NCT07393984Completed
Digital Self-Monitoring in Severe Asthma
Effect of Digital Self-Monitoring on Patient Engagement and Clinical Outcomes in Severe Asthma: A Randomized Controlled Pilot Study
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 25 Jan 2026
- Start date
- 1 Oct 2024
- Primary completion date
- 1 Oct 2025
- Lead sponsor
- University of Medicine and Pharmacy "Victor Babes" Timisoara
- Diseases
- Asthma
- NCT number
- NCT07393984
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 1 Oct 2024 to the primary completion date, 1 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Asthma exacerbation requiring hospitalization or systemic corticosteroids within the four weeks prior to enrollment.
Other illness
- Diagnosis of other significant respiratory diseases (including chronic obstructive pulmonary disease, interstitial lung disease, or bronchiectasis).
- Severe psychiatric or cognitive impairment that could interfere with adherence to the monitoring protocol or ability to use the device independently.
Age
- Age \< 18 years.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Victor Babeș Clinical Hospital for Infectious Diseases and Pulmonology, Timișoara Coordinator of this site? Confirm its status | Timișoara | Romania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.