Background: Mobile health, predominantly wearable technology and mobile apps, have been considered in Parkinson disease to provide valuable ecological data between face-to-face visits and improve monitoring of motor symptoms remotely.
Objective: We explored the feasibility of using a technology-based mHealth platform comprising a smartphone in combination with a smartwatch and a pair of smart insoles, described in this study as the PD_manager system, to collect clinically meaningful data. We also explored outcomes and disease-related factors that are important determinants to establish feasibility. Finally, we further validated a tremor evaluation method with data collected while patients performed their daily activities.
Methods: PD_manager trial was an open-label parallel group randomized study.The mHealth platform consists of a wristband, a pair of sensor insoles, a smartphone (with dedicated mobile Android apps) and a knowledge platform serving as the cloud backend. Compliance was assessed with statistical analysis and the factors affecting it using appropriate regression analysis. The correlation of the scores of our previous algorithm for tremor evaluation and the respective Unified Parkinson's Disease Rating Scale estimations by clinicians were explored.
Results: Of the 75 study participants, 65 (87%) completed the protocol. They used the PD_manager system for a median 11.57 (SD 3.15) days. Regression analysis suggests that the main factor associated with high use was caregivers' burden. Motor Aspects of Experiences of Daily Living and patients' self-rated health status also influence the system's use. Our algorithm provided clinically meaningful data for the detection and evaluation of tremor.
Conclusions: We found that PD patients, regardless of their demographics and disease characteristics, used the system for 11 to 14 days. The study further supports that mHealth can be an effective tool for the ecologically valid, passive, unobtrusive monitoring and evaluation of symptoms. Future studies will be required to demonstrate that an mHealth platform can improve disease management and care.
Trial registration: ISRCTN Registry ISRCTN17396879; http://www.isrctn.com/ISRCTN17396879.
International registered report identifier (irrid): RR2-10.1186/s13063-018-2767-4.
Keywords: Parkinson's disease; clinically meaningful data; determinants of compliance; ecological validity.
©Dimitris Gatsios, Angelo Antonini, Giovanni Gentile, Andrea Marcante, Clelia Pellicano, Lucia Macchiusi, Francesca Assogna, Gianfranco Spalletta, Heather Gage, Morro Touray, Lada Timotijevic, Charo Hodgkins, Maria Chondrogiorgi, George Rigas, Dimitrios I Fotiadis, Spyridon Konitsiotis. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 29.06.2020.