WearME-Pro Patch for COPD

(WearME-Pro Trial)

Not yet recruiting at 2 trial locations

Overseen By Roland N Emokpae, Jr., MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: LASARRUS Clinic and Research Center

Must be taking: COPD maintenance therapy

Disqualifiers: COPD exacerbation, Allergy to adhesives, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Edward Chen, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Inclusion Criteria

Current, former, or never smoker (smoking history collected but not an eligibility requirement)

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)

Exclusion Criteria

Any condition that, in the investigator's opinion, may interfere with compliance or safety

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usability Evaluation

Summative usability/human factors evaluation of the WearME-Pro patch, mobile app, and clinician dashboard

4 weeks

Baseline/Onboarding through Week 4

Longitudinal Home-Use Study

Participants use the WearME-Pro patch system for daily monitoring and comparison with handheld spirometry

10 months

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• WearME-Pro Patch System

How Is the Trial Designed?

Group I: WearME-Pro Patch System + Guided Training Experimental Treatment 3 Interventions

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.

Group II: WearME-Pro Patch System (Self-Guided / No Training) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

LASARRUS Clinic and Research Center

Lead Sponsor

Trials

1

Recruited

130+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Tidalhealth

Collaborator

Trials

1

Recruited

130+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+