Expired Study
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Eugene, Oregon 97401


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

SBIR77R-2RR


NCT ID:

NCT02602392


Secondary ID:

R44 HL077965-02A2


Study Acronym:

ChildAsthma


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

5 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Oregon Center for Applied Science, Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

622


Enrollment Type:

Actual


Overall Contact Information

Official Name:Susan Schroeder, MPH, MCHES
Principal Investigator
Oregon Center for Applied Science

Study Dates

Start Date:January 2011
Completion Date:September 2011
Completion Type:Actual
Primary Completion Date:September 2011
Primary Completion Type:Actual
Verification Date:November 2015
Last Changed Date:November 9, 2015
First Received Date:May 31, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change from baseline in Asthma Control Test
Time Frame:45 days
Safety Issues:False
Description: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 creat
Outcome Type:Primary Outcome
Measure:Change from baseline in parents' self-efficacy to improve asthma self-management
Time Frame:45 days
Safety Issues:False
Description: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 respo
Outcome Type:Primary Outcome
Measure:Change from baseline in children's self-efficacy to improve asthma self-management
Time Frame:45 days
Safety Issues:False
Description: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-ty
Outcome Type:Primary Outcome
Measure:Change from baseline in parents' attitudes about asthma self-management
Time Frame:45 days
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Change from baseline in children's attitudes toward medication
Time Frame:45 days
Safety Issues:False
Description: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 numb
Outcome Type:Primary Outcome
Measure:Change from baseline in parents' knowledge about asthma
Time Frame:45 days
Safety Issues:False
Description: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 trigge
Outcome Type:Primary Outcome
Measure:Change from baseline in children's knowledge about asthma
Time Frame:45 days
Safety Issues:False
Description: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 numb

Study Interventions

Intervention Type:Behavioral
Name:Lungtropolis
Description: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
Arm Name:Lungtropolis
Intervention Type:Behavioral
Name:Asthma educational booklet
Description:Text-based asthma education booklet for parents and children in PDF format
Arm Name:Asthma educational booklet

Study Arms

Study Arm Type:Active Comparator
Arm Name:Asthma educational booklet
Description:Text-based asthma education booklet for parents and children in PDF format
Study Arm Type:Experimental
Arm Name:Lungtropolis
Description: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

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Oregon Center for Applied Science, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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