A Pilot and Feasibility Study of Mobile-Based Asthma Action Plans

This study has been completed.
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01514760
First received: January 18, 2012
Last updated: June 20, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention
Asthma
Other: Mobile-based Asthma Action Plan

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot and Feasibility Study of Mobile-Based Asthma Action Plans

Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • Mobile Asthma Action Plan (AAP) Usage [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    Median number of days per week (range 0-7) the Asthma Action Plan was utilized to record routine (daily) symptoms or peak flow measurements.


Secondary Outcome Measures:
  • Number of Participants That Utilized the Asthma Action Plan [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    The frequency of utilization of the Asthma Action Plan for acute symptoms among the study population will be measured and compared to responses of daily prompts that will ask participants to record whether they used rescue medication.

  • Asthma Self-Efficacy for Adolescent Children [ Time Frame: Baseline and eight weeks ] [ Designated as safety issue: No ]
    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 higher score represent a greater degree of self-efficacy. The Cronbach's α reliability = 0.75. The child self-efficacy questionnaire will be administered at baseline (pre-intervention) and at the end of the intervention (post-intervention).

  • Asthma Control Test™ Scores [ Time Frame: Baseline and eight weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 22
Study Start Date: June 2012
Study Completion Date: October 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mobile-based Asthma Action Plan
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
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.

Detailed Description:
A written Asthma Action Plan from a healthcare provider is one of the key features of asthma self-management recommended by the National Asthma Education and Prevention Program asthma guidelines; guidelines-based asthma care has not yet fully translated to the community despite the fact that National Asthma Education and Prevention Program released the first set of national guidelines nearly 2 decades ago. Previous reports have proven that patients with an Asthma Action Plan have better outcomes including fewer acute healthcare utilization visits, fewer days missed from school, and improved symptoms scores compared to patients without an Asthma Action Plan. Recently, mobile-based phone applications and music file (MPEG layer 3)(MP3) players have been utilized in the management of chronic diseases such as asthma and diabetes to provide medication reminders and to provide alternatives to paper dairies for logging symptoms or other health-related data such as peak flow readings or blood glucose readings. We propose to design an application that will fully meet the recommended individualized Asthma Action Plan treatment plan as recommended by national guidelines and will also provide participants with medication reminders, education tips, and data logging/tracking capabilities.
  Eligibility

Ages Eligible for Study:   12 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514760

Locations
United States, Arkansas
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
University of Arkansas
Investigators
Principal Investigator: Tamara T. Perry, M.D. University of Arkansas
  More Information

Publications:
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.

Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01514760     History of Changes
Other Study ID Numbers: 133343 
Study First Received: January 18, 2012
Results First Received: January 27, 2014
Last Updated: June 20, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:
Adolescents
Mobile based applications
Asthma action plan
Self Efficacy

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 21, 2016