In patients with severe uncontrolled asthma, does knowledge of adherence and inhaler technique using electronic monitoring improve clinical decision making? A protocol for a randomised controlled trial

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dc.contributor.authorMokoka, Matshediso C.
dc.contributor.authorLombard, Lorna
dc.contributor.authorMacHale, Elaine M.
dc.contributor.authorWalsh, Joanne
dc.contributor.authorCushen, Breda
dc.contributor.authorSulaiman, Imran
dc.contributor.authorMcCarthy, Damien
dc.contributor.authorBoland, Fiona
dc.contributor.authorDoyle, Frank
dc.contributor.authorHunt, Eoin
dc.contributor.authorMurphy, Desmond M.
dc.contributor.authorFaul, John
dc.contributor.authorButler, Marcus
dc.contributor.authorHetherington, Kathy
dc.contributor.authorMark FitzGerald, J.
dc.contributor.authorvan Boven, Job F. M.
dc.contributor.authorHeaney, Liam G.
dc.contributor.authorReilly, Richard B.
dc.contributor.authorCostello, Richard W.
dc.contributor.funderHealth Research Boarden
dc.contributor.funderGlaxoSmithKlineen
dc.date.accessioned2017-06-21T15:42:59Z
dc.date.available2017-06-21T15:42:59Z
dc.date.issued2017-06
dc.date.updated2017-06-21T15:34:09Z
dc.description.abstractIntroduction: Many patients with asthma remain poorly controlled despite the use of inhaled corticosteroids and long-acting beta agonists. Poor control may arise from inadequate adherence, incorrect inhaler technique or because the condition is refractory. Without having an objective assessment of adherence, clinicians may inadvertently add extra medication instead of addressing adherence. This study aims to assess if incorporating objectively recorded adherence from the Inhaler Compliance Assessment (INCA) device and lung function into clinical decision making provides more cost-effective prescribing and improves outcomes. Methods and analysis: This prospective, randomised, multicentre study will compare the impact of using information on adherence to influence asthma treatment. Patients with severe uncontrolled asthma will be included. Data on adherence, inhaler technique and electronically recorded peak expiratory flow rate will be used to promote adherence and guide a clinical decision protocol to guide management in the active group. The control group will receive standard inhaler and adherence education. Medications will be adjusted using a protocol based on Global Initiativefor Asthma (GINA) recommendations. The primary outcome is the between-group difference in the proportion of patients who have refractory disease and are prescribed appropriate medications at the end of 32 weeks. A co-primary outcome is the difference between groups in the rate of adherence to salmeterol/fluticasone inhaler over the last 12 weeks. Secondary outcomes include changes in symptoms, lung function, type-2 cytokine biomarkers and clinical outcomes between both groups. Cost-effectiveness and cost-utility analyses of the INCA device intervention will be performed. The economic impact of a national implementation of the INCA-SUN programme will be evaluated. Ethics and dissemination:The results of the study will be published as a manuscript in peer-reviewed journals. The study has been approved by the ethics committees in the five participating hospitals. Trial registration NCT02307669; Pre-results.en
dc.description.sponsorshipHealth Research Board, Ireland (Grant Number: HRA-D1-2014-683, Grant Code: HRB DI 59)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationMokoka, M. C., Lombard, L., MacHale, E. M., Walsh, J., Cushen, B., Sulaiman, I., Carthy, D. M., Boland, F., Doyle, F., Hunt, E., Murphy, D. M., Faul, J., Butler, M., Hetherington, K., Mark FitzGerald, J., Boven, J. F. v., Heaney, L. G., Reilly, R. B. and Costello, R. W. (2017) 'In patients with severe uncontrolled asthma, does knowledge of adherence and inhaler technique using electronic monitoring improve clinical decision making? A protocol for a randomised controlled trial', BMJ Open, 7(6), e015367. doi:10.1136/bmjopen-2016-015367en
dc.identifier.doi10.1136/bmjopen-2016-015367
dc.identifier.endpagee015367-9en
dc.identifier.issn2044-6055
dc.identifier.issued6en
dc.identifier.journaltitleBMJ Openen
dc.identifier.startpagee015367-1en
dc.identifier.urihttps://hdl.handle.net/10468/4145
dc.identifier.volume7en
dc.language.isoenen
dc.publisherBMJ Publishing Groupen
dc.rights© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. 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/en
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/en
dc.subjectAsthmaen
dc.subjectInhaler techniqueen
dc.subjectElectronic monitoringen
dc.subjectInhaler Compliance Assessment (INCA) deviceen
dc.titleIn patients with severe uncontrolled asthma, does knowledge of adherence and inhaler technique using electronic monitoring improve clinical decision making? A protocol for a randomised controlled trialen
dc.typeArticle (peer-reviewed)en
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