This Phase II investigation evaluates the safety, usability, and clinical performance of the WearME-Pro patch system for remote monitoring of adults with COPD in a home-use environment. The protocol includes two components: (A) a \~1-month summative usability/human factors evaluation of the WearME-Pro patch, mobile app, and clinician dashboard; and (B) a 10-month longitudinal home-use study comparing WearME-Pro predicted lung function metrics (FEV1, FVC, FEV1/FVC) to an FDA-cleared handheld spirometer, with an adherence target of ≥85%. WearME-Pro outputs are investigational and are not used to direct clinical decisions during the study.
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Mean difference in FEV1 (L) between WearME-Pro predicted lung function and handheld spirometer
Timeframe: Up to 10 months (daily paired measures through Month 10)
Mean difference in FVC (L) between WearME-Pro predicted lung function and handheld spirometer
Timeframe: Up to 10 months (daily paired measures through Month 10)
Mean difference in FEV1/FVC (unitless ratio) between WearME-Pro predicted lung function and handheld spirometry
Timeframe: Up to 10 months (daily paired measures through Month 10)
System Usability Scale (SUS) total score (0-100)
Timeframe: End of Part A (Week 4; up to 1 month)
Monthly adherence rate to planned daily WearME-Pro sessions (%)
Timeframe: Months 1-9