‘Carer-as-Sensor’ in Decentralized Trials: Passive Sensing Data Accuracy, Parkinson’s, and Observers (Preprint)

BACKGROUND Parkinson's clinical trials depend on patient-reported outcomes, often overlooking the vital role of carers in collaboratively tracking symptom progression. This is a potential limitation for decentralized clinical trials aimed at measuring real-world, free-living symptoms with sensors, such as wearables and cameras in the home. OBJECTIVE The primary objective of our study was to inform the design of a multimodal sensor platform for decentralised clinical trials. METHODS A qualitative study was conducted with an inductive approach using semistructured interviews with a cohort of people with Parkinson's. RESULTS This study of 18 participants (14 people diagnosed with Parkinsons, 4 spouses/informal carers) found that carers, household members, and peers take a central role in helping people with Parkinson’s make sense of and manage their symptoms. Our participants relied on others to help with completing tasks and understanding their symptoms through comparison to others, using their Carer-as-Sensor. While our participants mostly viewed their relationships with others positively, this could lead to negative impacts on oneself. Participants could prioritize household needs over their health by not taking medication or risking a chance of falling, or even avoiding being around others to prevent their Parkinson's being on display to reduce carer burden. CONCLUSIONS Our results argue that an 'outsider' and 'insider' approach to reporting symptoms can identify symptoms that are not noticed by people with Parkinson's, or withheld from carers. These form household-centred recommendations more broadly for the design of tracking and annotation strategies in the context of decentralised clinical trials and new innovations in AI to support the capture of nuanced and subtle changes in symptoms.