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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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, no access to use BankID or similar electronic personal identification service, not using smartphone of type Android or iPhone, plan to stop use DPI and/or MDI the following 6-12 weeks from inclusion. No able to independently handle and inhale through DPI or MDI device. Total sample size: Eighty subjects (females and males) with daily treatment for COPD or asthma will be sufficient, based on the assumption of 25% percentage improvement in success rate of correct inhalation technique in the interventional group compared with control group (75% versus 50%) with 80% power at 5% significance level, including dropouts at 6-12 weeks follow-up visit. Intervention: At the baseline visit patients will be randomised to app-based intervention consisting of education and training of inhalation technique of all inhalers used on daily basis (the inhalation app-module). Stratified randomisation based on type of inhaler(s); MDI, DPI or both MDI and DPI will be applied. The intervention is the inhalation app-module, which is a medical device that is embedded the AsthmaTuner app. The AsthmaTuner app is a CE-marked cloud-based system, provided by MediTuner AB in Stockholm, Sweden. The intervention group will be instructed to use the inhalation app-module on daily basis to improve their inhalation technique. Control group: Standard education of inhalation technique using list of standardised criteria and non-app-based education of inhaler technique. Endpoints: Primary endpoint is the rate of subjects with successful inhalation techniques based on subjective critical endpoints (CIP Table 2) and the following objective endpoints at the 6-12 weeks follow up visit: * DPI: PIF \> 30 L/Min, time to PIF \<0.5 seconds measured with the investigational device. * MDI: inspiration time (\> 3 seconds) and PIF less than 60 L/Min measured with the investigational device. Procedures: At baseline, a trained respiratory nurse will subjectively assess and train each patient's inhalation technique according to defined criteria of device handling (standard education). The AsthmaTuner app is downloaded to a smartphone or tablet computer (Ipad) that is wirelessly (Bluetooth) connected to a home spirometer. In this study the Bluetooth spirometer AsthmaTuner from MIR will be used. Education and training of inhalation technique will include measurement of inhalation flow with an adjustable resistance mounted on the spirometer, Airflow Trainer (MIR). The app gives instruction to set the resistance, so it corresponds to the selected inhaler. Questionnaires and interviews will collect information about the feasibility, safety and experienced usability of the investigational device. Analysis: The rate of subjects with successful inhalation technique at 6-12-week visit determined by fulfilling objective and subjective critical endpoints in intention-to-treat approach. The effect of using the inhalation app-module will be analysed with logistic regression analysis across randomisation groups. The secondary analysis of feasibility and the experienced benefit of using the inhalation app-module in clinical practice and for patient's education and training of inhalation technique is estimated on a Likert scale from 1 (not at all) to 5 (strongly agree) and presented as mean and median scores.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• Subjects, age \>16 years, willing to voluntarily participate in the study and give electronic written informed consent through BankID or similar service, with daily inhalation therapy through DPI and/or MDI for doctor's diagnosed asthma or COPD.

Locations
Other Locations
Sweden
Healthcare Centre
RECRUITING
Boxholm
Healthcare centre
RECRUITING
Styrsö
Uppsala University Hospital, Lung and Allergy Department
RECRUITING
Uppsala
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 80
Treatments
No_intervention: Standard care
The comparator is standard assessment and instructions of inhalation technique while healthcare personnel review patient using their inhaler (DPI or MDI) or similar training device without medication.
Experimental: Intervention
The potential clinical benefit of using an app-based approach for education and training of inhalation technique is to make the support more accessible for patients to use at home or whenever patients feel inhalation support is needed. Another potential benefit and novelty are the objective assessment of inhalation techniques regarding PIF, time to PIF and inspiration time, which is not possible to precisely assess in standard assessment of inhalation technique.
Sponsors
Leads: Karolinska Institutet
Collaborators: Uppsala University Hospital

This content was sourced from clinicaltrials.gov