WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor). (WearME-Pro)

WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Device: WearME-Pro Patch System; Device: FDA-cleared handheld spirometer (reference comparator); Device: Cardea SOLO ECG patch (optional subset; exploratory HR reference)

Detailed Description

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
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lloyd E Emokpae, PhD.; Phone Number: 301-388-5453; Email: lloyd.emokpae@lasarrus.com
• Study Contact Backup: Name: Roland N Emokpae, Jr., MD; Phone Number: 301-388-8067; Email: roland.emokpae.jr@lasarrus.com

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins
      • Contact: Edward S Chen, MD; Phone Number: (410) 550-5864; Email: echen3@jh.edu
      • Contact: Tianzhi Mao; Phone Number: (410)502-5819; Email: tmao2@jhmi.edu
      • Sub-Investigator: Adrian S Dobs, MD
    • Baltimore, Maryland, United States, 21230
      • LASARRUS Clinic and Research Center Inc.
      • Contact: Roland N Emokpae, Jr., MD; Phone Number: 301-388-8067; Email: roland.emokpae.jr@lasarrus.com
      • Contact: Lloyd Emokpae, PhD; Phone Number: 301-388-5453; Email: lloyd.emokpae@lasarrus.com
      • Sub-Investigator: Lia Mandavalli, DO
    • Salisbury, Maryland, United States, 21801
      • Tidalhealth
      • Contact: Robert T Chasse, MD; Phone Number: 410-543-7722; Email: Robert.Chasse@tidalhealth.org
      • Contact: Robert Joyner, PhD., RRT; Phone Number: 410-543-7017; Email: Robert.Joyner@tidalhealth.org
      • Sub-Investigator: Sandra Fetko

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 21 years or older, either sex.
• Diagnosed with COPD per GOLD criteria (GOLD 2025): post-bronchodilator FEV1/FVC < 0.70; stratified by post-bronchodilator FEV1% predicted (severity strata).
• On stable maintenance therapy for at least 2 months (no COPD medication class changes or dose escalations).
• Current, former, or never smoker (smoking history collected but not an eligibility requirement).
• Able to perform activities of daily living and complete study procedures (e.g., sit upright and perform spirometry maneuvers).
• Able and willing to provide informed consent.
• Not currently enrolled in another investigational device study that could confound outcomes (prior WearME-Basic Phase I participation permitted if completed and not concurrent).
• Owns a compatible smartphone/tablet or willing to use a loaner device.
• Willing to wear WearME-Pro patch and perform daily handheld spirometry throughout the study.
• Optional subset only: willing to wear Cardea SOLO ECG patch for up to 24-48 hours at baseline and end of study if selected.

Exclusion Criteria:

• COPD exacerbation within past 6 weeks requiring systemic corticosteroids and/or antibiotics, urgent/ED visit, or hospitalization.
• Known allergy or severe skin sensitivity to medical adhesives, or dermatologic conditions at intended placement sites.
• Any condition that, in the investigator's opinion, may interfere with compliance or safety.
• Inability or unwillingness to perform daily spirometry or to use the mobile app.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WearME-Pro Patch System + Guided Training; 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.	Device: WearME-Pro Patch System; 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.; Device: FDA-cleared handheld spirometer (reference comparator); Daily handheld spirometry collected at home to provide reference standards for paired comparisons with WearME-Pro predicted lung function (FEV1, FVC, FEV1/FVC).; Device: Cardea SOLO ECG patch (optional subset; exploratory HR reference); 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.
Experimental: WearME-Pro Patch System (Self-Guided / No Training); 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.	Device: WearME-Pro Patch System; 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.; Device: FDA-cleared handheld spirometer (reference comparator); Daily handheld spirometry collected at home to provide reference standards for paired comparisons with WearME-Pro predicted lung function (FEV1, FVC, FEV1/FVC).; Device: Cardea SOLO ECG patch (optional subset; exploratory HR reference); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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 (%)	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)

Collaborators and Investigators

• Sponsor: LASARRUS Clinic and Research Center
• Collaborators: Johns Hopkins University; National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH); TidalHealth
• Investigators: Principal Investigator: Edward Chen, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 28, 2028
• Study Completion (Estimated): April 28, 2028

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Adherence; COPD; Lung function; Remote monitoring; Spirometry; Wearable sensor; Usability; FEV1; Mobile application; FVC; Human factors; Home use; Patch; FEV1/FVC; WearME
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: LAS-02/03-WZ-024; 4R44HL172444 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No