Effectiveness, usability and acceptability of a smart inhaler programme in patients with asthma: protocol of the multicentre, pragmatic, open-label, cluster randomised controlled ACCEPTANCE trial
Open accessAbstract
Introduction: Suboptimal asthma control is associated with incorrect inhaler use and poor medication adherence, which could lead to unfavourable clinical and economic outcomes. Smart inhaler programmes using electronic monitoring devices (EMDs) could support self-management and increase medication adherence and asthma control. However, evidence on long-term benefits and acceptability is scarce. This study aims to investigate the effectiveness of a smart inhaler asthma self-management programme on medication adherence and clinical outcomes in adults with uncontrolled asthma, to evaluate its acceptability and to identify subgroups who would benefit most based on patient characteristics. Methods and analysis: This open-label cluster randomised controlled trial of 12 months will be conducted in primary care in the Netherlands. General practices will be randomly assigned to either intervention or control group. We aim to include 242 patients. The intervention consists of (1) an EMD attached to the patient’s inhaler that measures medication use; (2) a smartphone application to set medication reminders, receive motivational messages and track asthma symptoms; and (3) a portal for healthcare professionals to view data on medication use. The control group is passively monitored by the EMD but cannot view their inhaler data or receive feedback. Eligible patients are adults with suboptimal controlled asthma (Asthma Control Questionnaire score ≥0.75) with evidence of non-adherence established by the EMD during a 6-week run-in period. Primary outcome is the difference in mean medication adherence between intervention and control group. Secondary outcomes include asthma control, asthma-related quality of life, exacerbations, acceptance, cost-effectiveness and whether the effect of the intervention on medication adherence and asthma control is modified by patient characteristics (eg, self-efficacy, medication beliefs and eHealth literacy). Trial registration number NL7854.
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The TAQ-NL was pilot tested and is currently being validated in a Dutch sample.
“The TAQ-NL was pilot tested and is currently being validated in a Dutch sample [40].”
From Personalized exposure and experience sampling method feedback versus exposure as usual for obsessive–compulsive disorder: a study protocol for a randomized controlled trial (2024) · cites this paper as [40]
The Methods > Study outcomes section describes using a Technology Acceptance Questionnaire to assess acceptance, but does not say that a Dutch-language version was pilot tested or is being validated. The same section mentions ongoing Dutch validation of a different questionnaire, the eHealth Literacy Questionnaire. Searches for TAQ pilot testing and validation found no passage establishing the claim. (LLM, conf=0.75)
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Hoogerwerf, E., Greeven, A., Goekoop, R., & Spinhoven, P. (2024) · Trials · doi:10.1186/s13063-023-07780-5 · Cited by 1 · see citing works
“The TAQ-NL was pilot tested and is currently being validated in a Dutch sample [40].”
Method
- Authors
- van de Hei, S. J., Poot, C. C., van den Berg, L. N., Meijer, E., van Boven, J. F. M., Flokstra-de Blok, B. M. J., Postma, M. J., Chavannes, N. H., & Kocks, J. W. H.
- Affiliations
- Department of Health Sciences, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
- Leiden University Medical Center (NL)
- Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands
- Groningen Research Institute for Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, Netherlands
- General Practitioners Research Institute, Groningen, The Netherlands
- University Medical Center Groningen (NL)
- ORCID
- Venue
- BMJ Open Respiratory Research
- Publisher
- BMJ
- Published
- 2022-12
- Volume
- 9
- Issue
- 1
- Pages
- e001400
- ISSN
- 2052-4439 (ISSN-L)
- PMC
- PMC9756226
- OpenAlex
- W4311534025
- Cited by
- 22
- References
- 63
- Citations by year
- 2026: 6 · 2025: 5 · 2024: 7 · 2023: 4
- FWCI
- 4.28
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMJ Open Respiratory Research (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, cc-by-nc)
- Leiden Repository (Leiden University) (submittedVersion, cc-by-nc)
- Data Archiving and Networked Services (DANS) (submittedVersion, cc-by-nc)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, cc-by-nc)
- Funders
- AstraZeneca (Not applicable)
- Topics
- Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
- Health Sciences › Medicine › Physiology › Asthma and respiratory diseases
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- asthma, smart inhalers, electronic monitoring devices, medication adherence, asthma self-management, asthma control, mobile application, medication reminders, patient acceptability, cost-effectiveness, primary care, digital health literacy, self-efficacy, medication beliefs
- MeSH terms
- Adult, Asthma, Humans, Nebulizers and Vaporizers, Quality of Life, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Medication Adherence, Mobile Applications, Pragmatic Clinical Trials as Topic
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