BREATH-TRACHER 2 Study
Research type
Research Study
Full title
The Use of Medical Devices to Monitor COPD Patients Study – An Observational Feasibility Study Running Title: BREATH-TRACHER 2 Study
IRAS ID
328232
Contact name
Alexander Mullen
Contact email
Sponsor organisation
University of Strathclyde, Research Ethics and Governance Manager
Clinicaltrials.gov Identifier
inprogress, inprogress
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Acute exacerbations (worsening of condition) in Chronic Obstructive Pulmonary Disease (COPD) are one of the leading causes of emergency room hospitalisation worldwide. These unscheduled visits result in a substantial economic burden to the healthcare system and a significant disease burden on the individual. At present, there are limited ways of identifying when a patient is clinically deteriorating before they are hospitalised. The proposed study will explore whether remote monitoring of a COPD patient by use of a wearable medical device will allow earlier identification of disease allowing earlier clinical intervention at home and preventing the likelihood of hospitalisation.
The proposed study will assess the sensitivity of a wearable device to measure the physiological signals in COPD patients, who have previously experienced hospitalisation due to exacerbation of their COPD. Participants will be recruited via their GP practice and will be monitored whilst they go about their daily lives. We will follow the patients until they have experienced another exacerbation and then retrospectively process the signal to observe whether the medical device signal was able to detect clinical change 48 – 72 - 96 hrs before hospitalisation (it may vary based on device sensitivity) occurred to see if there was an opportunity to have an earlier escalation of therapy in the community. 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.
The study will have no significant personal direct benefit to the participant as it is only designed to assess signal sensitivity and fidelity at this stage. The research is funded by a Turkish Government Ph.D. scholarship.REC name
London - Stanmore Research Ethics Committee
REC reference
23/LO/0766
Date of REC Opinion
3 Nov 2023
REC opinion
Further Information Favourable Opinion