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

NCT05776654 | Completed

• 1 other identifier: 2023-8851
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease; Chronic Obstructive Pulmonary Disease Exacerbation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Daily/nightly heart rate and HR variability

  Daily for 21 days

• Daily/nightly peripheral body temperature

  Daily for 21 days

• Activity

  Daily for 21 days

• Sleep metrics

  Daily (nightly) for 21 days.

• Autonomic function/Stress

  Daily for 21 days

Study Arms (1)

COPD cohort

Patients with COPD currently experiencing and receiving treatment for an exacerbation.

Device: Biometric wearable devices

Interventions

Biometric wearable devices DEVICE

Passive data collection using biometric wearable devices.

COPD cohort

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD currently experiencing an exacerbation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bryan A. Ross, MD, FRCPC, MSc (Epi, Physiol)

  Research Institute of the McGill University Health Centre (RI-MUHC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 20, 2023
• Study Start: February 16, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)