NCT01514760

Brief Summary

Investigators from University of Arkansas for Medical Sciences Department of Pediatrics and University of Arkansas for Medical Sciences Center for Distance Health will collaborate to develop a mobile-based Asthma Action Plan application to improve asthma self-management skills specifically targeting adolescents. The investigators hypothesize that an interactive, mobile-based asthma action plan will be a feasible means of reinforcing long-term asthma management guidelines as well as delivering acute management instructions to adolescents with asthma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

February 18, 2016

Completed
Last Updated

October 11, 2017

Status Verified

September 1, 2017

Enrollment Period

4 months

First QC Date

January 18, 2012

Results QC Date

January 27, 2014

Last Update Submit

September 11, 2017

Conditions

Asthma

Keywords

AdolescentsMobile based applicationsAsthma action planSelf Efficacy

Outcome Measures

Primary Outcomes (1)

  • Mobile Asthma Action Plan (AAP) Usage

    Median number of days per week (range 0-7) the Asthma Action Plan was utilized to record routine (daily) symptoms or peak flow measurements.

    Eight weeks

Secondary Outcomes (3)

  • Number of Participants That Utilized the Asthma Action Plan

    Eight weeks

  • Asthma Self-Efficacy for Adolescent Children

    Baseline and eight weeks

  • Asthma Control Test™ Scores

    Baseline and eight weeks

Study Arms (1)

Mobile-based Asthma Action Plan

EXPERIMENTAL

The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.

Other: Mobile-based Asthma Action Plan

Interventions

Mobile-based Asthma Action PlanOTHER

The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth "rotating" message will be sent twice weekly.

Mobile-based Asthma Action Plan

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age ≥ 12 and ≤ 17 years.
  • Mild to severe persistent asthma or poorly controlled asthma. 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: We will assess for mild persistent to severe persistent asthma. Any one of the following, during the prior 4 weeks (as defined by parent interview) 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: We will 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.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

Related Publications (10)

  • 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: 17947969BACKGROUND

  • 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: 19221156BACKGROUND

  • 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: 1290773BACKGROUND

  • 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: 10894643BACKGROUND

  • 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: 9556007BACKGROUND

  • 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: 9641931BACKGROUND

  • National asthma education and prevention program expert panel report 3: Guidelines for the Diagnosis and Management of Asthma. National Heart Lunch and Blood Institute. 2007:NIH Publication No. 07-4051.

    BACKGROUND

  • Anhoj J, Moldrup C. Feasibility of collecting diary data from asthma patients through mobile phones and SMS (short message service): response rate analysis and focus group evaluation from a pilot study. J Med Internet Res. 2004 Dec 2;6(4):e42. doi: 10.2196/jmir.6.4.e42.

    PMID: 15631966BACKGROUND

  • Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.

    PMID: 14713908BACKGROUND

  • Mosnaim GS, Cohen MS, Rhoads CH, Rittner SS, Powell LH. Use of MP3 players to increase asthma knowledge in inner-city African-American adolescents. Int J Behav Med. 2008;15(4):341-6. doi: 10.1080/10705500802365656.

    PMID: 19005935BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Limitations and Caveats

There are no limitations/caveats to report.

Results Point of Contact

Title
Dr. Tamara T. Perry
Organization
University of Arkansas for Medical Sciences
perrytamarat@uams.edu
501-364-3264

Study Officials

  • Tamara T. Perry, M.D.

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 23, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2013

Last Updated

October 11, 2017

Results First Posted

February 18, 2016

Record last verified: 2017-09

Locations

US(1)