NCT07053839

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
Last Updated

July 8, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

June 27, 2025

Last Update Submit

June 27, 2025

Conditions

Keywords

Text messageasthmatreatment adherencesymptom controlspirometrychildren

Outcome Measures

Primary Outcomes (1)

  • 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.

    45 days (T1) and 90 days (T2) after the intervention

Secondary Outcomes (2)

  • 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

Study Arms (2)

Daily Text Reminder (AdhasText)

EXPERIMENTAL

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.

Behavioral: Daily Text Reminder

Usual care

NO INTERVENTION

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.

Interventions

The intervention, titled "AdhasText," involved sending a daily SMS reminder to caregivers, specifically mothers of children with asthma. The message, "If you want to stay healthy, you must use your inhaler," was sent at 7:00 p.m. over a 90 days period.

Daily Text Reminder (AdhasText)

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Regional Docente de Trujillo

Trujillo, La Libertad, 20230, Peru

Location

Related Publications (5)

  • Jeminiwa R, Hohmann L, Qian J, Garza K, Hansen R, Fox BI. Impact of eHealth on medication adherence among patients with asthma: A systematic review and meta-analysis. Respir Med. 2019 Mar;149:59-68. doi: 10.1016/j.rmed.2019.02.011. Epub 2019 Feb 15.

    PMID: 30803887BACKGROUND
  • Chan AH, Stewart AW, Harrison J, Camargo CA Jr, Black PN, Mitchell EA. The effect of an electronic monitoring device with audiovisual reminder function on adherence to inhaled corticosteroids and school attendance in children with asthma: a randomised controlled trial. Lancet Respir Med. 2015 Mar;3(3):210-9. doi: 10.1016/S2213-2600(15)00008-9. Epub 2015 Jan 21.

    PMID: 25617215BACKGROUND
  • Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.

    PMID: 22743675BACKGROUND
  • Morton RW, Everard ML, Elphick HE. Adherence in childhood asthma: the elephant in the room. Arch Dis Child. 2014 Oct;99(10):949-53. doi: 10.1136/archdischild-2014-306243. Epub 2014 May 29.

    PMID: 24876303BACKGROUND
  • Papi A, Brightling C, Pedersen SE, Reddel HK. Asthma. Lancet. 2018 Feb 24;391(10122):783-800. doi: 10.1016/S0140-6736(17)33311-1. Epub 2017 Dec 19.

    PMID: 29273246BACKGROUND

MeSH Terms

Conditions

AsthmaTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator, MD, PhD

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 8, 2025

Study Start

July 22, 2023

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

July 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

The informed consent signed by participants does not include authorization to share individual-level data with external researchers.

Locations