50 Participants Needed

Asma Guardian App for Childhood Asthma

SB
CV
Overseen ByChristian Vallejo, MS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas at Austin
Must be taking: Long-term controllers
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This is a two-arm, parallel design, randomized, controlled pilot trial comparing access to Asma Guardián, a culturally tailored multi-component app-based asthma intervention for Hispanic/Latinx school age children with asthma, to usual care.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems likely that children can continue their current asthma treatments while participating.

What data supports the effectiveness of the treatment Asma Guardian App for Childhood Asthma?

Research on similar mobile health apps for asthma shows they can help children manage their asthma better, leading to fewer symptoms and improved quality of life. For example, the Blue Angel program improved asthma symptoms and increased adherence to treatment plans in children.12345

Is the Asma Guardian App safe for use in children with asthma?

The Asma Guardian App, tested under different names, has been used in studies with children and young people with asthma. These studies focused on usability and engagement, and no safety concerns were reported during the testing phases.678910

What makes the Asma Guardian treatment unique for childhood asthma?

The Asma Guardian app is unique because it is designed specifically for children aged 0-12 years and their caregivers, focusing on interactions between them to support asthma self-management. Unlike other treatments, it provides tailored feedback and uses engaging features like animated graphics to help children understand and manage their asthma effectively.26101112

Research Team

EM

Elizabeth Matsui, MD

Principal Investigator

University of Texas at Austin

Eligibility Criteria

This trial is for Hispanic/Latinx parents with a child aged 5-12 who has asthma, uses long-term control medication, or meets criteria for persistent disease. The child must have had nocturnal symptoms and an exacerbation in the past year. Families need tech access for the app-based study but can't join if involved in another asthma study.

Inclusion Criteria

Provision of signed and dated informed consent forms
I am a parent with a child aged 5-12.
My child has persistent asthma, is Hispanic, and we have the tech for a study. We're not in another asthma study.

Exclusion Criteria

Unwilling to provide consent for research activities
I am able to understand and give consent for my treatment.
My child was intubated due to asthma.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive immediate access to the Asma Guardian app for asthma management, education, and environmental intervention for 6 months

6 months
Regular virtual interactions with a community health worker

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of asthma symptoms and app engagement

6 months
6 month follow-up visit

Delayed Access

Participants initially without access receive 1 month of access to the Asma Guardian app after the 6-month study visit

1 month

Treatment Details

Interventions

  • Asma Guardian
Trial Overview The Asthma Guardian trial tests a culturally tailored app designed to help manage childhood asthma against usual care. Participants are randomly assigned to either get immediate access to the Asma Guardian app or receive delayed access after the study period.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: No Access to Asma Guardian website/app for 6 monthsExperimental Treatment1 Intervention
Note: Participants who are randomized to no access will not receive access during the 6 months of the study; however they will receive 1 month of access after their 6 month study visit but any information gained during this time will not be part of analysis.
Group II: Access to Asma Guardian website/appActive Control1 Intervention
Participants who are randomized to the Asma Guardian website at their baseline visit will have access to the website for 6 months starting at baseline. Access will be turned off at 6 months.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials
387
Recruited
86,100+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Findings from Research

The electronic-AsthmaTracker (e-AT) significantly improved asthma control and quality of life for children with asthma, as evidenced by reduced missed school days and increased parental satisfaction over a year-long study involving 327 participants.
Participants using e-AT experienced a 32% reduction in emergency department and hospital admissions and a 26% decrease in oral corticosteroid use compared to pre-intervention rates, and they had significantly better outcomes than matched controls.
Ambulatory Management of Childhood Asthma Using a Novel Self-management Application.Nkoy, FL., Fassl, BA., Wilkins, VL., et al.[2019]
The feasibility study of a mobile health app designed for children aged 0-12 years with asthma showed generally good acceptance, with 60% of caregivers and 63% of children reporting positive evaluations of the app's features after 6 months.
The most utilized feature was the 'record' function, but challenges in app usage were identified, indicating the need for ongoing improvements to enhance user experience and maintain engagement over time.
Development and Feasibility of a Mobile Asthma App for Children and Their Caregivers: Mixed Methods Study.Iio, M., Sato, M., Narita, M., et al.[2022]
The ASTHMAXcel Adventures mobile app significantly improved asthma control in pediatric patients, with controlled asthma rates increasing from 30.8% at baseline to 59.0% at 6 months, particularly among boys.
Patients experienced reduced emergency department visits and oral prednisone use, with a decrease from 0.46 visits at baseline to 0.02 visits at 6 months, indicating better overall asthma management and high patient satisfaction throughout the study.
Developing and evaluating ASTHMAXcel adventures: A novel gamified mobile application for pediatric patients with asthma.Hsia, BC., Singh, AK., Njeze, O., et al.[2020]

References

Ambulatory Management of Childhood Asthma Using a Novel Self-management Application. [2019]
Development and Feasibility of a Mobile Asthma App for Children and Their Caregivers: Mixed Methods Study. [2022]
Developing and evaluating ASTHMAXcel adventures: A novel gamified mobile application for pediatric patients with asthma. [2020]
The effectiveness of one-on-one nurse education on the outcomes of high-risk adult and pediatric patients with asthma. [2019]
An internet-based interactive telemonitoring system for improving childhood asthma outcomes in Taiwan. [2007]
Feasibility of a Secure Wireless Sensing Smartwatch Application for the Self-Management of Pediatric Asthma. [2019]
A Cell-Phone Medication Error eHealth App for Managing Safety in Chronically Ill Young Patients at Home: A Prospective Study. [2023]
Dose Matters: A Smartphone Application to Improve Asthma Control Among Patients at an Urban Pediatric Primary Care Clinic. [2020]
"Kiss myAsthma": Using a participatory design approach to develop a self-management app with young people with asthma. [2019]
A consumer designed smartphone app for young people with asthma: pilot of engagement and acceptability. [2021]
Beneficial Features of a mHealth Asthma App for Children and Caregivers: Qualitative Study. [2021]
Effective German and English Language mHealth Apps for Self-management of Bronchial Asthma in Children and Adolescents: Comparison Study. [2021]
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