Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 1, 2019
Date Accepted: Jan 7, 2020
A Proof-of-concept, Open-label, Feasibility Study to Evaluate Mobile Applications and Biosensing (mHealth) Devices to Monitor Physical Activity and Respiratory Function in Smokers with and without Respiratory Symptoms/COPD
ABSTRACT
Background:
Chronic obstructive pulmonary disease (COPD) is a global public health problem. Continuous monitoring is important for the management of chronic diseases including COPD. Telemonitoring using mobile health (mHealth) devices has the potential to promote self-management, improve control, increase quality of life, and prevent hospital admissions.
Objective:
This study aims to demonstrate whether a large-scale study to assess using of mHealth devices in improving the treatment, assessment, compliance, and outcomes of chronic diseases, particularly COPD and cardio-metabolic syndrome, is feasible and will allow selecting the appropriate design and characteristics of the large-scale study.
Methods:
Three cohorts of nine participants each are enrolled to use mHealth devices for 90 days while undergoing the current standard of care: “non-COPD”, otherwise healthy, smokers; nine “grey zone” smokers (i.e., FEV1/FVC ≥0.70 after bronchodilator treatment, CAT ≥10); nine smokers diagnosed with Stage 1 - 3 COPD. Rates of recruitment, retention, and adherence are measured. Two mHealth devices are utilized in the study: Anamed OEM device (distance, energy expenditure, heart rate, heart rate variability) and Air Next mobile spirometry device. The mHealth devices are compared against industry standards. Additionally, a questionnaire is administered to assess the participants’ perceptions of the mHealth technologies used.
Results:
Participants inclusion started in June 2019. Study results will be published in peer-reviewed scientific journals.
Conclusions:
This study will demonstrate whether a large-scale study to assess using of mHealth devices in improving the treatment, assessment, compliance, and outcomes of chronic diseases, particularly COPD and cardio-metabolic syndrome, is feasible and will allow selecting the appropriate design and characteristics of the large-scale study. Clinical Trial: ClinicalTrials.gov NCT04081961; https://clinicaltrials.gov/ct2/show/NCT04081961
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