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

NCT ID: NCT02091869

Last Updated: 2018-06-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paper Asthma Action Plan

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

Group Type EXPERIMENTAL

Paper Asthma Action Plan

Intervention Type OTHER

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

Mobile Phone

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

Group Type EXPERIMENTAL

Mobile Phone

Intervention Type DEVICE

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

Interventions

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Mobile Phone

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

Intervention Type DEVICE

Paper Asthma Action Plan

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

Intervention Type OTHER

Other Intervention Names

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IPhone and Android mobile phones

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas

OTHER

Sponsor Role collaborator

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tamara T Perry, MD,FAAP

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17947969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19221156 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1290773 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10894643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9556007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9641931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9565412 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28111110 (View on PubMed)

Other Identifiers

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202623

Identifier Type: -

Identifier Source: org_study_id

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