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    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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    Authors
    Mokoka, Matshediso C
    Lombard, Lorna
    MacHale, Elaine M
    Walsh, Joanne
    Cushen, Breda
    Sulaiman, Imran
    Carthy, Damien Mc
    Boland, Fiona
    Doyle, Frank
    Hunt, Eoin
    Murphy, Desmond M
    Faul, John
    Butler, Marcus
    Hetherington, Kathy
    Mark FitzGerald, J
    Boven, Job Fm van
    Heaney, Liam G
    Reilly, Richard B
    Costello, Richard W
    Show allShow less
    Issue Date
    2017-06-15
    Keywords
    ASTHMA
    TREATMENT ADHERENCE
    
    Metadata
    Show full item record
    Citation
    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. 2017, 7 (6):e015367 BMJ Open
    Publisher
    BMJ Open
    Journal
    BMJ open
    URI
    http://hdl.handle.net/10147/621478
    DOI
    10.1136/bmjopen-2016-015367
    PubMed ID
    28619778
    Additional Links
    http://bmjopen.bmj.com/content/7/6/e015367.long
    Abstract
    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.
    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.
    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.
    NCT02307669; Pre-results.
    Item Type
    Article
    Language
    en
    ISSN
    2044-6055
    ae974a485f413a2113503eed53cd6c53
    10.1136/bmjopen-2016-015367
    Scopus Count
    Collections
    Royal College of Surgeons in Ireland (RCSI)

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