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Abstract
Introduction Non-adherence to asthma daily controller medications is a common problem, reported to be responsible for 60% of asthma-related hospitalisations. The mean level of adherence for asthma medications is estimated to be as low as 22%. Therefore, objective measurements of adherence to medicine are necessary. This virtual observational study is designed to measure the usability of an electronic monitoring device platform that measures adherence. Understanding how patients use the BreatheSmart mobile technology at home is essential to assess its feasibility as a solution to improve medication adherence. We anticipate this approach can be applied to real-world environments as a cost-effective solution to improve medication adherence.
Methods and analysis This is a virtual 6-month observational study of 100 adults (≥18 years) with an asthma diagnosis, using inhaled corticosteroids for at least 3 months. Participants will be recruited in the USA through ad placements online. All participants receive wireless Bluetooth-enabled inhaler sensors that track medication usage and an mSpirometerTM capable of clinical-grade lung function measurements, and download the BreatheSmart mobile application that transmits data to a secure server. All analyses are based on an intention-to-treat. Usability is assessed by patient questionnaires and question sessions. Simple paired t-test is used to assess significant change in Asthma Control Test score, quality of life (EuroQol-5D questionnaire) and lung function.
Ethics and dissemination No ethical or safety concerns pertain to the collection of these data. Results of this research are planned to be published as soon as available.
Trial registration number NCT03103880.
- telemanagement
- mHealth
- telehealth
- telemedicine
- real-time reminders
- text message reminders
- medication adherence
- inhaled corticosteroids
- asthma
- asthma control
- medication adherence
- mobile health
- patientmonitoring
- mobile health
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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Footnotes
Contributors EM drafted portions of the paper, prepared the article for submission and iterated on draft versions of the paper. AC contributed to the design of the protocol, iterated on draft versions of the paper, assisted in management of the paper submission and provided clinical expertise. AT contributed to the design of the protocol, drafted portions of the paper, iterated on draft versions of the paper and assisted in management of the paper submission. RK contributed to the design of the protocol and drafting of the paper. MM oversaw the creation and submission of the protocol and provided senior clinical and professional expertise and guidance.
Funding This work was supported Cohero Health. This research received no specific grant from any other funding agency in the public or not-for-profit sectors.
Competing interests None declared.
Patient consent This is a protocol paper and therefore this article contains no personal medical information about any identifiable living individuals, and therefore does not require the patient’s explicit consent for publication.
Ethics approval Approval Number: 20162351. Board Name: Western Institutional Review Board Board. Affiliation: WIRB-Copernicus Group. Board Contact: Western Institutional Review Board, 1019 39th Avenue SE, Suite 120, Puyallup, WA 98374-2115.
Provenance and peer review Not commissioned; externally peer reviewed.