The Impact of a Digital Artificial Intelligence System on the Monitoring and Self-management of Nonmotor Symptoms in People With Parkinson Disease: Proposal for a Phase 1 Implementation Study

Abstract

Background Nonmotor symptoms of Parkinson disease are a major factor of disease burden but are often underreported in clinical appointments. A digital tool has been developed to support the monitoring and management of nonmotor symptoms. Objective The aim of this study is to establish evidence of the impact of the system on patient confidence, knowledge, and skills for self-management of nonmotor symptoms, symptom burden, and quality of life of people with Parkinson and their care partners. It will also evaluate the usability, acceptability, and potential for adoption of the system for people with Parkinson, care partners, and health care professionals. Methods A mixed methods implementation and feasibility study based on the nonadoption, abandonment, scale-up, spread, and sustainability framework will be conducted with 60 person with Parkinson–care partner dyads and their associated health care professionals. Participants will be recruited from outpatient clinics at the University Hospitals Plymouth NHS Trust Parkinson service. The primary outcome, patient activation, will be measured over the 12-month intervention period; secondary outcomes include the system’s impact on health and well-being outcomes, safety, usability, acceptability, engagement, and costs. Semistructured interviews with a subset of participants will gather a more in-depth understanding of user perspectives and experiences with the system. Repeated measures analysis of variance will analyze change over time and thematic analysis will be conducted on qualitative data. The study was peer reviewed by the Parkinson’s UK Non-Drug Approaches grant board and is pending ethical approval. Results The study won funding in August 2021; data collection is expected to begin in December 2022. Conclusions The study’s success criteria will be affirming evidence regarding the system’s feasibility, usability and acceptability, no serious safety risks identified, and an observed positive impact on patient activation. Results will be disseminated in academic peer-reviewed journals and in platforms and formats that are accessible to the general public, guided by patient and public collaborators. Trial Registration ClinicalTrials.gov NCT05414071; https://clinicaltrials.gov/ct2/show/NCT05414071 International Registered Report Identifier (IRRID) PRR1-10.2196/40317