CompletedNot Applicable

Digital Self-Monitoring in Severe Asthma

Romania30 participantsStarted 2024-10-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Adherence to telemedicine-based home monitoring

Timeframe: 12 weeks

Asthma control assessed by ACT

Timeframe: Baseline and 12 weeks

Trial details

NCT IDNCT07393984

SponsorUniversity of Medicine and Pharmacy "Victor Babes" Timisoara

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-01