Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients (NCT03842033) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients
United States370 participantsStarted 2019-03-04
Plain-language summary
The goal of this research study is to test how good an app is in making asthma easier to manage for 372 adolescents/young adults. The app is a mobile version of the asthma action plan.
Who can participate
Age range
12 Years – 20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥12 and \<21 years
* Persistent asthma according to national guidelines criteria
* Asthma Control Test (ACT) score ≤19
* Prescribed a preventive (controller) asthma medication in the past 6 months
* Access to a smartphone compatible with the PEAKmAAP and NutriMap
* Access to the internet
* Able to read and speak English
Exclusion Criteria:
* Significant underlying respiratory disease other than asthma, such as cystic fibrosis
* Significant co-morbid conditions, such as moderate to severe developmental delay that could interfere with the adolescent's ability to self-monitor asthma
* Current smoker
* Participation in the investigator's or other asthma clinical trials in the previous 6 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on high-risk pediatric asthma patients using a mobile health app — can you tell me whether my child's asthma severity actually qualifies as 'high risk' by the standards this study is using?
2The trial is measuring changes in Asthma Control Test scores as its main outcome — how would you expect my child's current ACT score to compare to what this intervention is trying to improve, and is that a meaningful goal for us right now?
3Since this study is listed as 'active, not recruiting,' does that mean enrollment is closed, and if so, are there similar m-health or app-based asthma management programs we could access outside of this trial?
4This appears to be a guidelines-based mobile health intervention rather than a drug or device trial — what does that mean in terms of safety, and how does it differ from what we're already doing to manage my child's asthma at home?
5Are there standard-of-care asthma management tools or programs that offer similar benefits to what this trial is testing, so we can discuss whether a research study is even necessary compared to existing options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Asthma Control Test (ACT) Score
Timeframe: 3 months
Trial details
NCT IDNCT03842033
SponsorArkansas Children's Hospital Research Institute