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Online Asthma Self-Management for Children Aged 5-10 and Their Parents (ChildAsthma)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602392
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : November 11, 2015
Sponsor:
Information provided by (Responsible Party):
Susan Schroeder, Oregon Center for Applied Science, Inc.

Tracking Information
First Submitted Date  ICMJE May 31, 2013
First Posted Date  ICMJE November 11, 2015
Last Update Posted Date November 11, 2015
Study Start Date  ICMJE January 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2015)
  • Change from baseline in children's knowledge about asthma [ Time Frame: 45 days ]
    A 5-item knowledge scale was developed with program-specific questions regarding asthma physiology, response to worsening symptoms, and asthma medications. These items used a 3-response choice scheme: "true," "not true," and "I don't know." The total number of items correct was summed to form the knowledge scale.
  • Change from baseline in parents' knowledge about asthma [ Time Frame: 45 days ]
    The Parent Knowledge Questionnaire (alpha = .81; Mesters, et al., 2003) was adapted to match program content, creating a 19-item knowledge scale covering basic knowledge about asthma (e.g., response to worsening symptoms, asthma medications, asthma triggers). The total number of correct items was summed to form the knowledge scale.
  • Change from baseline in children's attitudes toward medication [ Time Frame: 45 days ]
    A 5-item knowledge scale was developed with program-specific questions regarding asthma physiology, response to worsening symptoms, and asthma medications. These items used a 3-response choice scheme: "true," "not true," and "I don't know." The total number of items correct was summed to form the knowledge scale.
  • Change from baseline in parents' attitudes about asthma self-management [ Time Frame: 45 days ]
    The Asthma Attitude Survey (Mesters, et al., 2003), adapted to fit program content, assessed parents' attitudes regarding recognition of worsening symptoms, asthma medications, and triggers management. A 5-point Likert-type scale ranging from 1 (strongly agree) to 5 (strongly disagree) was used for responses, and items were summed to create an overall attitudes score.
  • Change from baseline in children's self-efficacy to improve asthma self-management [ Time Frame: 45 days ]
    Three self-efficacy items addressed each child's confidence in being able to recognize warning signs, use his/her quick-relief medicine immediately when having warning signs, and take medications as directed. Response choices were presented on a Likert-type scale ranging from 1 (no way, I can't do that) to 4 (sure, I can do that).
  • Change from baseline in parents' self-efficacy to improve asthma self-management [ Time Frame: 45 days ]
    The Parent Asthma Self-Efficacy survey (Bursch, et al., 2003), adapted to fit program content, used a 5-point Likert-type scale ranging from 1 (not at all sure) to 5 (completely sure) to assess parents' confidence about administering medications and responding to worsening symptoms.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2015)
Change from baseline in Asthma Control Test [ Time Frame: 45 days ]
The Child-Asthma Control Test (C-ACT) for children 4-11 years old (Nathan, et al., 2004) was used to assess the child's current level of asthma control. The C-ACT contains 7 items-4 for the child's response and 3 for the parent's response, summed to create an asthma control score. Response choices for the children were presented on a 4-point Likert-type scale. The 3 parent items asked for frequency of symptoms over the past 4 weeks and were presented on a 6-point scale.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Online Asthma Self-Management for Children Aged 5-10 and Their Parents
Official Title  ICMJE Online Asthma Self-Management for Children Aged 5-10 and Their Parents
Brief Summary The potential benefits of this research to public health include improved understanding of cultural factors in pediatric asthma self-management, improved self-management skills for children, and better asthma management skills for their parents. This could result in eased suffering and improved quality of life for millions of children and their families, and also reduce the economic burden borne by society in the forms of medical expenditures and lost productivity.
Detailed Description This proposal will create an interactive multimedia (IMM) program designed to support the self-management efforts of asthmatic children aged 5-10 years and their families. This behavior change program will be designed to promote self-management by (a) increasing child and caregiver knowledge about asthma, (b) encouraging compliance with medication protocols and environmental controls, and (c) increasing self-efficacy to create and implement an Asthma Action Plan.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Asthma
Intervention  ICMJE
  • Behavioral: Lungtropolis
    A game-based website for children with asthma aged 5-10 to teach basic self-management skills and a comprehensive adjunct informational website for parents
  • Behavioral: Asthma educational booklet
    Text-based asthma education booklet for parents and children in PDF format
Study Arms  ICMJE
  • Experimental: Lungtropolis
    A game-based website for children with asthma aged 5-10 to teach basic self-management skills and a comprehensive adjunct informational website for parents
    Intervention: Behavioral: Lungtropolis
  • Active Comparator: Asthma educational booklet
    Text-based asthma education booklet for parents and children in PDF format
    Intervention: Behavioral: Asthma educational booklet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2015)
622
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children aged 5-10 with physican-diagnosed asthma and who had been prescribed any type of asthma medication, and one of their parents or primary caregivers. Parents and children needed to have access to an internet- and video-capable computer, and the parent needed to have a valid e-mail address in order to receive study-related correspondence.

Exclusion Criteria:

  • Only English-speaking participants were accepted because the program was developed only for English speakers. Children less than 5 years of age and older than 10 were excluded because the program is developed targeted to the developmental abilities and interests of children aged 5-10. There were no exclusions based on race/ethnicity.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02602392
Other Study ID Numbers  ICMJE SBIR77R-2RR
R44HL077965-02A2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susan Schroeder, Oregon Center for Applied Science, Inc.
Study Sponsor  ICMJE Oregon Center for Applied Science, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Susan Schroeder, MPH, MCHES Oregon Center for Applied Science
PRS Account Oregon Center for Applied Science, Inc.
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP