- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02602392
Online Asthma Self-Management for Children Aged 5-10 and Their Parents (ChildAsthma)
November 9, 2015 updated by: Susan Schroeder, Oregon Center for Applied Science, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
622
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Eugene, Oregon, United States, 97401
- Oregon Center for Applied Science
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 75 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
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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
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ACTIVE_COMPARATOR: Asthma educational booklet
Text-based asthma education booklet for parents and children in PDF format
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Text-based asthma education booklet for parents and children in PDF format
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
45 days
|
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.
|
45 days
|
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.
|
45 days
|
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.
|
45 days
|
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).
|
45 days
|
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.
|
45 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
45 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (ACTUAL)
September 1, 2011
Study Completion (ACTUAL)
September 1, 2011
Study Registration Dates
First Submitted
May 31, 2013
First Submitted That Met QC Criteria
November 9, 2015
First Posted (ESTIMATE)
November 11, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
November 11, 2015
Last Update Submitted That Met QC Criteria
November 9, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBIR77R-2RR
- R44HL077965-02A2 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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