Clinical Utility of Wearable Sensors and Patient-Reported Surveys in Patients With Schizophrenia: Noninterventional, Observational Study.

Background: Relapse in schizophrenia may be preceded by early warning signs of biological, sensory, and clinical status. Early detection of warning signs may facilitate intervention and prevent relapses. Objective: This study aims to investigate the feasibility of using wearable devices and self-reported technologies to identify symptom exacerbation correlates and relapse in patients with schizophrenia. Methods: In this observational study, patients with schizophrenia were provided with remote sensing devices to continuously monitor activity (Garmin vivofit) and sleep (Philips Actiwatch), and smartphones were used to record patient-reported outcomes. Clinical assessments of symptoms (Positive and Negative Syndrome Scale and Brief Psychiatric Rating Scale) were performed biweekly, and other clinical scales on symptoms (Clinical Global Impression-Schizophrenia, Calgary Depression Scale), psychosocial functioning, physical activity (Yale Physical Activity Survey), and sleep (Pittsburgh Sleep Quality Index) were assessed every 4 weeks. Patients were observed for 4 months, and correlations between clinical assessments and aggregated device metrics data were assessed using a mixed-effect model. An elastic net model was used to predict the clinical symptoms based on the device features. Results: Of the 40 patients enrolled, 1 patient relapsed after being stable with evaluable postbaseline data. Weekly patient-reported outcomes were moderately correlated with psychiatric symptoms (Brief Psychiatric Rating Scale total score, r=0.29; Calgary Depression Scale total score, r=0.37; and Positive and Negative Syndrome Scale total score, r=0.3). In the elastic net model, sleep and activity features derived from Philips Actigraph and Garmin vivofit were predictive of the sitting index of the Yale Physical Activity Survey and sleep duration component of the Pittsburgh Sleep Quality Index. On the basis of the combined patient data, a high percentage of data coverage and compliance (>80%) was observed for each device. Conclusions: This study demonstrated that wearable devices and smartphones could be effectively deployed and potentially used to monitor patients with schizophrenia. Furthermore, metrics-based prediction models can assist in detecting earlier signs of symptom changes. The operational learnings from this study may provide insights to conduct future studies. Trial Registration: ClinicalTrials.gov NCT02224430; https://www.clinicaltrials.gov/ct2/show/NCT02224430