Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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The proposed project aligns with our prior work targeting high-risk pediatric asthma populations in non-inner city environments by targeting adolescents at risk for future exacerbations from the Patient-Centered Medical Home (PCMH) at Arkansas Children's Hospital (ACH). We propose to conduct a 3-arm randomized, controlled trial with 372 adolescents with uncontrolled asthma to test the effectiveness of mAAP. mAAP provides real-time, personalized feedback, asthma education, and data logging/tracking capabilities.

Official Title
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Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients

Conditions
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Pediatric Asthma

Intervention / Treatment
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* Behavioral: PEAKmAAP
* Behavioral: PEAKmAAP-DS
* Behavioral: NutriMap Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will conduct a randomized, controlled trial of 372 adolescents with uncontrolled mild-severe persistent asthma to examine the effectiveness of a personalized, interactive PEAKmAAP application with and without PCP data sharing in reducing asthma morbidity. The trial includes 3 groups: 1) a group utilizing the PEAKmAAP alone, 2) a group utilizing the PEAKmAAP with PCP data sharing (PEAKmAAP-DS), and 3) a usual care NutriMapgroup utilizing an application with daily non-asthma related reminders for attention control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PEAKmAAP<br>The Pulmonary Education and Asthma Knowledge mobile asthma action plan (PEAKmAAP) group will use a mobile app that will help manage asthma. Participants will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. mAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification. | Behavioral: PEAKmAAP<br>* The PEAKmAAP group will use a mobile app that will help manage asthma.<br>|
| Other: PEAKmAAP-Data Sharing (DS)<br>PEAKmAAP with Data Sharing (PEAKmAAP-DS) group will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. PEAKmAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification. The primary care provided (PCP) will receive monthly reports to help them know how the participant's asthma symptoms are over time. | Behavioral: PEAKmAAP-DS<br>* This group will use the mobile app to help manage asthma. the primary care provider will receive monthly reports to help him/her know how the participants asthma symptoms are over time.<br>|
| Other: Nutrition Map (NutriMap) Usual Care<br>Participants in this arm will use a smartphone application that sends daily non-asthma-related reminder for attention control. Participants will be asked to log their daily fruits and vegetables eaten. Participants will answer survey questions about their asthma and symptoms management. | Behavioral: NutriMap Usual Care<br>* This group will use a non-asthma related app daily to record their daily intake of fruits and vegetables.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Asthma Control Test (ACT) Score | ACT is a validated five question survey that computes a number indicating asthma control. The instrument range is 1-25, with 25 indication well controlled asthma. A score of less than or equal 19 is considered poorly controlled asthma. We plan to prospectively assess clinical outcomes including (ACT) score, Composite Asthma Severity Index (CASI) score, acute healthcare utilization, medication use, and lung function. | 12 months | 
| Composite Asthma Severity Index (CASI) score | The CASI quantify disease severity by looking at impairment risk and the amount of medication needed to maintain control. The CASI includes the major domains of asthma namely, impairment, as measured by day and night symptoms, along with albuterol use; and risk measured by forced expiratory volume in one second (FEV1) percent predicted and past asthma exacerbations, both of which are important predictors of future exacerbations. | 12 months | 
| Healthcare Utilization | We plan to utilize the PedsQOL instrument to measure participant quality of life. The PedQOL is a modular approach to measuring health related quality of life in children and adolescents with acute chronic health conditions. The instrument has a disease specific module for asthma. The instrument access four scales: physical functioning, emotional functioning, social functioning and school functioning. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mediators of Asthma Control | Medication adherence and asthma self-efficacy. Pharmacy profiles will be accessed to determine medication adherence. We plan to administer the Pediatric Quality of Life (PedsQOL) to determine asthma self-efficacy. We plan to evaluate if participants are more likely to receive step up therapy per the national asthma guidelines. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma Action Plan, Smartphone App