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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Chronic Obstructive Pulmonary Disease Exacerbation
• Intervention / Treatment: Device: Biometric wearable devices

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD currently experiencing an exacerbation.

Description

Inclusion Criteria:

1. Males/females, age ≥40, former/current smokers with ≥10 pack-year smoking history
2. Currently experiencing/receiving treatment for a physician-diagnosed AECOPD
3. Forced expired volume in the first second (FEV1) / Forced vital capacity (FVC) < 0.7 (GOLD 1-4)
4. Ability to provide informed consent

Exclusion Criteria:

1. No existing COPD diagnosis
2. History of cardiac arrhythmia
3. Presence of pacemaker/defibrillator
4. Any medical/cognitive/functional condition which renders inability to don/doff/recharge devices and complete symptom questionnaire
5. Have already received 4 or more days of consecutive corticosteroid and/or antibiotic therapy since presenting to medical attention for their AECOPD

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD cohort; Patients with COPD currently experiencing and receiving treatment for an exacerbation.	Device: Biometric wearable devices; Passive data collection using biometric wearable devices.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Bryan A. Ross, MD, FRCPC, MSc (Epi, Physiol), Research Institute of the McGill University Health Centre (RI-MUHC)

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2023
• Primary Completion (Actual): January 15, 2024
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 26, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Disease Progression; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2023-8851

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to data privacy regulations, individual participant data collected during this study is not publicly accessible. However, access to anonymized data may be granted upon evaluation by the trial management group. Additional documents will also be available upon inquiry. All requests should be directed to the corresponding author (BAR).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No