دورية أكاديمية
Can electronic monitoring with a digital smart spacer support personalised medication adherence and inhaler technique education in patients with asthma?: Protocol of the randomised controlled OUTERSPACE trial.
| العنوان: | Can electronic monitoring with a digital smart spacer support personalised medication adherence and inhaler technique education in patients with asthma?: Protocol of the randomised controlled OUTERSPACE trial. |
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| المؤلفون: | Dierick BHJ; Department of Clinical Pharmacy & Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.; Department of General Practice & Elderly Care Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.; Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, The Netherlands., Achterbosch M; Department of Clinical Pharmacy & Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Been-Buck S; Department of Pulmonology, Martini Hospital, Groningen, The Netherlands., Klemmeier T; Department of Pulmonology, Martini Hospital, Groningen, The Netherlands., van de Hei SJ; Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, The Netherlands.; Department of Health Sciences, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Hagedoorn P; Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands.; Medication Adherence Expertise Center of the northern Netherlands (MAECON), Groningen, The Netherlands., Kerstjens HAM; Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, The Netherlands.; Department of Pulmonary Diseases and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Kocks JWH; Medication Adherence Expertise Center of the northern Netherlands (MAECON), Groningen, The Netherlands.; Observational and Pragmatic Research Institute, Singapore.; General Practitioners Research Institute, Groningen, The Netherlands., van Boven JFM; Department of Clinical Pharmacy & Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands j.f.m.van.boven@umcg.nl.; Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, The Netherlands.; Medication Adherence Expertise Center of the northern Netherlands (MAECON), Groningen, The Netherlands. |
| المصدر: | BMJ open [BMJ Open] 2022 Jun 13; Vol. 12 (6), pp. e059929. Date of Electronic Publication: 2022 Jun 13. |
| نوع المنشور: | Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [London] : BMJ Publishing Group Ltd, 2011- |
| مواضيع طبية MeSH: | Asthma*/drug therapy , Bronchodilator Agents*, Administration, Inhalation ; Electronics ; Humans ; Medication Adherence ; Multicenter Studies as Topic ; Nebulizers and Vaporizers ; Randomized Controlled Trials as Topic |
| مستخلص: | Introduction: Medication adherence and inhaler technique in patients with asthma remain suboptimal. A digital, smart spacer may support personalised adherence and inhaler technique education. The aim of this study is to assess the feasibility of undertaking a definitive randomised controlled trial of personalised, smart spacer data-driven education and explore clinical benefits. Methods and Analysis: We present the design of the multicentre, randomised controlled OUtcomes following Tailored Education and Retraining: Studying Performance and AdherenCE feasibility trial of 2 months. Patients will be recruited from four Dutch general practices. At t=-1, patients with asthma ≥18 years using inhaled corticosteroids±long-acting beta-agonists±short-acting beta-agonists administered with a pressurised-metered-dose-inhaler and spacer (n=40) will use a smart spacer for 1 month. The rechargeable CE-marked smart spacer (Aerochamber Plus with Flow Vu) includes a sensor that monitors adherence and inhalation technique to prescribed dosing regimen of both maintenance and reliever inhalers. After 1 month (t=0), patients are 1:1 randomised into two groups: control group (usual care) versus intervention group (personalised education). At t=-1, t=0 and t=1 month, the Asthma Control Questionnaire (ACQ), Work Productivity and Activity Impairment (WPAI) questionnaire and Test of Adherence to Inhalers (TAI) are administered and fractional exhaled nitric oxide (FeNO) is assessed. At t=0 and t=1, spirometry is performed. At t=1, usability and satisfaction will be analysed using the System Usability Scale and interviews with patients and healthcare providers. Primary outcome is the overall feasibility of a definitive trial assessed by patient recruitment speed, participation and drop-out rate. Secondary outcomes are patient and healthcare provider satisfaction and exploratory clinical outcomes are adherence, inhaler technique, TAI score, FeNO, lung function, ACQ and WPAI. Ethics and Dissemination: Ethical approval was obtained from the RTPO in Leeuwarden, Netherlands (number: NL78361.099.21). Patients will provide written informed consent. Study findings will be disseminated through conferences and peer-reviewed scientific and professional journals. Trial Registration Number: NL9637. Competing Interests: Competing interests: HAMK reports a fee for a one time consultancy outside the realm of this study, and grants and fees for consultancy or advisory board participation from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline and Novartis all outside of the submitted work. All were paid to his institution. JK reports grants, personal fees and non-financial support from AstraZeneca, grants, personal fees and non-financial support from Boehringer Ingelheim, grants and personal fees from Chiesi Pharmaceuticals, grants, personal fees and non-financial support from GSK, grants from Mundi Pharma, grants and personal fees from TEVA, personal fees from MSD, personal fees from COVIS Pharma, outside the submitted work; and Janwillem Kocks holds 72.5% of shares in the General Practitioners Research Institute. JFMvB received grants and/or consultancy fees from AstraZeneca, Chiesi, European Commission COST (COST Action 19132), GSK, Lung Alliance Netherlands, Novartis, Teva, and Trudell Medical, outside the submitted work and all paid to his institution. Other authors declare no relevant conflicts of interest. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
| References: | J Allergy Clin Immunol Pract. 2021 Nov;9(11):3979-3994. (PMID: 34111571) J Allergy Clin Immunol Pract. 2017 Jul - Aug;5(4):1071-1081.e9. (PMID: 28286157) J Allergy Clin Immunol Pract. 2016 Sep-Oct;4(5):835-46. (PMID: 27587317) Cochrane Database Syst Rev. 2017 Mar 13;3:CD012286. (PMID: 28288272) J Allergy Clin Immunol Pract. 2020 Feb;8(2):635-644. (PMID: 31568927) Eur Respir J. 2018 Apr 4;51(4):. (PMID: 29519922) ERJ Open Res. 2018 Jun 18;4(2):. (PMID: 29928649) Lancet Respir Med. 2015 Mar;3(3):210-9. (PMID: 25617215) Expert Rev Pharmacoecon Outcomes Res. 2020 Oct;20(5):437-453. (PMID: 32902346) J Aerosol Med Pulm Drug Deliv. 2016 Apr;29(2):142-52. (PMID: 26230150) Eur Respir J. 1999 Oct;14(4):902-7. (PMID: 10573240) Clin Exp Allergy. 2012 Nov;42(11):1566-74. (PMID: 23106657) NPJ Prim Care Respir Med. 2021 Feb 16;31(1):9. (PMID: 33594082) J Thorac Dis. 2021 Jun;13(6):3846-3864. (PMID: 34277075) Thorax. 2017 Apr;72(4):347-354. (PMID: 27815524) Chest. 2016 Aug;150(2):394-406. (PMID: 27060726) J Allergy Clin Immunol Pract. 2018 May - Jun;6(3):785-793. (PMID: 29339126) J Allergy Clin Immunol Pract. 2020 Mar;8(3):1124-1125.e4. (PMID: 31593777) BMJ. 2013 Jan 08;346:e7586. (PMID: 23303884) Lancet Respir Med. 2017 Sep;5(9):691-706. (PMID: 28822787) J Allergy Clin Immunol. 2014 Dec;134(6):1260-1268.e3. (PMID: 25062783) J Allergy Clin Immunol Pract. 2016 Sep-Oct;4(5):802-12. (PMID: 27587314) Pharmacoeconomics. 1993 Nov;4(5):353-65. (PMID: 10146874) Eur Respir J. 2021 Jun 4;57(6):. (PMID: 33334936) Curr Opin Pulm Med. 2019 Jan;25(1):18-26. (PMID: 30461535) |
| فهرسة مساهمة: | Keywords: Asthma; Chronic airways disease; EDUCATION & TRAINING (see Medical Education & Training) |
| المشرفين على المادة: | 0 (Bronchodilator Agents) |
| تواريخ الأحداث: | Date Created: 20220613 Date Completed: 20220615 Latest Revision: 20220716 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC9196171 |
| DOI: | 10.1136/bmjopen-2021-059929 |
| PMID: | 35697450 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2044-6055 |
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| DOI: | 10.1136/bmjopen-2021-059929 |