WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor). (NCT07430605) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor).
United States82 participantsStarted 2026-05-01
Plain-language summary
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 can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 spirome…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
2
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)
3
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)
4
System Usability Scale (SUS) total score (0-100)
Timeframe: End of Part A (Week 4; up to 1 month)
5
Monthly adherence rate to planned daily WearME-Pro sessions (%)