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Behavioral Intervention

No Access to Asma Guardian website/app for 6 months for Childhood Asthma

N/A

Recruiting

Led By Elizabeth Matsui, MD

Research Sponsored by University of Texas at Austin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will compare the use of a special asthma app called Asma Guardián for Hispanic/Latinx children with asthma to the usual care they receive.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves using an educational website/app rather than medication, direct side effects are not anticipated. However, there may be indirect consequences related to misinterpretation of information or technology-related issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Participant engagement with the Asthma Guardian website/app

Other outcome measures

Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM)

Asthma Control Test (ACT)

Asthma Exacerbation

+15 more

Trial Design

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,843 Previous Clinical Trials

47,817,106 Total Patients Enrolled

7 Trials studying Childhood Asthma

2,436 Patients Enrolled for Childhood Asthma

University of Texas at AustinLead Sponsor

353 Previous Clinical Trials

81,194 Total Patients Enrolled

Elizabeth Matsui, MDPrincipal InvestigatorUniversity of Texas at Austin

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients to participate in this medical study?

"The trial, currently seeking participants, was first listed on clinicaltrials.gov on March 26th of the year 2024 and most recently revised on April15th of the same year."

Answered by AI

What is the total number of participants enrolled in this clinical investigation?

"Indeed, the details on clinicaltrials.gov show that this trial is actively enrolling participants. Posted initially on March 26th, 2024 and last revised on April 15th, 2024, the study aims to recruit a total of 50 individuals from one designated site."

Answered by AI

Is this clinical trial open to individuals younger than 60 years of age?

"According to the study's eligibility requirements, participants must be between 5 and 12 years old to be considered for enrollment."

Answered by AI

Who is eligible to participate in this medical study?

"This research aims to enroll 50 children aged between 5 and 12 years with a history of asthma. Eligible participants should meet the subsequent requirements: Submission of dated and signed informed consent documents, Have a child within the age range specified, Employ long-term controller medication for managing asthma or adhere to NAEPP guidelines concerning persistent disease criteria, Experience nocturnal asthma symptoms at least thrice in the preceding month, Report an episode of oral steroid treatment due to asthma exacerbation within the past year, Identify as Mexican American or another Hispanic descent caregiver/parental figure whose child has received an official diagnosis of asthma from a healthcare provider. Poss"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Culturally Tailored Scalable Asthma Intervention for Hispanic Children (Asthma Guardian)

Elizabeth Matsui 2024. "A Culturally Tailored Scalable Asthma Intervention for Hispanic Children (Asthma Guardian)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05892302.