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| ID | Type | Description | Link |
|---|---|---|---|
| 4R44HL172444 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Tidalhealth | UNKNOWN |
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WearME-Pro Patch System + Guided Training | Experimental | Participants with COPD use the WearME-Pro patch system at home and complete scheduled sessions plus daily handheld spirometry. Participants receive guided onboarding/training on device setup, app workflow, and patch placement. Usability, adherence, and agreement between WearME-Pro predicted lung function and reference spirometry are evaluated. WearME-Pro outputs are investigational and not used for clinical decision-making. |
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| WearME-Pro Patch System (Self-Guided / No Training) | Experimental | Participants with COPD use the WearME-Pro patch system at home and complete scheduled sessions plus daily handheld spirometry. Participants follow self-guided instructions without guided training. Usability, adherence, and agreement between WearME-Pro predicted lung function and reference spirometry are evaluated. WearME-Pro outputs are investigational and not used for clinical decision-making. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WearME-Pro Patch System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Months 1-9 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Part A (Baseline/Onboarding through Week 4; up to 1 month) |
| Critical task success rate during Part A (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lloyd E Emokpae, PhD. | Contact | 301-388-5453 | lloyd.emokpae@lasarrus.com | |
| Roland N Emokpae, Jr., MD | Contact | 301-388-8067 | roland.emokpae.jr@lasarrus.com |
| Name | Affiliation | Role |
|---|---|---|
| Edward Chen, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins | Baltimore | Maryland | 21224 | United States |
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| NIH |
Two-component protocol. Part A is a parallel-assignment summative usability study in people with COPD: Training (guided onboarding) vs No-training (self-guided) for ~1 month. Part B is a 10-month longitudinal home-use clinical performance component comparing WearME-Pro predicted lung function to daily handheld spirometry. Participants may enroll in Part A, Part B, or both (Part A first if both).
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| FDA-cleared handheld spirometer (reference comparator) | Device | Daily handheld spirometry collected at home to provide reference standards for paired comparisons with WearME-Pro predicted lung function (FEV1, FVC, FEV1/FVC). |
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| Cardea SOLO ECG patch (optional subset; exploratory HR reference) | Device | 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. |
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Proportion of participants who successfully complete predefined critical tasks during Part A (reported as percent successful). |
| 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. | 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. | 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. | Up to 10 months (during daily sessions through Month 10) |
| LASARRUS Clinic and Research Center Inc. | Baltimore | Maryland | 21230 | United States |
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| TidalHealth | Salisbury | Maryland | 21801 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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