Evidence map›Paper›PMID 36522130›Full record

ArticleBMJ open respiratory research2022

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.

Susanne J van de Hei, Charlotte C Poot, Liselot N van den Berg, Eline Meijer, Job F M van Boven, Bertine M J Flokstra-de Blok, Maarten J Postma, Niels H Chavannes, Janwillem W H Kocks

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open respiratory research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Susanne J van de Hei *Department of Health Sciences, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands s.j.van.de.hei@umcg.nl.ORCID 0000-0003-2844-6904
Charlotte C Poot *Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.
Liselot N van den BergDepartment of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.
Eline MeijerDepartment of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.
Job F M van BovenGroningen Research Institute for Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
Bertine M J Flokstra-de BlokGeneral Practitioners Research Institute, Groningen, The Netherlands.
Maarten J PostmaDepartment of Health Sciences, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Niels H ChavannesDepartment of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.
Janwillem W H KocksGeneral Practitioners Research Institute, Groningen, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSuboptimal 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).

Indexed as

AsthmaMobile ApplicationsAdultHumansMedication AdherenceMulticenter Studies as TopicNebulizers and VaporizersPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicAsthmaAsthma in primary careInhaler devices

Identifiers

PMID36522130
PMCPMC9756226

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.