Clinical trial NCT02091869: A Randomized Trial Examining the Effectiveness of Mobile-Based Asthma Action Plans vs. Paper Asthma Action Plans
Official title: A Randomized Trial Examining the Effectiveness of Mobile-Based Asthma Action Plans vs. Paper Asthma Action Plans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Adolescents
Asthma
Asthma Symptoms
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: University of Arkansas
First posted: 2014-03-19
Enrollment: 34
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if using a mobile phone application asthma action plan will help improve asthma management.

Detailed description: The investigators propose to conduct a randomized trial to examine the effectiveness of a mobile-based Asthma Action Plan that will meet the national guidelines recommendation for individualized Asthma Action Plan treatment plans. The mobile app will provide immediate instructions and feedback once data is entered by the participants. This is an randomized trial which will be compared with an paper asthma action plan. Participants will be randomized through a statistical table. The mobile app will be password and Health Information Portability and Protection Act protected.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 12 and ≤ 17 years.
* Access to Apple or Android based smart phone
* Mild to severe persistent asthma or poorly controlled asthma (see definitions below).

  o A different assessment of eligibility will be performed depending on whether or not the parent reports use of a preventive asthma medication at baseline. This is consistent with 2007 National Asthma Education Prevention Program recommendations that make a strong distinction between classifying asthma severity (for children not using preventive medications) and assessing control (for children using preventive medications). 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: Assess for mild persistent to severe persistent asthma. Any 1 of the following, during the prior 4 weeks (as defined by parent interview in the waiting room) 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: 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: Change in Asthma Control Test Scores
timeFrame: Baseline and Six months
Secondary outcomes:
measure: Change in Asthma Self-Efficacy Scores
timeFrame: Baseline and Six months
Other outcomes:
measure: Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans
timeFrame: Six months
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, MD,FAAP
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Perry TT, Marshall A, Berlinski A, Rettiganti M, Brown RH, Randle SM, Luo C, Bian J. Smartphone-based vs paper-based asthma action plans for adolescents. Ann Allergy Asthma Immunol. 2017 Mar;118(3):298-303. doi: 10.1016/j.anai.2016.11.028. Epub 2017 Jan 19.