Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
COPD, Wearable sensor, WearME, Remote monitoring, Home use, Lung function, Spirometry, FEV1, FVC, FEV1/FVC, Usability, Human factors, Adherence, Mobile application, Patch
Brief 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.
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.
Interventions
DEVICEWearME-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.
DEVICEFDA-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).
DEVICECardea 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.
Sponsors
LASARRUS Clinic and Research Center
Johns Hopkins University
Tidalhealth
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean difference in FEV1 (L) between WearME-Pro predicted lung function and handheld spirometer | Up to 10 months (daily paired measures through Month 10) | 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. |
| Mean difference in FVC (L) between WearME-Pro predicted lung function and handheld spirometer | Up to 10 months (daily paired measures through Month 10) | 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. |
| Mean difference in FEV1/FVC (unitless ratio) between WearME-Pro predicted lung function and handheld spirometry | Up to 10 months (daily paired measures through Month 10) | 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. |
| System Usability Scale (SUS) total score (0-100) | End of Part A (Week 4; up to 1 month) | SUS questionnaire to assess usability for intended users in Part A (human factors/usability). Target mean SUS \> 85 over the usability period. |
| Monthly adherence rate to planned daily WearME-Pro sessions (%) | Months 1-9 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single Ease Question (SEQ) score (7-point Likert scale) | Part A (Baseline/Onboarding through Week 4; up to 1 month) | SEQ ratings collected during Part A to assess perceived ease of use for critical tasks (higher score indicates easier). |
| Critical task success rate during Part A (%) | Part A (Baseline/Onboarding through Week 4; up to 1 month) | Proportion of participants who successfully complete predefined critical tasks during Part A (reported as percent successful). |
| Number of use errors during critical tasks in Part A | Part A (Baseline/Onboarding through Week 4; up to 1 month) | Count of observed use errors during predefined critical tasks performed in Part A. |
| Mean difference in heart rate (bpm) between WearME-Pro and Cardea SOLO ECG patch | Up to 48 hours at Baseline and up to 48 hours at End of Study (Month 10) | 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. |
| Respiratory rate (breaths per minute) measured by WearME-Pro | Up to 10 months (during daily sessions through Month 10) | 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. |
Countries
United States
Contacts
CONTACTLloyd E Emokpae, PhD.
CONTACTRoland N Emokpae, Jr., MD
PRINCIPAL_INVESTIGATOREdward Chen, MD
Johns Hopkins University
Outcome results
None listed