Digital Self-Monitoring in Severe Asthma

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.

Inclusion criteria

• Diagnosis of severe asthma according to GINA guidelines.
• Age ≥ 18 years.
• Ability to correctly perform spirometry maneuvers according to ATS/ERS standards after training.
• Access to a smartphone compatible with the AioCare application.
• Willingness to participate in weekly home-based spirometry monitoring and telemonitoring for three months.
• Stable maintenance asthma therapy for at least four weeks prior to enrollment.
• Ability and willingness to provide written informed consent.

Exclusion criteria

• Age < 18 years.
• Diagnosis of other significant respiratory diseases (including chronic obstructive pulmonary disease, interstitial lung disease, or bronchiectasis).
• Asthma exacerbation requiring hospitalization or systemic corticosteroids within the four weeks prior to enrollment.
• Severe psychiatric or cognitive impairment that could interfere with adherence to the monitoring protocol or ability to use the device independently.
• Inability to perform acceptable spirometry maneuvers despite training.
• Lack of smartphone or internet access required for AioCare telemonitoring.
• Pregnancy or breastfeeding.
• Refusal or inability to provide informed consent.