Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Lungtropolis Behavioral: Asthma educational booklet Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 622 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Online Asthma Self-Management for Children Aged 5-10 and Their Parents
Study Start Date : January 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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
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

Active Comparator: Asthma educational booklet
Text-based asthma education booklet for parents and children in PDF format
Behavioral: Asthma educational booklet
Text-based asthma education booklet for parents and children in PDF format




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602392


Locations
Layout table for location information
United States, Oregon
Oregon Center for Applied Science
Eugene, Oregon, United States, 97401
Sponsors and Collaborators
Oregon Center for Applied Science, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Susan Schroeder, MPH, MCHES Oregon Center for Applied Science
Additional Information:
Layout table for additonal information
Responsible Party: Susan Schroeder, Research Scientist, Oregon Center for Applied Science, Inc.
ClinicalTrials.gov Identifier: NCT02602392    
Other Study ID Numbers: SBIR77R-2RR
R44HL077965-02A2 ( U.S. NIH Grant/Contract )
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: November 2015
Keywords provided by Susan Schroeder, Oregon Center for Applied Science, Inc.:
Self management
Education
Children
Caregivers
Health Care Providers
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases