Effect of the Visual Reminder "AdhasText" on Adherence to Inhaled Corticosteroids, Symptom Control, and Pulmonary Function in Children With Asthma: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in Inhaler Adherence as Measured by the Inhaler Adherence Scale for Children (IASC) at 45 and 90 Days
研究概览
简要总结
The goal of this clinical trial is to learn if a daily text reminder ("AdhasText") can help children with asthma use their inhalers regularly, control their symptoms, and improve their lung function. The main questions it aims to answer are:
Does the daily text reminder improve adherence to inhaled corticosteroids in children with asthma? Does the text reminder help children with asthma control their symptoms better? Does the text reminder improve lung function in children with asthma?
Researchers will compare children who receive the daily text reminder with usual care to children who receive usual care (without the reminder) to see if the text reminder improves adherence, symptom control, and lung function.
Participants will:
Receive a daily text reminder or usual care (no reminder) for 90 days Complete questionnaires about their asthma symptoms at 45 and 90 days Have spirometry tests to measure lung function at the start of the study and 90 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5 to 14 years with a clinical diagnosis of asthma
- •Children who required initiation of treatment with a fixed and regular dose of inhaled corticosteroids
- •Mothers or caregivers who had a mobile phone capable of sending and receiving text messages
排除标准
- •Children with congenital heart disease
- •Children who were unable to perform baseline spirometry
- •Children who experienced at least one exacerbation during the pre-randomization period
研究组 & 干预措施
Daily Text Reminder (AdhasText)
Participants in this group will receive a daily text message reminder ("AdhasText") to encourage them to use their inhalers regularly for 90 days. They will continue with their regular asthma management as prescribed by their healthcare providers.
干预措施: Daily Text Reminder (Behavioral)
Usual care
Participants in this group will receive the usual care for asthma, which does not include the daily text message reminders. They will continue with their regular asthma management as prescribed by their healthcare providers.
结局指标
主要结局
Change in Inhaler Adherence as Measured by the Inhaler Adherence Scale for Children (IASC) at 45 and 90 Days
时间窗: 45 days (T1) and 90 days (T2) after the intervention
Inhaler adherence was measured using the Inhaler Adherence Scale for Children (IASC), which evaluates adherence across three domains: Cognitive, Psychosocial, and Control \& Autonomy. The scale consists of 12 questions, with responses ranging from 0 (indicating poor adherence) to 4 (indicating full adherence) for each question. A higher total score indicates better adherence.
次要结局
- Change in Asthma Symptom Control as Measured by the ACT (Asthma Control Test) and c-ACT (Childhood Asthma Control Test) at 45 and 90 Days(Day 45 and day 90 after the intervention)
- Change in Pulmonary Function as Measured by Spirometry at 90 Days(Baseline and day 90 after the intervention)
研究者
ROXANA AZNARAN TORRES
Principal investigator, MD, PhD
Universidad Privada Antenor Orrego