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

Information source: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Paper Asthma Action Plan (Other); Mobile Phone (Device)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Arkansas Children's Hospital Research Institute

Official(s) and/or principal investigator(s):
Tamara T Perry, MD,FAAP, Principal Investigator, Affiliation: University of Arkansas

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Asthma Control Test Score

Secondary outcome: Change in Asthma Self-Efficacy Score

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

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

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.

Locations and Contacts

Arkansas Children's Hospital Research Institute, Little Rock, Arkansas 72202, United States
Additional Information

Related publications:

Moorman JE, Rudd RA, Johnson CA, King M, Minor P, Bailey C, Scalia MR, Akinbami LJ; Centers for Disease Control and Prevention (CDC). National surveillance for asthma--United States, 1980-2004. MMWR Surveill Summ. 2007 Oct 19;56(8):1-54.

Akinbami LJ, Moorman JE, Garbe PL, Sondik EJ. Status of childhood asthma in the United States, 1980-2007. Pediatrics. 2009 Mar;123 Suppl 3:S131-45. doi: 10.1542/peds.2008-2233C.

Forero R, Bauman A, Young L, Larkin P. Asthma prevalence and management in Australian adolescents: results from three community surveys. J Adolesc Health. 1992 Dec;13(8):707-12.

Kyngäs HA. Compliance of adolescents with asthma. Nurs Health Sci. 1999 Sep;1(3):195-202.

Braun-Fahrländer C, Gassner M, Grize L, Minder CE, Varonier HS, Vuille JC, Wüthrich B, Sennhauser FH. Comparison of responses to an asthma symptom questionnaire (ISAAC core questions) completed by adolescents and their parents. SCARPOL-Team. Swiss Study on Childhood Allergy and Respiratory Symptoms with respect to Air Pollution. Pediatr Pulmonol. 1998 Mar;25(3):159-66.

Venn A, Lewis S, Cooper M, Hill J, Britton J. Questionnaire study of effect of sex and age on the prevalence of wheeze and asthma in adolescence. BMJ. 1998 Jun 27;316(7149):1945-6.

Calmes D, Leake BD, Carlisle DM. Adverse asthma outcomes among children hospitalized with asthma in California. Pediatrics. 1998 May;101(5):845-50.

Starting date: March 2014
Last updated: June 22, 2015

Page last updated: August 23, 2015

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