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

BMJ Open Respiratory Research, vol. 9, pp. e001400

Abstract

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.

Authors 9

1. Susanne J. van de Hei corresponding

   University Medical Center Groningen · University of Groningen · General Practitioners Research Institute

   Affiliation as printed

   Department of Health Sciences, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands

   General Practitioners Research Institute, Groningen, The Netherlands

   Groningen Research Institute for Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, Netherlands

2. Charlotte C Poot Aachen Department of Public Health and Primary Care

   Leiden University Medical Center

   Affiliation as printed

   Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands

3. Liselot Nicoline van den Berg Aachen Department of Public Health and Primary Care

   Leiden University Medical Center

   Affiliation as printed

   Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands

4. Eline M. Meijer Aachen Department of Public Health and Primary Care

   Leiden University Medical Center

   Affiliation as printed

   Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands

5. Job F. M. van Boven

   University Medical Center Groningen · University of Groningen

   Affiliation as printed

   Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands

   Groningen Research Institute for Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, Netherlands

   Medication Adherence Expertise Center of the Northern Netherlands (MAECON), Groningen, The Netherlands

6. Bertine M.J. Flokstra-de Blok

   University Medical Center Groningen · University of Groningen · General Practitioners Research Institute

   Affiliation as printed

   Department of Pediatric Pulmonology and Pediatric Allergology, Beatrix Children's Hospital, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands

   General Practitioners Research Institute, Groningen, The Netherlands

   Groningen Research Institute for Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, Netherlands

7. Maarten Jacobus Postma

   University Medical Center Groningen · University of Groningen

   Affiliation as printed

   Department of Health Sciences, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands

8. Niels Henrik Chavannes Aachen Department of Public Health and Primary Care

   Leiden University Medical Center

   Affiliation as printed

   Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands

9. Janwillem W.H. Kocks

   University Medical Center Groningen · University of Groningen · General Practitioners Research Institute · Observational & Pragmatic Research Institute

   Affiliation as printed

   General Practitioners Research Institute, Groningen, The Netherlands

   Groningen Research Institute for Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, Netherlands

   Medication Adherence Expertise Center of the Northern Netherlands (MAECON), Groningen, The Netherlands

   Observational and Pragmatic Research Institute, Singapore