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N/A Completed N=34 Randomized Treatment

A Randomized Trial Examining the Effectiveness of Mobile-Based Asthma Action Plans vs. Paper Asthma Action Plans

Source: ClinicalTrials.gov NCT02091869 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Change in Asthma Control Test Scores — 21; 22; 20; 21 units on a scale

Summary

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Asthma Control Test Scores
21; 22; 20; 21 —
SECONDARY
Change in Asthma Self-Efficacy Scores
36; 34; 35; 35; 25; 27 —

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02091869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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