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.

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