Multimodal Digital Biomarker Prediction of Acute Clinical Deterioration

Rather than relying on a single abnormal vital sign, the study will examine how multiple physiologic signals change together over time and whether changes in the relationships among these signals provide useful information about impending clinical deterioration. Individual participant physiologic patterns may be characterized longitudinally to account for differences between individuals and changes within the same individual over time. The primary objective is to evaluate the predictive accuracy of multimodal digital biomarkers for protocol-defined acute clinical deterioration occurring within 72 hours. The study is observational and does not assign participants to an investigational treatment.

Inclusion Criteria: * Adults aged 18 through 90 years at enrollment. * Able to provide informed consent, or have a legally authorized representative provide consent when permitted by the applicable protocol and regulations. * Able and willing to participate in prospective longitudinal digital biomarker monitoring. * Able to use, or permit application of, study-authorized wearable or remote-monitoring technologies. * Able and willing to provide protocol-specified physiologic, behavioral, acoustic, and symptom data. * Expected to have sufficient follow-up to permit evaluation of the 72-hour prediction endpoint. * Willing to comply with study procedures and data-collection requirements. Exclusion Criteria: * Inability to provide informed consent or otherwise participate through an approved consent process. * Clinical or technical circumstances that prevent reliable collection of the required multimodal digital biomarker data. * Inability or unwillingness to comply with study monitoring procedures. * Enrollment in another study that, in the investigator's judgment, would materially interfere with FUSION-72 data collection or endpoint assessment. * Any circumstance that, in the investigator's judgment, would make participation inappropriate or compromise the integrity of the study.