Wearable Devices in the Recovery Phase of Acute Exacerbations of COPD (AECOPDs)

Study Overview
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Brief Summary
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The purpose the study is to successfully characterize the recovery phase of acute exacerbations of COPD in the outpatient setting using remotely captured physiologic data from wearable devices, to compare this with patient self-reported symptom data, to determine which physiologic variable(s) best correspond with AECOPD recovery, and to further document the feasibility, data quantity, data quality, and COPD outpatient usability experience with wearable devices.

Official Title
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Characterizing the Recovery Phase of Acute Exacerbations of COPD Using Wearable Remote Monitoring Technology

Conditions
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Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Exacerbation

Intervention / Treatment
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* Device: Biometric wearable devices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males/females, age ≥40, former/current smokers with ≥10 pack-year smoking history Currently experiencing/receiving treatment for a physician-diagnosed AECOPD Forced expired volume in the first second (FEV1) / Forced vital capacity (FVC) < 0.7 (GOLD 1-4) Ability to provide informed consent Exclusion Criteria: No existing COPD diagnosis History of cardiac arrhythmia Presence of pacemaker/defibrillator Any medical/cognitive/functional condition which renders inability to don/doff/recharge devices and complete symptom questionnaire Have already received 4 or more days of consecutive corticosteroid and/or antibiotic therapy since presenting to medical attention for their AECOPD

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD cohort<br>Patients with COPD currently experiencing and receiving treatment for an exacerbation. | Device: Biometric wearable devices<br>* Passive data collection using biometric wearable devices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily symptom score | Validated AECOPD symptom score (EXACT PRO) will serve as the dependent (outcome) variable. | Daily for 21 days | 
| Daily/nightly respiration | Respiratory rate (RR) will serve as the primary independent (predictor) variable, and RR variability will serve as a secondary independent (predictor) variable. | Daily for 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily/nightly heart rate and HR variability | HR and HRV will serve as secondary independent (predictor) variables. | Daily for 21 days | 
| Daily/nightly peripheral body temperature | Temperature will serve as secondary independent (predictor) variables. | Daily for 21 days | 
| Activity | Activity parameters (including calories, METS, step count, etc.) will serve as secondary independent (predictor) variables. | Daily for 21 days | 
| Sleep metrics | Sleep metrics (including rem and non-rem stages of sleep; sleep duration, latency, efficiency, etc.) will serve as secondary independent (predictor) variables. | Daily (nightly) for 21 days. | 
| Autonomic function/Stress | Metrics of stress/autonomic function (including electrodermal activity) will serve as secondary independent (predictor) variables. | Daily for 21 days |