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

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/designThis 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 gathe red, 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 wi ll be asked to keep a symptom diary covering the same elements as PD_Manager records. After a minimum of two weeks, each parti...
Source: Trials - Category: Research Source Type: clinical trials