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

NCT ID: NCT05776654

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-16

Study Completion Date

2024-01-15

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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Chronic Obstructive Pulmonary Disease Exacerbation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD cohort

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

Biometric wearable devices

Intervention Type DEVICE

Passive data collection using biometric wearable devices.

Interventions

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Biometric wearable devices

Passive data collection using biometric wearable devices.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Bryan Ross

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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McGill University Health Centre

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2023-8851

Identifier Type: -

Identifier Source: org_study_id

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