Evidence map›Paper›PMID 32943094›Full record

ArticleTrials2020

Does immediate smart feedback on therapy adherence and inhalation technique improve asthma control in children with uncontrolled asthma? A study protocol of the IMAGINE I study.

Esther T Sportel, Martijn J Oude Wolcherink, Job van der Palen, Anke Lenferink, Boony J Thio, Kris L L Movig, Marjolein G J Brusse-Keizer

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 13% of its field
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, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Digital remote maintenance inhaler adherence interventions in COPD: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2024
    Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
  6. Tele-Monitoring Applications in Respiratory Allergy.Journal of clinical medicine · 2024
    Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Assessing adherence to inhaled therapies in asthma and the emergence of electronic monitoring devices.European respiratory review : an official journal of the European Respiratory Society · 2022
    Review
  12. Observational
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

7 authors at 2 institutions in 1 country.

Esther T SportelDepartment of Clinical Pharmacy, Medisch Spectrum Twente, Enschede, The Netherlands. e.sportel@mst.nl.
Martijn J Oude WolcherinkDepartment of Paediatrics, Medisch Spectrum Twente, Enschede, The Netherlands.
Job van der PalenDepartment of Research Methodology, Measurement and Data Analysis, University of Twente, Enschede, The Netherlands.
Anke LenferinkDepartment of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, The Netherlands.
Boony J ThioDepartment of Paediatrics, Medisch Spectrum Twente, Enschede, The Netherlands.
Kris L L MovigDepartment of Clinical Pharmacy, Medisch Spectrum Twente, Enschede, The Netherlands.
Marjolein G J Brusse-KeizerDepartment of Epidemiology, Medisch Spectrum Twente, Enschede, The Netherlands.
Medisch Spectrum Twente · NLUniversity of Twente · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMany asthmatic children suffer from uncontrolled asthma with frequent exacerbations, despite an optimal treatment plan using inhalation medication. Studies have shown that therapy adherence and inhalation technique are often suboptimal in asthmatic children, but these have traditionally been hard to measure. A novel device functioning as an add-on to the inhaler has been developed to measure both aspects by recording vibration patterns during inhalation. This data can be converted to smart feedback and provided to patients immediately via a mobile application. The aim of this study is to improve asthma control in children between 6 and 18 years old by providing immediate smart feedback on the intake of inhalation medication. Asthma control will be measured by forced expiratory volume in 1 s, (Childhood) Asthma Control Test ((c-)ACT) score, and lung function variability and reversibility.

methodsThe study will be performed in Medisch Spectrum Twente (Enschede, The Netherlands). The goal is to include 68 uncontrolled moderate to severe asthmatic children between 6 and 18 years old who receive controller inhalation medication through the Nexthaler®, Ellipta®, or Spiromax®. The study consists of three phases. Phase 1 is observational and will last 4 weeks to observe the baseline adherence and inhalation technique as monitored by the add-on device. A randomised controlled trial lasting 6 weeks will be performed in phase 2. Patients in the intervention group will receive immediate smart feedback about the performed inhalations via a mobile application. In the control group, adherence and inhalation technique will be monitored, but patients will not receive feedback. In phase 3, also lasting 6 weeks, the feedback will be ceased for all children and revision of current therapy may occur, depending on the findings in phase 2. Asthma control can be assessed by means of spirometry (both at home and in the hospital) and (c-)ACT questionnaires. DISCUSSION: Immediate smart feedback may improve therapy adherence and inhalation technique, and thus asthma control in children and prevent unnecessary switches to targeted biologics. Performing this study in children is desired, since they are known to react differently to feedback and medication than adults.

trial registrationDutch Trial Register NL7705 . Registered on 29 April 2019.

Indexed as

Anti-Asthmatic AgentsAsthmaAdministration, InhalationAdolescentAdultChildFeedbackHumansMedication AdherenceNebulizers and VaporizersNetherlandsRandomized Controlled Trials as TopicAnti-Asthmatic AgentsAsthmaAsthma controlChildrenFeedbackInhalation medicationInhalation techniqueMonitoringPaediatricsTherapy adherence

Identifiers

PMID32943094
PMCPMC7499851
OpenAlexW3087470912

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.