1. 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
- Author
-
Antonini, A1, 2, Gentile, G2, Giglio, M2, Marcante, A1, Gage, H3, Touray, Mml4, Fotiadis, Di5, Gatsios, D5, Konitsiotis, S6, Timotijevic, L7, Egan, B7, Hodgkins, C7, Biundo, R2, Pellicano, C, Hatzakis, H, Correia Jesuino, Jorge, Antonini, A, Marcante, A, Biundo, R, Gentile, G, Manuela, G, Weis, L, Chiarot, M, Zanin, V, Seljak, Bk, Cestnik, B, Aleksovski, D, Miljkovic, D, Novak, F, Bohanec, M, Anzic, T, Podpecan, V, Valmarska, A, Papa, G, Blazica, B, Boshkoska, Bm, Vilzmann, R, Assogna, F, Spalletta, G, Pellicano, Gr, Palma, V, Scudellari, C, Soru, T, Napoletano, ANTONELLO MARIO, Fanciulli, F, Raffaelli, M, Banks, THOMAS ALLEN, Elliot, B, Hodgkins, C, Seiss, E, Gage, H, Timotijevic, L, Egan, B, Rusconi, P, Peacock, M, Gillies, S, Puttock, E, Touray, Mml, Gatsios, D, Rigas, G, Fotiadis, D, VON FALKENHAUSEN, VERA CHARLOTTE, Uceda, J, Mascato, Sv, de la Cal JR, Olmedo, Jjs, Martinez, F, Arrendondo, Mt, Cikajlo, I, and Peterlin-Potisk, K.
- Subjects
Male ,Health Knowledge, Attitudes, Practice ,Medicine (miscellaneous) ,Pilot Projects ,Disease ,law.invention ,Study Protocol ,0302 clinical medicine ,Acceptability ,Randomized controlled trial ,Utility ,Informed consent ,law ,Multicenter Studies as Topic ,Pharmacology (medical) ,030212 general & internal medicine ,mHealth ,Randomized Controlled Trials as Topic ,lcsh:R5-920 ,Delivery of Health Care, Integrated ,Parkinson Disease ,Telemedicine ,3. Good health ,Europe ,Treatment Outcome ,Caregivers ,Female ,lcsh:Medicine (General) ,medicine.medical_specialty ,Attitude of Health Personnel ,Clinical Decision-Making ,Control (management) ,acceptability ,cost consequence analysis ,Parkinson’s disease ,utility ,03 medical and health sciences ,Quality of life (healthcare) ,Physicians ,Intervention (counseling) ,medicine ,Humans ,Aged ,Patient Care Team ,Data collection ,business.industry ,Patient Acceptance of Health Care ,Physical therapy ,Cost consequence analysis ,business ,030217 neurology & neurosurgery - 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. Electronic supplementary material The online version of this article (10.1186/s13063-018-2767-4) contains supplementary material, which is available to authorized users.
- Published
- 2018