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.
WearME-Pro is a wearable, non-invasive physiological monitoring platform with two identical sensor modules, a patient-facing mobile application, and an optional clinician dashboard. For longitudinal use, the sensor modules are inserted into an adhesive patch retainer intended for prolonged skin contact (target up to \~28 days continuous wear per retainer; patch replacement per IFU/study procedures). The patch remains on the skin continuously between scheduled sessions; the mobile app initiates daily recording windows (typically totaling \~30-180 minutes/day), and sensors remain in low-power mode outside those windows. In the longitudinal component, participants complete daily WearME-Pro sessions plus daily handheld spirometry to enable paired comparisons. A subset of participants may optionally wear an FDA-cleared ECG patch (Cardea SOLO) for 24-48 hours at Baseline and End of Study as an exploratory heart-rate reference. Participants also complete daily symptom reporting and periodic questionnaires, with check-ins per the protocol schedule.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
82
Wearable non-invasive monitoring platform with two sensor modules, mobile app, and optional clinician dashboard; patch retainer supports continuous wear up to \~28 days per retainer; scheduled daily recording windows typically \~30-180 min/day.
Daily handheld spirometry collected at home to provide reference standards for paired comparisons with WearME-Pro predicted lung function (FEV1, FVC, FEV1/FVC).
Optional FDA-cleared single-use ECG patch worn up to 24-48 hours at Baseline and End of Study for exploratory heart-rate reference comparisons.
Johns Hopkins
Baltimore, Maryland, United States
LASARRUS Clinic and Research Center Inc.
Baltimore, Maryland, United States
TidalHealth
Salisbury, Maryland, United States
Mean difference in FEV1 (L) between WearME-Pro predicted lung function and handheld spirometer
Agreement will be assessed using paired daily measurements of FEV1 collected during home use. The outcome will be summarized as the mean difference (WearME-Pro - handheld spirometer) in FEV1 (liters) across paired measurements.
Time frame: Up to 10 months (daily paired measures through Month 10)
Mean difference in FVC (L) between WearME-Pro predicted lung function and handheld spirometer
Agreement will be assessed using paired daily measurements of FVC collected during home use. The outcome will be summarized as the mean difference (WearME-Pro - handheld spirometer) in FVC (liters) across paired measurements.
Time frame: 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
Agreement will be assessed using paired daily measurements of FEV1/FVC collected during home use. The outcome will be summarized as the mean difference (WearME-Pro - handheld spirometer) in FEV1/FVC ratio across paired measurements.
Time frame: Up to 10 months (daily paired measures through Month 10)
System Usability Scale (SUS) total score (0-100)
SUS questionnaire to assess usability for intended users in Part A (human factors/usability). Target mean SUS \> 85 over the usability period.
Time frame: End of Part A (Week 4; up to 1 month)
Monthly adherence rate to planned daily WearME-Pro sessions (%)
Adherence will be summarized as the percent of planned days per month with a completed WearME-Pro session with valid data, with a target of ≥85% monthly adherence during the longitudinal component.
Time frame: Months 1-9
Single Ease Question (SEQ) score (7-point Likert scale)
SEQ ratings collected during Part A to assess perceived ease of use for critical tasks (higher score indicates easier).
Time frame: Part A (Baseline/Onboarding through Week 4; up to 1 month)
Critical task success rate during Part A (%)
Proportion of participants who successfully complete predefined critical tasks during Part A (reported as percent successful).
Time frame: Part A (Baseline/Onboarding through Week 4; up to 1 month)
Number of use errors during critical tasks in Part A
Count of observed use errors during predefined critical tasks performed in Part A.
Time frame: Part A (Baseline/Onboarding through Week 4; up to 1 month)
Mean difference in heart rate (bpm) between WearME-Pro and Cardea SOLO ECG patch
Heart rate agreement will be summarized as the mean difference (WearME-Pro - Cardea SOLO) in beats per minute (bpm) during the monitoring windows in the optional subset.
Time frame: Up to 48 hours at Baseline and up to 48 hours at End of Study (Month 10)
Respiratory rate (breaths per minute) measured by WearME-Pro
Respiratory rate measured by WearME-Pro during daily home-use sessions; summarized as the mean respiratory rate (breaths/min) during each session, and averaged across sessions through Month 10.
Time frame: Up to 10 months (during daily sessions through Month 10)
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