Multisensor Non-invasive Telemonitoring System for Prediction of Chronic Obstructive Pulmonary Disease Exacerbation: Trial Design

Abstract

Background: Chronic Obstructive Pulmonary Disease (COPD) is a debilitating lung disease. COPD is typically managed through pharmacological therapies however nonpharmacological therapies such as pulmonary rehabilitation can be added for treatment. Measuring a patient’s progress in a pulmonary rehabilitation program relies on pulmonary function tests, exercise testing, and patient reported outcomes. There is no gold standard for monitoring progress with the patient in pulmonary rehabilitation and no biomarkers are established to indicate responsiveness to treatment.

Objective: Primary objective of this study is to evaluate the clinical utility of the accelerateIQ system in the management of patients in a pulmonary rehabilitation program and detection of COPD exacerbations at 90 days.

Design: This is a single center, nonrandomized non-interventional study to evaluate the accuracy of remote monitoring and analytical platform for the prediction of COPD exacerbations.

Analysis: Correlation of algorithmic alerts generated by noninvasive telemonitoring system to a verified COPD exacerbation event.

Conclusion: It is important to explore new methods for monitoring patients through the therapeutic process. The study is expected to begin enrollment in December 2018 at North Shore University Hospital with completion in April 2019.