An interventional study of AioCare home spirometry system in Severe Asthma and Asthma, sponsored by University of Medicine and Pharmacy "Victor Babes" Timisoara. Completed at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by University of Medicine and Pharmacy "Victor Babes" Timisoara · Not applicable, Interventional, and Other
This randomized controlled pilot study aimed to assess adherence to telemedicine-based home monitoring using the AioCare digital respiratory system in adults with severe asthma over a three-month period and to determine whether weekly reminder messages sent via SMS or through the AioCare platform enhanced adherence compared with standard remote monitoring.
The study was conducted at a single center in Timișoara, Romania, between October 2024 and October 2025. Thirty adult patients with severe asthma were randomized 1:1 to either an intervention group receiving weekly reminders via SMS or in-app notifications, or a control group without reminders. All participants performed weekly home spirometry for 12 weeks using the AioCare system.
The primary objective of the study was to assess adherence to telemedicine-based home monitoring over the three-month period and to evaluate the effect of weekly reminder messages on adherence compared with standard remote monitoring.
The study found that patients who received reminder messages demonstrated higher adherence to home monitoring compared with those who did not receive reminders. No device-related adverse events were reported.
This study investigated telemedicine-based home monitoring in adults with severe asthma using the AioCare digital respiratory system in a real-world clinical setting.
Participants were equipped with a portable AioCare spirometry device and trained to use the associated mobile application for home measurements. The system enabled wireless transmission of spirometric data to a secure cloud-based platform, allowing remote review of patient-generated data by the study team.
After enrollment and training, patients performed regular home spirometry over a three-month monitoring period. Measurements were conducted in the patients' home environment and automatically uploaded through the AioCare platform. Data quality was assessed according to international acceptability and repeatability criteria.
One study group additionally received automated weekly reminder messages delivered via SMS or through the AioCare application, depending on technical availability and patient preference. These reminders were standardized and intended to support regular performance of home measurements. The comparator group used the same monitoring system without reminders.
Throughout the study, participants continued their usual standard-of-care treatment. No experimental medications or therapeutic interventions were introduced. Study procedures focused on remote data collection, monitoring feasibility, and patient interaction with the digital health system.
At the end of the monitoring period, patient-reported questionnaires were administered to document user experience with the telemonitoring system. Safety was monitored throughout the study, with specific attention to device-related adverse events.
3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 30 is below the median of 83 across 2,751 interventional studies indexed under Asthma.
Browse Asthma studies →University of Medicine and Pharmacy "Victor Babes" Timisoara is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Adults with severe asthma who used the AioCare digital respiratory system for home spirometry and received weekly reminder messages via SMS or in-app notifications to support adherence.
Device: AioCare home spirometry system
Adults with severe asthma who used the AioCare digital respiratory system for home spirometry without receiving reminder messages (standard remote monitoring).
Device: AioCare home spirometry system
The AioCare digital respiratory system was used to perform weekly home spirometry and to transmit lung function data to a secure telemedicine platform for remote monitoring by the study team.
Adherence to telemedicine-based home monitoring
Proportion of prescribed weekly home spirometry sessions successfully completed and transmitted via the AioCare system during the 12-week monitoring period.
Time frame: 12 weeks
Asthma control assessed by ACT
Change in Asthma Control Test (ACT) score from baseline to week 12. The ACT is a validated 5-item questionnaire, with scores ranging from 5 to 25, where higher scores indicate better asthma control. Scores ≥20 indicate well-controlled asthma, 16-19 partially controlled, and ≤15 poorly controlled. A change of ≥3 points is considered clinically meaningful.
Time frame: Baseline and 12 weeks
Patient-reported satisfaction and engagement with the telemonitoring system
Patient-reported satisfaction and engagement will be assessed at the end of the 12-week study period using an adapted version of the mHealth App Usability Questionnaire (MAUQ). The instrument includes 10 dichotomous (Yes/No) items. Responses are coded as Yes = 1 and No = 0 and summed to generate a total score ranging from 0 to 10. Higher scores indicate greater satisfaction, perceived usefulness, and engagement with the telemedicine-based home monitoring system.
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University of Medicine and Pharmacy "Victor Babes" Timisoara