Digital Self-Monitoring in Severe Asthma

NCT07393984 | Completed

• 1 other identifier: AIOCARE-SEV-ASTHMA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Asthma; Asthma

Keywords

Severe asthma; Telemedicine; Digital health; Home spirometry; Adherence; Patient engagement; Reminders; eHealth

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 12 weeks

Other Outcomes (1)

• Patient-reported satisfaction and engagement with the telemonitoring system

  12 weeks

Study Arms (2)

Intervention group (Reminder)

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

AioCare home spirometry system DEVICE

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.

Control group; Intervention group (Reminder)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy "Victor Babes" Timisoara: lead

Study Sites (1)

Dr. Victor Babeș Clinical Hospital for Infectious Diseases and Pulmonology, Timișoara

Timișoara, Timiș County, 300310, Romania

Location

MeSH Terms

Conditions

Asthma; Patient Participation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Norbert Wellmann, MD, Phd student

  Victor Babes Hospital for Infectious and Pulmonary Diseases, Timisoara, Romania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Pulmonology Resident, PhD Student

Model Details: This was a single-center, randomized, parallel-group pilot study. Participants were randomized in a 1:1 ratio to either an intervention group receiving weekly reminder messages via SMS or via the AioCare platform, or to a control group receiving standard telemedicine-based home monitoring without reminders.

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 6, 2026
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)