Digital Self-Monitoring in Severe Asthma

January 30, 2026 updated by: Norbert Wellmann, University of Medicine and Pharmacy "Victor Babes" Timisoara

Effect of Digital Self-Monitoring on Patient Engagement and Clinical Outcomes in Severe Asthma: A Randomized Controlled Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Timiș County
      • Timișoara, Timiș County, Romania, 300310
        • Dr. Victor Babeș Clinical Hospital for Infectious Diseases and Pulmonology, Timișoara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group (Reminder)
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
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.
Active Comparator: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to telemedicine-based home monitoring
Time Frame: 12 weeks
Proportion of prescribed weekly home spirometry sessions successfully completed and transmitted via the AioCare system during the 12-week monitoring period.
12 weeks
Asthma control assessed by ACT
Time Frame: Baseline and 12 weeks
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.
Baseline and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported satisfaction and engagement with the telemonitoring system
Time Frame: 12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy "Victor Babes" Timisoara

Investigators

  • Principal Investigator: Norbert Wellmann, MD, Phd student, Victor Babes Hospital for Infectious and Pulmonary Diseases, Timisoara, Romania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

October 1, 2025

Study Completion (Actual)

October 1, 2025

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIOCARE-SEV-ASTHMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on AioCare home spirometry system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe