Clinical trial NCT01514760: A Pilot and Feasibility Study of Mobile-Based Asthma Action Plans
Official title: A Pilot and Feasibility Study of Mobile-Based Asthma Action Plans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Adolescents
Mobile based applications
Asthma action plan
Self Efficacy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: University of Arkansas
First posted: 2012-01-23
Enrollment: 22
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigators from University of Arkansas for Medical Sciences Department of Pediatrics and University of Arkansas for Medical Sciences Center for Distance Health will collaborate to develop a mobile-based Asthma Action Plan application to improve asthma self-management skills specifically targeting adolescents. The investigators hypothesize that an interactive, mobile-based asthma action plan will be a feasible means of reinforcing long-term asthma management guidelines as well as delivering acute management instructions to adolescents with asthma.

Detailed description: A written Asthma Action Plan from a healthcare provider is one of the key features of asthma self-management recommended by the National Asthma Education and Prevention Program asthma guidelines; guidelines-based asthma care has not yet fully translated to the community despite the fact that National Asthma Education and Prevention Program released the first set of national guidelines nearly 2 decades ago. Previous reports have proven that patients with an Asthma Action Plan have better outcomes including fewer acute healthcare utilization visits, fewer days missed from school, and improved symptoms scores compared to patients without an Asthma Action Plan. Recently, mobile-based phone applications and music file (MPEG layer 3)(MP3) players have been utilized in the management of chronic diseases such as asthma and diabetes to provide medication reminders and to provide alternatives to paper dairies for logging symptoms or other health-related data such as peak flow readings or blood glucose readings. We propose to design an application that will fully meet the recommended individualized Asthma Action Plan treatment plan as recommended by national guidelines and will also provide participants with medication reminders, education tips, and data logging/tracking capabilities.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 12 and ≤ 17 years.
* Mild to severe persistent asthma or poorly controlled asthma. If a child has used a preventive medication in the past, but reports no use of the medication in the prior 3 months, we will assess severity.
* Children not using a preventive medication at baseline: We will assess for mild persistent to severe persistent asthma. Any one of the following, during the prior 4 weeks (as defined by parent interview) will determine severity:
* An average of \>2 days per week with asthma symptoms
* \>2 days per week with rescue medication use
* ≥2 nights per month awakened with nighttime symptoms
* Minor limitation of activity
* ≥2 episodes of asthma during the past year that have required systemic corticosteroids.
* Children using a preventive medication at baseline: We will assess for poorly controlled asthma. Any 1 of the following, during the prior 4 weeks (as defined by parent interview in the waiting room) will determine control:
* An average of \>2 days per week with asthma symptoms
* \>2 days per week with rescue medication use
* ≥2 nights per month awakened with nighttime symptoms
* Some limitation of activity
* ≥2 episodes of asthma during the past year that have required systemic corticosteroids.

Exclusion Criteria:

* Significant underlying respiratory disease other than asthma (such as cystic fibrosis or chronic lung disease) that could potentially interfere with asthma-related outcome measures.
* Significant co-morbid conditions (such as moderate to severe developmental delay, i.e. special education classroom or diagnosis) that could preclude participation in an education-based intervention.
* Inability to speak or understand English (child or parent).
* Children in foster care or other situations in which consent cannot be obtained from a guardian.
* Prior enrollment in the study.

Primary outcomes:
measure: Mobile Asthma Action Plan (AAP) Usage
timeFrame: Eight weeks
Secondary outcomes:
measure: Number of Participants That Utilized the Asthma Action Plan
timeFrame: Eight weeks
measure: Asthma Self-Efficacy for Adolescent Children
timeFrame: Baseline and eight weeks
measure: Asthma Control Test™ Scores
timeFrame: Baseline and eight weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Tamara T. Perry, M.D.
role: PRINCIPAL_INVESTIGATOR
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