Multimodal Digital Biomarker Prediction of Acute Clinical Deterioration

Condition(s) studied

Investigational drug(s) / intervention(s)

Multimodal Digital Biomarker Monitoring: Prospective collection and analysis of multimodal digital biomarkers derived from wearable and remote-monitoring technologies, including ECG, PPG, oxygen saturation, temperature, gait, sleep, voice, cough, and participant-reported symptom data. The monitoring is observational and does not direct or replace clinical care, does not assign treatment, and does not require modification of participants' usual medical management. Multimodal signals will be temporally aligned and evaluated for changes in inter-signal relationships associated with protocol-defined clinical deterioration occurring within the subsequent 72-hour prediction window.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Predictive Accuracy of Multimodal Digital Biomarker Fusion for Acute Clinical Deterioration Within 72 Hours — At initiation of each prespecified prediction episode and 72 hours after initiation of each prespecified prediction episode.
  Performance of the prespecified multimodal digital biomarker model in predicting protocol-defined acute clinical deterioration during the subsequent 72-hour prediction window. Model performance will be evaluated using the area under the receiver operating characteristic curve (AUROC), with additional assessment of the area under the precision-recall curve (AUPRC), sensitivity, specificity, positive predictive value, negative predictive value, and calibration.

Trial sites (1)

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