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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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).
• Устройство 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.

Первичные конечные точки

• Mean difference in FEV1 (L) between WearME-Pro predicted lung function and handheld spirometer [Срок оценки: Up to 10 months (daily paired measures through Month 10)]
• Mean difference in FVC (L) between WearME-Pro predicted lung function and handheld spirometer [Срок оценки: 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 [Срок оценки: Up to 10 months (daily paired measures through Month 10)]
• System Usability Scale (SUS) total score (0-100) [Срок оценки: End of Part A (Week 4; up to 1 month)]
• Monthly adherence rate to planned daily WearME-Pro sessions (%) [Срок оценки: Months 1-9]

Вторичные конечные точки (5)

• Single Ease Question (SEQ) score (7-point Likert scale) [Срок оценки: Part A (Baseline/Onboarding through Week 4; up to 1 month)]
• Critical task success rate during Part A (%) [Срок оценки: Part A (Baseline/Onboarding through Week 4; up to 1 month)]
• Number of use errors during critical tasks in Part A [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Up to 10 months (during daily sessions through Month 10)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 3 центра

• Johns Hopkins — Baltimore
• LASARRUS Clinic and Research Center Inc. — Baltimore
• TidalHealth — Salisbury

Идентификаторы

NCT: NCT07430605 · LAS-02/03-WZ-024 · 4R44HL172444

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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