AzTrials
AzTrials

Asthma in ChildrenNCT07053839

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

A study testing Daily Text Reminder in people with Asthma in Children, run by ROXANA AZNARAN TORRES at 1 site in Peru.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 5 to 14 years
Conditions the study is for
Asthma in Children
What is being tested?
Daily Text Reminder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 sitePeru
Study dates
22 Jul 2023to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Peru1 site

  • Hospital Regional Docente de Trujillo

    Trujillo, La Libertad, 20230

Other trials in Peru

About this study

Official title: Effect of the Visual Reminder "AdhasText" on Adherence to Inhaled Corticosteroids, Symptom Control, and Pulmonary Function in Children With Asthma: A Randomized Clinical Trial

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?

Read more

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

Being tested
Daily Text Reminder
Keywords
Text message, asthma, treatment adherence, symptom control, spirometry, children
Medical subject headings
Asthma, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daily Text ReminderBehavioural

    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.

Study groups in NCT07053839
Study groupRoleWhat they receive
Daily Text Reminder (AdhasText)ExperimentalParticipants 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.
Receives: Behavioral: Daily Text Reminder
Usual careNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

  1. 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.

    Measured: Day 45 and day 90 after the intervention

  2. 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).

    Measured: Baseline and day 90 after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2025
  2. Study start22 Jul 2023
  3. Primary completion30 Sep 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07053839
Sponsor's protocol ID
0726-2023-UPAO
Other IDs
0422-2023-D-EPG-UPAO
Status last verified
Jun 2025
First submitted
27 Jun 2025
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The informed consent signed by participants does not include authorization to share individual-level data with external researchers.

Publications

  • 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.

    PubMed 30803887

  • 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.

    PubMed 25617215

  • 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.

    PubMed 22743675

  • 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.

    PubMed 24876303

  • 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.

    PubMed 29273246

Questions about this trial

What is this clinical trial studying?

A study testing Daily Text Reminder in people with Asthma in Children, run by ROXANA AZNARAN TORRES at 1 site in Peru.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Inhaler Adherence as Measured by the Inhaler Adherence Scale for Children (IASC) at 45 and 90 Days (time frame: 45 days (T1) and 90 days (T2) after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07053839, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in