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APP-based Medical Device for Education and Training of Inhalation Technique

RecruitingNAAges 16 Years - anyAllKarolinska Institutet
NCT07145632 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Primary aim: To investigate if app-based education and training of inhalation technique improves the rate of successful inhalation techniques compared with control group at 6-12 weeks follow-up visit. Secondary aims: To evaluate the feasibility, usability, and safety of the investigational during the study period. Study design: Two-armed, parallel-designed, individual single-blinded stratified randomisation by inhaler (DPI/MDI/both DPI and MDI) controlled trial with assignment (1:1) to (1) standard care and app-based education and training of inhalation technique or (2) standard education of inhalation technique over 6-12 weeks. Subjects: Subjects from the age of 16 years with documented diagnosis of asthma and/or COPD, daily treated with dry powder inhaler (DPI) or metered dose inhaler (MDI), or both, will be invited to voluntarily participate. Exclusion criteria is age \<16 years, n

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📋 Eligibility rules (as published)
Inclusion Criteria: * Subjects at age \>16 years * Willing to voluntarily participate in the study and give electronic written informed consent * Prescribed with daily inhalation therapy through DPI and/or MDI for doctor's diagnosed asthma or COPD. Exclusion Criteria: * Age \<16 years, * No access to smartphone of type Android or iPhone * No access to electronic signature for informed consent * Plan to withdraw inhaler treatment including daily DPI and/or MDI the following 6-12 weeks. * Medical condition affecting the ability to independently inhale or use DPI or MDI device(s).
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What it tests

  • App-based education and training of inhalation technique
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Where

3 sites
Uppsala University Hospital, Lung and Allergy Department
Uppsala, Sweden
Healthcare centre
Styrsö, Sweden
Healthcare Centre
Boxholm, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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