AsthmaALPNCT00874900
Asthma Learning Project
A study testing Educational game, Educational game + motivational interview and Motivational interview in people with Asthma, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect on knowledge and behavior of playing an educational asthma computer game during a pediatric Emergency Department (ED) asthma visit among children ages 7 - 15 years. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Asthma
- What is being tested?
- Educational game, Educational game + motivational interview and Motivational interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to May 2013
- Phase
- Interventional
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 7 - 15 years, inclusive.
- Patient has a history of asthma or asthma-like symptoms on at least 1 occasion, occurring at least 3 months prior to the current episode (may be verbal per patient/caregiver).
- Patient is presenting to the ED for an acute asthma exacerbation of any type or severity.
- Available for phone call or mail questionnaire in 2 weeks and 3 months.
- Parent able to read English or Spanish.
- Child able to understand spoken English or Spanish.
Show all 9Show fewer
- Child able to use a computer and mouse or stylus.
- Provider believes the patient is likely to remain in ED for at least one hour.
- Informed consent by parent and assent from child
Who cannot join
- Child has previously participated in this study.
- Child has a hearing impairment uncompensated for by assistive listening devices.
- Significant mental disorder or cognitive impairment that the parent believes would preclude competent informed assent or game play.
- Child has a baseline motor disorder and the parent is unable to assist using a mouse and keyboard
- Child has significant medial conditions that have a pulmonary component, in addition to their asthma
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Asthma Learning Project: Randomized Trial of a Computerized Asthma Game in a Pediatric Emergency Department
The purpose of this study is to determine the effect on knowledge and behavior of playing an educational asthma computer game during a pediatric Emergency Department (ED) asthma visit among children ages 7 - 15 years. The ED cares for a high-risk population of children who have difficulty accessing preventive care well. The addition of a computer game to usual asthma emergency care could be a simple, effective, enjoyable way to improve patients' asthma knowledge, beliefs, and management practices. This project has the potential to lead to larger studies evaluating the benefit of education with and without behavioral interventions such as motivational interviewing.
This project plans to implement and evaluate the use of a goal setting activity and the educational asthma computer game, "Quest for the Code" (Starlight Starbright Children's FoundationTM), in the ED of Seattle Children's Hospital. In a randomized trial of Spanish and English speaking children ages 7 - 15 years receiving ED care for their asthma, the investigators will evaluate the effects of the game on children's asthma knowledge, attitudes, and behaviors.
Read more
The investigators aim to compare the change in asthma knowledge and locus of control after 3 months, for children who play the computerized asthma game, versus those who receive standard care in the ED. The investigators will also compare changes in asthma severity and activity limitations over 3 months, for children who play the asthma game without goal-setting, children who playing the game with goal-setting, and children who receive standard care.
Overall, the investigators hypothesize that educational asthma game play by pediatric patients with acute asthma will improve asthma knowledge, compared with standard care.
- Conditions
- Asthma
- Being tested
- Educational game, Educational game + motivational interview, Motivational interview
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational gameOther
"Quest for the Code" is an educational asthma computer game. Participants randomized to this intervention will have access to the game for a minimum of one hour while receiving treatment in the Seattle Children's Emergency Department.
Educational game + motivational interviewOther
"Quest for the Code" is an educational asthma computer game. Participants randomized to this intervention will have access to this game for a minimum of one hour while receiving treatment in the Seattle Children's Emergency Department (ED).Before leaving the ED, participants in this group will have a brief asthma goal setting activity using motivational interview techniques.
Motivational interviewOther
Participant randomized to this group will receive standard care for the treatment of their asthma, including an education asthma booklet developed by Seattle Children's. Before leaving the ED, participants in this group will have a brief asthma goal setting activity using motivational interview techniques.
| Study group | Role | What they receive |
|---|---|---|
| Game | Experimental | Not described Receives: Other: Educational game |
| Game + Activation | Experimental | Not described Receives: Other: Educational game + motivational interview |
| Booklet | No intervention | Not described |
| Booklet + Activation | Experimental | Not described Receives: Other: Motivational interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Knowledge
Measured: 3 months
Secondary outcomes (1)
Locus of control
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startDec 2008
- Primary completionJan 2013 (estimated)
- Study completionMay 2013 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Julie Brown, MD, MPH, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874900
- Sponsor's protocol ID
- ALP12526
- Acronym
- ALP
- Status last verified
- Jul 2011
- First submitted
- 1 Apr 2009
- Last updated
- 8 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Learning Project: Randomized Trial of a Computerized Asthma Game in a Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT00874900
- Acronym / sponsor ID
- ALP / ALP12526
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jan 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 3 Apr 2009 (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 purpose of this study is to determine the effect on knowledge and behavior of playing an educational asthma computer game during a pediatric Emergency Department (ED) asthma visit among children ages 7 - 15 years. The ED cares for a high-risk population of children who have difficulty accessing preventive care well. The addition of a computer game to usual asthma emergency care could be a simple, effective, enjoyable way to improve patients' asthma knowledge, beliefs, and management practices. This project has the potential to lead to larger studies evaluating the benefit of education with and without behavioral interventions such as motivational interviewing.
This project plans to implement and evaluate the use of a goal setting activity and the educational asthma computer game, "Quest for the Code" (Starlight Starbright Children's FoundationTM), in the ED of Seattle Children's Hospital. In a randomized trial of Spanish and English speaking children ages 7 - 15 years receiving ED care for their asthma, the investigators will evaluate the effects of the game on children's asthma knowledge, attitudes, and behaviors.
The investigators aim to compare the change in asthma knowledge and locus of control after 3 months, for children who play the computerized asthma game, versus those who receive standard care in the ED. The investigators will also compare changes in asthma severity and activity limitations over 3 months, for children who play the asthma game without goal-setting, children who playing the game with goal-setting, and children who receive standard care.
Overall, the investigators hypothesize that educational asthma game play by pediatric patients with acute asthma will improve asthma knowledge, compared with standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Game | Experimental | Other: Educational game |
| Game + Activation | Experimental | Other: Educational game + motivational interview |
| Booklet | No intervention | – |
| Booklet + Activation | Experimental | Other: Motivational interview |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Age 7 - 15 years, inclusive.
- Patient has a history of asthma or asthma-like symptoms on at least 1 occasion, occurring at least 3 months prior to the current episode (may be verbal per patient/caregiver).
- Patient is presenting to the ED for an acute asthma exacerbation of any type or severity.
- Available for phone call or mail questionnaire in 2 weeks and 3 months.
- Parent able to read English or Spanish.
Key exclusion criteria (5 listed)
- Child has previously participated in this study.
- Child has a hearing impairment uncompensated for by assistive listening devices.
- Significant mental disorder or cognitive impairment that the parent believes would preclude competent informed assent or game play.
- Child has a baseline motor disorder and the parent is unable to assist using a mouse and keyboard
- Child has significant medial conditions that have a pulmonary component, in addition to their asthma
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 |
|---|---|---|
| Educational game"Quest for the Code" is an educational asthma computer game. Participants randomized to this intervention will have access to the game for a minimum of one hour while receiving treatment in the Seattle Children's Emergency Department. | Other | Game |
| Educational game + motivational interview"Quest for the Code" is an educational asthma computer game. Participants randomized to this intervention will have access to this game for a minimum of one hour while receiving treatment in the Seattle Children's Emergency Department (ED).Before leaving the ED, participants in this group will have a brief asthma goal setting activity using motivational interview techniques. | Other | Game + Activation |
| Motivational interviewParticipant randomized to this group will receive standard care for the treatment of their asthma, including an education asthma booklet developed by Seattle Children's. Before leaving the ED, participants in this group will have a brief asthma goal setting activity using motivational interview techniques. | Other | Booklet + Activation |
Primary outcome
Child Knowledge
Time frame: 3 months
1 secondary outcome
Locus of control
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2011.
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Asthma
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.
Julie Brown, MD, MPH principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational game, Educational game + motivational interview and Motivational interview in people with Asthma, run by Seattle Children's Hospital 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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Jul 2011. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Brown, MD, MPH (206-987-4016, julie.brown@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Knowledge (time frame: 3 months). 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 8 Jul 2011.