AsthmaPhase 2ChildAsthmaNCT02602392
Online Asthma Self-Management for Children Aged 5-10 and Their Parents
A Phase 2 study testing Lungtropolis and Asthma educational booklet in people with Asthma, run by Oregon Center for Applied Science, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Lungtropolis and Asthma educational booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 622 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Center for Applied Science
Eugene, Oregon, 97401
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Lungtropolis, Asthma educational booklet
- Keywords
- Self management, Education, Children, Caregivers, Health Care Providers
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LungtropolisBehavioural
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
Asthma educational bookletBehavioural
Text-based asthma education booklet for parents and children in PDF format
| Study group | Role | What they receive |
|---|---|---|
| Lungtropolis | Experimental | 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 Receives: Behavioral: Lungtropolis |
| Asthma educational booklet | Active comparator | Text-based asthma education booklet for parents and children in PDF format Receives: Behavioral: Asthma educational booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in children's knowledge about asthma
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.
Measured: 45 days
Change from baseline in parents' knowledge about asthma
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.
Measured: 45 days
Change from baseline in children's attitudes toward medication
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.
Measured: 45 days
Change from baseline in parents' attitudes about asthma self-management
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.
Measured: 45 days
Change from baseline in children's self-efficacy to improve asthma self-management
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).
Measured: 45 days
Change from baseline in parents' self-efficacy to improve asthma self-management
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.
Measured: 45 days
Secondary outcomes (1)
Change from baseline in Asthma Control Test
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.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 622 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Center for Applied Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Susan Schroeder, Oregon Center for Applied Science, Inc.
- Investigators
- Susan Schroeder, MPH, MCHES, Principal investigator, Oregon Center for Applied Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602392
- Sponsor's protocol ID
- SBIR77R-2RR
- Other IDs
- R44HL077965-02A2
- Acronym
- ChildAsthma
- Status last verified
- Nov 2015
- First submitted
- 31 May 2013
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Asthma Self-Management for Children Aged 5-10 and Their Parents
- ClinicalTrials.gov ID
- NCT02602392
- Acronym / sponsor ID
- ChildAsthma / SBIR77R-2RR
- Conditions
- Asthma
- Keywords
- Self management, Education, Children, Caregivers, Health Care Providers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 622 participants (actual)
- Lead sponsor
- Oregon Center for Applied Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lungtropolis | Experimental | Behavioral: LungtropolisA game-based website for children with asthma aged 5-10 to teach basic self-management skills and a comprehensive adjunct informational website for parents |
| Asthma educational booklet | Active comparator | Behavioral: Asthma educational bookletText-based asthma education booklet for parents and children in PDF format |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LungtropolisA game-based website for children with asthma aged 5-10 to teach basic self-management skills and a comprehensive adjunct informational website for parents | Behavioural | Lungtropolis |
| Asthma educational bookletText-based asthma education booklet for parents and children in PDF format | Behavioural | Asthma educational booklet |
Primary outcome
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.
1 secondary outcome
Change from baseline in Asthma Control Test
Time frame: 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
- Portal page from which to access the child's asthma game and the parent's informational websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Schroeder, MPH, MCHES principal investigator
Oregon Center for Applied Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lungtropolis and Asthma educational booklet in people with Asthma, run by Oregon Center for Applied Science, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in children's knowledge about asthma (time frame: 45 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2015.