Effect of Digital Self-Monitoring on Patient Engagement and Clinical Outcomes in Severe Asthma: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adherence to telemedicine-based home monitoring
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: AioCare home spirometry system (Device)
Control group
Adults with severe asthma who used the AioCare digital respiratory system for home spirometry without receiving reminder messages (standard remote monitoring).
干预措施: AioCare home spirometry system (Device)
结局指标
主要结局
Adherence to telemedicine-based home monitoring
时间窗: 12 weeks
Proportion of prescribed weekly home spirometry sessions successfully completed and transmitted via the AioCare system during the 12-week monitoring period.
Asthma control assessed by ACT
时间窗: 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.
次要结局
未报告次要终点
研究者
Norbert Wellmann
MD, Pulmonology Resident, PhD Student
University of Medicine and Pharmacy "Victor Babes" Timisoara