The Use of Medical Devices to Monitor Chronic Obstructive Pulmonary Disease Patients Study BREATH-TRACHER 2 (BREATH-TRACHER)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: COPD Exacerbation Acute
• Intervention / Treatment: Device: Frontier X2

Detailed Description

This study will assess the sensitivity of a wearable device to measure the physiological signals in COPD patients, who have previously experienced hospitalization due to exacerbation of their COPD.

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Alex Mullen, PhD; Phone Number: 441415484409; Email: a.mullen@strath.ac.uk

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G83 0UE
    • Oakview Medical Practice in Alexandria
    • Contact: Alexander Mullen; Phone Number: +44 (0) 1415484409; Email: a.mullen@strath.a.cuk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population for this research consists of individuals diagnosed with COPD (Chronic Obstructive Pulmonary Disease) who have a history of exacerbation-induced hospitalization within the one-year period preceding recruitment. The target number of participants in this study is 30.

Description

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.
• Participation in an interventional clinical study within 3 months of Visit 1 or participation in a study using an investigational medicinal product (IMP) either in the previous 3 months or in the interval from last using the IMP to 5 times its half-life.
• Patients with other significant lung disease, unable to consent, unable to use the technology (e.g. inability to use the data device, or complete the questionnaires), or at the clinician's discretion for other more significant medical/social reasons.
• Known allergy to strap.
• On long-term oxygen therapy.
• Acute exacerbation of COPD within 6 weeks prior to inclusion.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
People with COPD; The study population for this research consists of individuals diagnosed with COPD (Chronic Obstructive Pulmonary Disease) who have a history of exacerbation-induced hospitalization within the one-year period preceding recruitment.	Device: Frontier X2; Frontier X2 device will be used to measuring for physiological changes (breathing rate, heart rate, ECG, and heart rate variabilities) in people with COPD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical changes before COPD exacerbations	Participants' breath rates, heart rate and ECG levels will be measured in their daily lives, and clinical changes will be examined when the clinical health of a COPD sufferer is starting to deteriorate.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device usage	To assess the usability and comfort of the wearable technology, assessed by qualitative interviews and field notes during fortnightly follow-up appointments from the perspective of the volunteer	18 months

Collaborators and Investigators

• Sponsor: University of Strathclyde
• Collaborators: Fourth Frontier Technologies Ltd

Publications and helpful links

General Publications

• Seemungal TA, Hurst JR, Wedzicha JA. Exacerbation rate, health status and mortality in COPD--a review of potential interventions. Int J Chron Obstruct Pulmon Dis. 2009;4:203-23. doi: 10.2147/copd.s3385. Epub 2009 Jun 11.
• Hawthorne G, Richardson M, Greening NJ, Esliger D, Briggs-Price S, Chaplin EJ, Clinch L, Steiner MC, Singh SJ, Orme MW. A proof of concept for continuous, non-invasive, free-living vital signs monitoring to predict readmission following an acute exacerbation of COPD: a prospective cohort study. Respir Res. 2022 Apr 26;23(1):102. doi: 10.1186/s12931-022-02018-5.
• Donaldson GC, Law M, Kowlessar B, Singh R, Brill SE, Allinson JP, Wedzicha JA. Impact of Prolonged Exacerbation Recovery in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Oct 15;192(8):943-50. doi: 10.1164/rccm.201412-2269OC.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: medical device; heart rate; ECG; remote monitoring technologies; respiratory signal
• Other Study ID Numbers: UEC23/71

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data collected during the study will be immediately anonymized and will not be shared with third parties.

Drug and device information, study documents

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