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

Asthma Clinical Trial

— PEAK2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091869
• Other study ID #: 202623
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: April 2015

Study information

• Verified date: June 2018
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Paper Asthma Action Plan
Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage.

Device:
• Mobile Phone
Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app.

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute	University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans	We measured the participant usage rates by frequency of a mobile asthma action plan compared to usage rates of a paper asthma action plan. No mobile usage data was collected for the paper asthma plan group; and no paper usage data was collected for mobile phone group.	Six months
Primary	Change in Asthma Control Test Scores	The Asthma Control Test™ (ACT) is a 5 question health survey used to measure asthma control in individuals 12 years of age and older. The total sum scores range from 5-25. Higher scores mean that asthma is more controlled. The ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. ACT helps identify and detect asthma patients who are not well controlled. ACT scores were examined pre- and post-intervention. A score total of 19 or less means asthma may not be well controlled. The timeframe is during the past 4 weeks. The scale range for Question 1 is "all the time" (1) to "none of the time" (5); Question 2 range: "more than once a day" (1) to "not at all" (5); Question 3 range: "4 or more nights a week" (1) to "not at all" (5); Question 4 range: "3 or more times per day" (1) to "not at all" (5); Question 5 range: "not controlled at all" (1) to "completely controlled" (5).	Baseline and Six months
Secondary	Change in Asthma Self-Efficacy Scores	The Child Self-Efficacy instrument is a 14 item validated questionnaire designed to measure the child's self-efficacy with regard to attack prevention and attack management. The child will be required to select one of 5 responses ranging from "not at all sure" (1 point); "a little bit sure" (2 points); "fairly sure" (3 points); "quite sure" (4 points) to "completely sure" (5 points). Total score range from 14-70. The attack prevention scale range from 6-30 and attack management range from 8-40. The higher score represent a greater degree of self-efficacy. The Cronbach's a reliability = 0.75. The child self-efficacy questionnaire will be administered at baseline (pre-intervention) and at the end of the intervention (post-intervention).	Baseline and Six months