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

NCT02091869 | Completed Results

• 1 other identifier: 202623
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Adolescents; Asthma; Asthma Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Asthma Self-Efficacy Scores

  Baseline and Six months

Other Outcomes (1)

• Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans

  Six months

Study Arms (2)

Paper Asthma Action Plan

EXPERIMENTAL

Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.

Other: Paper Asthma Action Plan

Mobile Phone

EXPERIMENTAL

Participants will record asthma symptoms, medication usage, and peak flow data on their phones.

Device: Mobile Phone

Interventions

Paper Asthma Action Plan OTHER

Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage.

Paper Asthma Action Plan

Mobile Phone DEVICE

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

Also known as: IPhone and Android mobile phones

Mobile Phone

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead
• University of Arkansas: collaborator

Study Sites (1)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

Related Publications (8)

• 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.

  PMID: 17947969 BACKGROUND

• 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.

  PMID: 19221156 BACKGROUND

• 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. doi: 10.1016/1054-139x(92)90068-m.

  PMID: 1290773 BACKGROUND

• Kyngas HA. Compliance of adolescents with asthma. Nurs Health Sci. 1999 Sep;1(3):195-202. doi: 10.1046/j.1442-2018.1999.00025.x.

  PMID: 10894643 BACKGROUND

• Braun-Fahrlander C, Gassner M, Grize L, Minder CE, Varonier HS, Vuille JC, Wuthrich 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. doi: 10.1002/(sici)1099-0496(199803)25:33.0.co;2-h.

  PMID: 9556007 BACKGROUND

• 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. doi: 10.1136/bmj.316.7149.1945. No abstract available.

  PMID: 9641931 BACKGROUND

• Calmes D, Leake BD, Carlisle DM. Adverse asthma outcomes among children hospitalized with asthma in California. Pediatrics. 1998 May;101(5):845-50. doi: 10.1542/peds.101.5.845.

  PMID: 9565412 BACKGROUND

• 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.

  PMID: 28111110 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

There were not limitations and caveats.

Results Point of Contact

• Title: Dr. Tamara T. Perry
• Organization: University of Arkansas for Medical Sciences

perrytamarat@uams.edu

501-364-1538

Study Officials

• Tamara T Perry, MD,FAAP

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: March 19, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 29, 2018
• Results First Posted: February 23, 2017

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)