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
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...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e059929.full |
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| author | Job F. M. van Boven Boudewijn H.J. Dierick Maria Achterbosch Sandra Been-Buck Titia Klemmeier Susanne J. van de Hei Paul Hagedoorn Huib A.M. Kerstjens Janwillem W.H. Kocks |
| author_facet | Job F. M. van Boven Boudewijn H.J. Dierick Maria Achterbosch Sandra Been-Buck Titia Klemmeier Susanne J. van de Hei Paul Hagedoorn Huib A.M. Kerstjens Janwillem W.H. Kocks |
| author_sort | Job F. M. van Boven |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-79d662388d954c4fa59755d80e7f5e47 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-79d662388d954c4fa59755d80e7f5e472025-01-28T06:45:11ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-059929Can 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 trialJob F. M. van Boven0Boudewijn H.J. Dierick1Maria Achterbosch2Sandra Been-Buck3Titia Klemmeier4Susanne J. van de Hei5Paul Hagedoorn6Huib A.M. Kerstjens7Janwillem W.H. Kocks8Department of Clinical Pharmacy & Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The NetherlandsDepartment of Clinical Pharmacy & Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The NetherlandsDepartment of Clinical Pharmacy & Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The NetherlandsDepartment of Pulmonology, Martini Hospital, Groningen, The NetherlandsDepartment of Pulmonology, Martini Hospital, Groningen, The NetherlandsGroningen Research Institute for Asthma and COPD (GRIAC), Groningen, The NetherlandsPharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, Groningen, The NetherlandsGroningen Research Institute for Asthma and COPD (GRIAC), Groningen, The NetherlandsMedication Adherence Expertise Center of the northern Netherlands (MAECON), Groningen, The NetherlandsIntroduction 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.https://bmjopen.bmj.com/content/12/6/e059929.full |
| spellingShingle | Job F. M. van Boven Boudewijn H.J. Dierick Maria Achterbosch Sandra Been-Buck Titia Klemmeier Susanne J. van de Hei Paul Hagedoorn Huib A.M. Kerstjens Janwillem W.H. Kocks 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/6/e059929.full |
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