Pediatric Asthma
Conditions
Keywords
Asthma Action Plan, Smartphone App
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALPEAKmAAP
The PEAKmAAP group will use a mobile "app" that will help manage asthma.
BEHAVIORALPEAKmAAP-DS
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.
BEHAVIORALNutriMap Usual Care
This group will use a non-asthma related app daily to record their daily intake of fruits and vegetables.
Sponsors
Arkansas Children's Hospital Research Institute
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Asthma Control Test (ACT) Score | 3 months | The primary outcome measure will be the change from ACT score ≤19 (uncontrolled asthma) to ACT \>19 (controlled asthma) at 3 months. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mediators of Asthma Control | 12 months | 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). We plan to evaluate if participants are more likely to receive step up therapy per the national asthma guidelines. |
| Healthcare Utilization | 12 months | 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. |
| Change in Asthma Control Test (ACT) Score to Access Secondary Outcomes | 12 months | ACT a validated five question survey that computes a number indicating asthma control. The instrument range is 1-25, with 25 indicating 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. ACT scores may improve but remain ≤19 for participants with very poorly controlled asthma, we will assess for change in ACT score that is considered to be clinically important (as indicated by ≥3 point increase).The ACT score will be assessed via mobile survey to measure for sustained improvement throughout the study. We hypothesize that PCP data sharing will facilitate asthma control by alerting the PCP when asthma is worsening or failing to improve. The impact of PCP data sharing on ACT score will be measured to assess whether data sharing has added benefit to PEAKmAAP alone. |
| Composite Asthma Severity Index (CASI) score | 12 months | 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. |
| Asthma Control Classification | 12 months | Asthma guidelines categorize asthma control for individuals ≥12 years into 3 categories: well-controlled (WC), not well-controlled (NWC), or very poorly controlled (VPC). Asthma control is defined by the degree to which asthma manifestations are minimized by therapeutic intervention. Components of asthma control include measures of daytime symptoms, nighttime awakenings, activity limits, rescue medication use, and exacerbations requiring oral systemic corticosteroids. An assessment of asthma control will be made during the eligibility screening, at the in-person, structured interviews at baseline, 3 months and 12 months as well as via mobile survey at 6 and 9 months for all participants. |
| Lung Function and Airway Inflammation | 12 months | Spirometry is the test most used for the assessment of the risk for adverse events and impairment in asthma. Forced expiratory volume in the first second (FEV1) expressed as percent predictive of reference population value or as a proportion of the forced vital capacity (FEV1/FVC) will be assessed. FeNO is a quantitative, non-invasive measure of airway inflammation that predicts responsiveness and adherence to ICS. We will measure lung function and FeNO at baseline, 3 months, and 12 months for all participants. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTamara T. Perry, MD
University of Arkansas
Outcome results
None listed