Asthma in Children Clinical Trial
Official title:
A Culturally Tailored Scalable Asthma Intervention for Hispanic Children
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | May 1, 2025 |
Est. primary completion date | April 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 12 Years |
Eligibility | Inclusion Criteria: 1. Provision of signed and dated informed consent forms. 2. Who has a child who is 5-12 years of age 3. Whose child meets criteria for current persistent asthma defined as either: 1. On a long-term controller medication for asthma, or 2. Meet NAEPP guideline requirements for persistent disease:)(35) - Asthma symptoms 3 or more days per week over the past 2 weeks OR - Nocturnal asthma symptoms at least 3 times in the past month 4. Whose child has had an asthma exacerbation, defined as an oral steroid burst, in the previous 12 months 5. Parent/Caregiver identifies as Mexican American or other Hispanic descent 6. Whose child has clinician diagnosed asthma 7. Access to necessary resources for participating in a technology-based intervention (i.e., computer, smart phone, internet access) 8. Whose child is not currently participating in another asthma study. The parent/caregiver is the primary study participant, but the child will be asked to complete some surveys at baseline and six months, so an assent will be obtained from the child. Exclusion Criteria: - An individual who meets any of the following criteria will be excluded from participation in this study: 1. Unwilling to provide consent for research activities 2. Cognitive inability to provide consent 3. Whose child has evidence of other chronic lung or significant cardiovascular disease 4. Whose child has a history of intubation for asthma |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas at Austin | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas at Austin | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Asthma Control Test (ACT) | Score range 5-25, higher score indicates better outcome. | 6 months follow-up visit | |
Other | Asthma Exacerbation | Defined as an oral steroid burst, measured as the number of bursts taken over the six month follow-up period | 6 months | |
Other | Asthma related acute care use | Measured by the number of hospitalizations, ER visits, or Unexpected Doctor visits over the six month follow-up period | 6 months | |
Other | Asthma controller medication | Measured by the number of days controller medication was taken in a 2 week period | 6 month follow-up visit | |
Other | Asthma controller medication treatment step | controller medication treatment step at the 6 month follow-up visit | 6 month follow-up visit | |
Other | Asthma symptoms | number of days of asthma symptoms in the previous 2 weeks | 6 month follow-up visit | |
Other | Asthma Specialty Visit | Defined as reporting at least one visit with an asthma specialist during the six month follow-up period | 6 months | |
Other | Short adapted Questionnaire to Measure Asthma Knowledge of Parents. | Measured using the Asthma Knowledge Questionnaire, sum of the scores for each question A Likert-type scale of 5 points is used. Items are graded '1', '2', '3', '4', and '5' for 'strongly disagree', 'disagree', 'neither agree, nor disagree', 'agree', and 'strongly agree', respectively.
Negative items are reverse coded by subtracting the responses values from 5. Missing answers of the asthma knowledge questionnaire scores a '3'. Total score is calculated by the sum of score item responses, ranging from 10 to 50, with higher scores indicating greater knowledge of asthma. |
6 months | |
Other | Pharmacy prescription data | Number of asthma controller medication prescription fills over the six month follow-up period | 6 months | |
Other | Use of the asthma control test | defined as the number of times the ACT form is downloaded from the app over the six month follow-up period | 6 months | |
Other | Request for home environmental supplies | Defined as the number of requests for home environmental supplies in the app over the six month time period | 6 months | |
Other | Deployment of home environmental supplies | Defined as report of deployment of any environmental supplies during the six month follow-up visits | 6 months | |
Other | Settled Dust allergen concentrations | Dust will be collected from pts and assayed for indoor allergens at six months and expressed in µg/g | 6 month follow-up visit | |
Other | Fine particulate matter (PM) | Defined as the average PM2.5 concentration during the six month follow-up period | 6 months | |
Other | Use of educational material | Defined as the number of times educational material is downloaded from the app over the six month follow-up period | 6 months | |
Other | Use of the App | Defined as the number of visits to the app over the six month time period | 6 months | |
Other | Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) | 4 item likert-scale validated survey, outcome will be expressed as the average score for the responses to the items at the 6 month follow-up visit. Response Scale:
1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scoring Instructions: Scales can be created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Higher score is a better outcome. |
6 month follow-up visit | |
Other | Number of interactions with the virtual Community Health Worker (CHW) | Described as the number of times pts interacted with the CHW over the six month follow up period | 6 months | |
Primary | Participant engagement with the Asthma Guardian website/app | Engagement is a composite outcome which is defined as engagement with at least 2 of the 3 toolkits. It will be expressed as the percentage of participants with engagement. Engagement with each of the toolkits is defined as follows:
(i) Asthma Specialist: at least one documented appointment with an asthma specialist; (ii) Asthma Management: Controller medication prescription fills covering at least 3 months of dosing; (iii) Home environment Toolkit: New deployment of at least some of the available environmental intervention materials, such as air purifiers. |
6 months |
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