Domiciliary Monitoring to Predict Exacerbations of COPD

NCT03003702 | Completed

• 1 other identifier: 16/LO/1120
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a common, long term condition of the lungs that is usually caused by cigarette smoking. In addition to daily symptoms and limitation in activities, patients are prone to developing chest infections called 'exacerbations'. Exacerbations are a big problem: unpleasant for patients, and sometimes severe enough to cause hospital admission (and therefore health facilities pressures) and death. Reducing the impact of exacerbations is very important. Investigators have previously shown that earlier treatment of COPD exacerbations results in faster recovery, and reduced chance of hospital admission. Helping patients to detect exacerbations early is therefore important. Investigators have also recently shown that monitoring heart rate and oxygen saturation via a finger probe may assist in this. However, measuring these variables when the patient is awake means they can be affected by other things, such as exercise and anxiety. Our new idea is that measuring heart rate and oxygen level overnight, when a patient is asleep, will give the best chance of detecting COPD exacerbations early and our study will test that. Investigators will randomly allocate 77 patients with COPD recruited from our service in London to standard monitoring, or overnight monitoring, for up to six months or the first exacerbation, whichever is sooner. Investigators will then analyse whether overnight monitoring was able to detect exacerbations earlier, and therefore could be used to help patients get treatment earlier. A subset of participants will also wear an activity monitor overnight for the first two weeks, so that Investigators can assess the effect (if any) of overnight awake periods (such as trips to the bathroom) on the heart rate and saturation recording.

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the difference in time to receive treatment from exacerbation onset as defined by symptoms, compared to exacerbation onset as defined by change in physiology

  6 months

Study Arms (2)

ETH

EXPERIMENTAL

Overnight monitoring

Device: Nonin

CTH

OTHER

Morning monitoring

Device: Nonin

Interventions

Nonin DEVICE

CTH; ETH

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed with COPD (smoking history of ≥10 pack years and FEV1/VC \< 0.7 post-bronchodilator).
• Patient who had two or more self-reported moderate or severe COPD exacerbations in the past 12 months.
• Patient who can use study equipment and attend appointments.
• Can communicate in English.

You may not qualify if:

• Patient who was diagnosed with obstructive sleep apnea (through a self-report and/or a result of Stop Bang and Epworth questionnaires).
• Patient with co-morbidity preventing taking part.
• Patients already involved in an ongoing research study.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Royal Free Hospital NHS

London, NW3 2PF, United Kingdom

Location

Related Publications (1)

• Al Rajeh AM, Aldabayan YS, Aldhahir A, Pickett E, Quaderi S, Alqahtani JS, Mandal S, Lipman MC, Hurst JR. Once Daily Versus Overnight and Symptom Versus Physiological Monitoring to Detect Exacerbations of Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Nov 13;8(11):e17597. doi: 10.2196/17597.

  PMID: 33185560 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: December 28, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

GB (1)