Effect of a Daily Text Reminder on Asthma Medication Use, Symptom Control, and Lung Function in Children

ROXANA AZNARAN TORRES64 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Asthma in Children

Interventions

Eligibility

Sex: ALLMin age: 5 YearsMax age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Change in Inhaler Adherence as Measured by the Inhaler Adherence Scale for Children (IASC) at 45 and 90 Days

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.

Time frame: 45 days (T1) and 90 days (T2) after the intervention

Secondary Outcomes

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

Symptom control was assessed using the Asthma Control Test (ACT) for participants aged 12 years and older, and the Childhood Asthma Control Test (c-ACT) for children under 12 years old. The ACT consists of 5 questions regarding asthma symptoms, and the c-ACT includes 4 questions for the child and 3 for the caregiver. A higher score indicates better control over asthma symptoms.

Time frame: Day 45 and day 90 after the intervention

Change in Pulmonary Function as Measured by Spirometry at 90 Days

Pulmonary function was assessed using spirometry at 90 days (T2). This measure evaluates the participants' lung function by assessing key parameters such as Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC). A bronchodilator response (BDR) was defined as an increase of more than 10% in FEV₁ or FVC following the administration of 400 µg of inhaled salbutamol; responses below this threshold indicated absence of BDR. Pulmonary function was categorized into four groups: (1) normal baseline spirometry without BDR (considered the only normal pattern), (2) normal baseline spirometry with BDR, (3) obstructive pattern without BDR, and (4) obstructive pattern with BDR. Additionally, lung function impairment severity was classified using z-score values: \> -1.645 (normal), -1.65 to -2.5 (mild), -2.51 to -4 (moderate), and \< -4.1 (severe).

Time frame: Baseline and day 90 after the intervention