title: Large-Scale Wearable Sensor Deployment in Parkinson's Patients: The Parkinson@Home Study Protocol.
abstract: BACKGROUND
  Long-term management of Parkinson's disease does not reach its full potential because we lack knowledge about individual variations in clinical presentation and disease progression. Continuous and longitudinal assessments in real-life (ie, within the patients' own home environment) might fill this knowledge gap.
  
  
  OBJECTIVE
  The primary aim of the Parkinson@Home study is to evaluate the feasibility and compliance of using multiple wearable sensors to collect clinically relevant data. Our second aim is to address the usability of these data for answering clinical research questions. Finally, we aim to build a database for future validation of novel algorithms applied to sensor-derived data from Parkinson's patients during daily functioning.
  
  
  METHODS
  The Parkinson@Home study is a two-phase observational study involving 1000 Parkinson's patients and 250 physiotherapists. Disease status is assessed using a short version of the Parkinson's Progression Markers Initiative protocol, performed by certified physiotherapists. Additionally, participants will wear a set of sensors (smartwatch, smartphone, and fall detector), and use these together with a customized smartphone app (Fox Insight), 24/7 for 3 months. The sensors embedded within the smartwatch and fall detector may be used to estimate physical activity, tremor, sleep quality, and falls. Medication intake and fall incidents will be measured via patients' self-reports in the smartphone app. Phase one will address the feasibility of the study protocol. In phase two, mathematicians will distill relevant summary statistics from the raw sensor signals, which will be compared against the clinical outcomes.
  
  
  RESULTS
  Recruitment of 300 participants for phase one was concluded in March, 2016, and the follow-up period will end in June, 2016. Phase two will include the remaining participants, and will commence in September, 2016.
  
  
  CONCLUSIONS
  The Parkinson@Home study is expected to generate new insights into the feasibility of integrating self-collected information from wearable sensors into both daily routines and clinical practices for Parkinson's patients. This study represents an important step towards building a reliable system that translates and integrates real-life information into clinical decisions, with the long-term aim of delivering personalized disease management support.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02474329; https://clinicaltrials.gov/ct2/show/NCT02474329 (Archived at http://www.webcitation.org/6joEc5P1v).
authors: Donders Institute for Brain, Cognition and Behavior, Radboud university medical center, Nijmegen, Netherlands. ana.silvadelima@radboudumc.nl.
authors: Ana Lígia
authors: http://orcid.org/0000-0002-0948-9290
authors: AL
authors: Silva de Lima
authors: Tim
authors: http://orcid.org/0000-0001-8349-260X
authors: T
authors: Hahn
authors: Nienke M
authors: http://orcid.org/0000-0002-1972-2703
authors: NM
authors: de Vries
authors: Eli
authors: http://orcid.org/0000-0002-9297-4368
authors: E
authors: Cohen
authors: Lauren
authors: http://orcid.org/0000-0002-8736-9155
authors: L
authors: Bataille
authors: Max A
authors: http://orcid.org/0000-0002-1507-3822
authors: MA
authors: Little
authors: Heribert
authors: http://orcid.org/0000-0001-6556-4657
authors: H
authors: Baldus
authors: Bastiaan R
authors: http://orcid.org/0000-0002-6371-3337
authors: BR
authors: Bloem
authors: Marjan J
authors: http://orcid.org/0000-0001-6491-7035
authors: MJ
authors: Faber
keywords: Parkinson’s disease; ambulatory monitoring; computer-assisted; signal processing; wearable sensors