioannina, Greece and Surrey, England) will be recruited. Following informed consent, baseline information will be gathered, including the following: age, gender, education, attitudes to technology (patient and carer); time since Parkinson's diagnosis, symptom status and comorbidities (patient only). Randomisation will assign participants (1:1 in each country), to PD-Manager vs control, stratifying by age (1 ≤ 70: 1 > 70) and gender (60% M: 40% F). The PD-Manager system captures continuous data on motor symptoms, sleep, activity, speech quality and emotional state using wearable devices (wristband, insoles) and a smartphone (with apps) for storing and transmitting the information. Control group participants will be asked to keep a symptom diary covering the same elements as PD-Manager records. After a minimum of two weeks, each participant will attend a consultation with a specialist doctor for review of the data gathered (by either means), and changes to management will be initiated as indicated. Patients, carers and clinicians will be asked for feedback on the acceptability and utility of the data collection methods. The PD-Manager intervention, compared to a symptom diary, will be evaluated in a cost-consequences framework. Discussion: Information gathered will inform further development of the PD-Manager system and a larger effectiveness trial. Trial registration: ISRCTN Registry, ISRCTN17396879. Registered on 15 March 2017.

Original languageEnglish
Article number492
JournalTrials
Volume19
Issue number1
DOIs
Publication statusPublished - Sep 14 2018

Keywords

  • Acceptability
  • Cost consequence analysis
  • mHealth
  • Parkinson's disease
  • Utility

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

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    Antonini, A., Gentile, G., Giglio, M., Marcante, A., Gage, H., Touray, M. M. L., Fotiadis, D. I., Gatsios, D., Konitsiotis, S., Timotijevic, L., Egan, B., Hodgkins, C., Biundo, R., Pellicano, C., Hatzakis, H., Correia, J., Manuela, G., Weis, L., Chiarot, M., ... Touray, M. M. L. (2018). Acceptability to patients, carers and clinicians of an mHealth platform for the management of Parkinson's disease (PD-Manager): Study protocol for a pilot randomised controlled trial 11 Medical and Health Sciences 1117 Public Health and Health Services. Trials, 19(1), [492]. https://doi.org/10.1186/s13063-018-2767-4