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Clinical effect on uncontrolled asthma using a novel digital automated self-management solution: a physician-blinded randomised controlled crossover trial

Henrik Ljungberg, Anna Carleborg, Hilmar Gerber, Christina Öfverström, Jakob Wolodarski, Faiza Menshi, Mikaela Engdahl, Marianne Eduards, Björn Nordlund
European Respiratory Journal 2019 54: 1900983; DOI: 10.1183/13993003.00983-2019
Henrik Ljungberg
1Lung-Allergy Dept, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden
2Dept of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden
3MediTuner AB, Stockholm, Sweden
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Anna Carleborg
2Dept of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden
3MediTuner AB, Stockholm, Sweden
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Hilmar Gerber
4Sophiahemmet Health Care Centre, Stockholm, Sweden
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Christina Öfverström
4Sophiahemmet Health Care Centre, Stockholm, Sweden
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Jakob Wolodarski
4Sophiahemmet Health Care Centre, Stockholm, Sweden
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Faiza Menshi
2Dept of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden
5Children and Adolescents Health Care Dept in Huddinge, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden
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Mikaela Engdahl
2Dept of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden
5Children and Adolescents Health Care Dept in Huddinge, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden
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Marianne Eduards
6Liljeholmen Health Care Centre, Stockholm Health Care Services (SLSO), Stockholm County Council, Stockholm, Sweden
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Björn Nordlund
1Lung-Allergy Dept, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden
2Dept of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden
3MediTuner AB, Stockholm, Sweden
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  • ORCID record for Björn Nordlund
  • For correspondence: bjorn.nordlund@ki.se
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Abstract

Introduction AsthmaTuner is a novel self-management system consisting of a patient app, a cloud-based storage solution and a healthcare interface. Patients use Bluetooth spirometers to measure lung function (forced expiratory volume in 1 s) and can register symptoms. They then receive immediate feedback on asthma control and an image of the correct inhaler(s) to use and the dose. The aim of this pilot study was to evaluate the effect of AsthmaTuner on symptom control and adherence compared with conventional treatment.

Material and methods This multicentre physician-blinded crossover trial randomised patients in two groups that started with 8 weeks of AsthmaTuner or conventional treatment using a personalised printed treatment plan, with 2 weeks of washout between the crossover treatments. Participants in a primary or paediatric care setting in Sweden with asthma diagnosis, uncontrolled symptoms and Asthma Control Test (ACT) score <20 points were included. Symptom control was analysed using t-tests for the difference between the group means of the sums of ACT scores at each treatment end-visit, with 95% confidence intervals. Medical Adherence Report Scale (MARS) scores captured differences in adherence (remembering to take asthma medication) between treatment periods.

Results The study population consisted of 77 patients (60% females). The ACT score significantly improved with AsthmaTuner compared with conventional treatment (mean ACT difference 0.70, 95% CI 0.06–1.34; p=0.03). Adherence did not improve significantly in all participants, but did improve among those in primary care who used AsthmaTuner an average of once a week or more compared with conventional treatment (mean MARS difference 0.45, 95% CI 0.13–0.77; p=0.01).

Conclusions AsthmaTuner improved symptom control in patients with uncontrolled asthma compared with conventional treatment.

Abstract

AsthmaTuner is an automated electronic clinical decision support system that improves symptom control in patients with uncontrolled asthma http://bit.ly/2MhsNAT

Footnotes

  • This article has supplementary material available from erj.ersjournals.com

  • This study is registered at ClinicalTrials.gov with identifier number NCT02571309.

  • Data sharing: All collected individual participant data are available and after de-identification data that underline the results reported in this article will be shared. Study protocol and statistical analysis plan, informed consent, clinical study report, and data set with analytical code will be available immediately after publication. Data will be available for investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose and for any type of analyses. Proposal may be submitted up to 36 months following article publication. To gain data access, data requestors should be directed to B. Nordlund and will need to sign a data access agreement. All data are stored for 10 years at Karolinska Institutet (Stockholm, Sweden).

  • Conflict of interest: H. Ljungberg is a co-founder and holds shares in the company MediTuner that owns AsthmaTuner.

  • Conflict of interest: A. Carleborg reports personal fees from MediTuner, outside the submitted work; she is an employee of MediTuner and has warrants in the company.

  • Conflict of interest: H. Gerber has nothing to disclose.

  • Conflict of interest: C. Öfverström has nothing to disclose.

  • Conflict of interest: J. Wolodarski has nothing to disclose.

  • Conflict of interest: F. Menshi has nothing to disclose.

  • Conflict of interest: M. Engdahl has nothing to disclose.

  • Conflict of interest: M. Eduards has nothing to disclose.

  • Conflict of interest: B. Nordlund is a co-founder and holds shares in the company MediTuner that owns AsthmaTuner.

  • Support statement: The study was supported by the Bio-X programme of Uppsala BIO, Stockholm County Council Innovation Foundation, Capio Research Foundation, Sweden's Innovation Agency (Vinnova) and MediTuner AB. Funding information for this article has been deposited with the Crossref Funder Registry.

  • Received May 15, 2019.
  • Accepted August 8, 2019.
  • Copyright ©ERS 2019
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Clinical effect on uncontrolled asthma using a novel digital automated self-management solution: a physician-blinded randomised controlled crossover trial
Henrik Ljungberg, Anna Carleborg, Hilmar Gerber, Christina Öfverström, Jakob Wolodarski, Faiza Menshi, Mikaela Engdahl, Marianne Eduards, Björn Nordlund
European Respiratory Journal Nov 2019, 54 (5) 1900983; DOI: 10.1183/13993003.00983-2019

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Clinical effect on uncontrolled asthma using a novel digital automated self-management solution: a physician-blinded randomised controlled crossover trial
Henrik Ljungberg, Anna Carleborg, Hilmar Gerber, Christina Öfverström, Jakob Wolodarski, Faiza Menshi, Mikaela Engdahl, Marianne Eduards, Björn Nordlund
European Respiratory Journal Nov 2019, 54 (5) 1900983; DOI: 10.1183/13993003.00983-2019
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