The Use of Medical Devices to Monitor COPD Patients Study - An Observational Feasibility Study

University of Strathclyde1 site in 1 country30 target enrollmentJune 24, 2024

ConditionsCOPD Exacerbation Acute

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: COPD Exacerbation Acute
Sponsor: University of Strathclyde
Enrollment: 30
Locations: 1
Primary Endpoint: Clinical changes before COPD exacerbations
Status: Enrolling By Invitation
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The proposed study will explore whether remote monitoring of a COPD patient can be undertaken using a wearable medical device.

Detailed Description

The proposed study will assess the sensitivity of a wearable device to measure the respiratory signals in COPD patients, who have previously experienced hospitalisation due to exacerbation of their COPD. Participation in the study involves wearing a small sensor. The monitoring device will also assess the effectiveness of medication prescribed before, during, and after the COPD exacerbation to see if it has a role in directing day-to-day therapy.

Registry

clinicaltrials.gov

Start Date

June 24, 2024

End Date

September 1, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Strathclyde

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Any person aged 18 years or over.
•Current diagnosis of COPD.
•Be willing and able to comply with study procedures and be available for study visits. • Be able to use a 'smartphone or computer'.
•Be able to give written consent.
•Able to understand written and spoken English.

Exclusion Criteria

•Inability to give written informed consent.
•Known respiratory disorders are other than COPD which, in the opinion of the investigator, is the main contributor to the patient's symptoms (e.g. asthma, lung cancer, sarcoidosis, and other interstitial lung diseases (ILDs), tuberculosis, lung fibrosis, cystic fibrosis, and non-COPD related bronchiectasis).
•Known history of significant systemic and other organ-related diseases, other than COPD, which in the opinion of the investigator, is likely to interfere with the study or impact on subject safety (e.g. severe rheumatoid arthritis and Lupus, kidney, liver, endocrine, psychological disorders).
•Known to be severely alpha-1-antitrypsin deficient (PI, SZ or ZZ).
•Based on their medical record if there is any social violence/substance misuse.
•Having undergone lung surgery (e.g. lung volume reduction, lobectomy) within the last 6 months.
•Have cancer or other terminal condition which, in the opinion of the investigator, has a mortality of 12 months or less. • Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
•Taking high-dose oral corticosteroid medication (equivalent to daily dose of ≥10 mg of prednisolone) for more than 3 consecutive months.
•Pregnancy
•Patients already involved in an ongoing research study.