AsthmaNCT01072123
Asthma Education Using Child Life Services and an Asthma-based Computer Game
A study testing Quest for the Code in people with Asthma, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a single center pilot study designed to evaluate the effectiveness of an asthma education program in the pediatric emergency department. Asthma has reached epidemic proportions. Nine million American children are affected in the United States alone. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- Quest for the Code
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2010
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between six to eighteen years old
- Diagnosis of asthma
Who cannot join
- Refused to participate in the study
- Unable to understand or respond to questions
- If participants are not English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: Innovative Asthma Education Using a Unique Blend of Child Life Services and an Asthma-based Computer Game in the Pediatric Emergency Room
This is a single center pilot study designed to evaluate the effectiveness of an asthma education program in the pediatric emergency department. Asthma has reached epidemic proportions. Nine million American children are affected in the United States alone. This problem has increased 75% from 1980 to 1994, with a staggering 160% increase seen in children less than five years old.1 The American Lung Association has targeted this overwhelming problem on both national and local levels. Asthma impacts American communities who differ geographically, culturally, ethnically and by lifestyle, and as a result will present with different obstacles.
The primary objectives are: to determine whether this educational intervention (through interactions with a child life specialist and using the asthma based computer game) in the pediatric ED can influence children's [and care givers'] knowledge and understanding of the disease process and treatment, and to improve asthma self-management and decrease morbidity by decreasing ED use and hospitalization.
Read more
A secondary objective is to introduce the Child Life Specialist as an effective asthma educator and further strengthen the health care team.
The target population will be recruited from the pediatric emergency department. We anticipate this study to recruit over a one year period and have a one year follow up with an anticipated enrollment of 64 children and families. There will be three Child Life Specialist involved in this program.
After consent has been obtained, the child and parent will complete questionnaires (focusing on asthma knowledge, quality of life, and perception of asthma) and then a laptop will be provided to access the asthma based computer game.
During the child's ED visit the Child Life Specialist will have opportunities to open communication to address barriers or concerns, and reinforce material provided by the game. Through these interactions, the importance of communication between the child, parent and healthcare provider is highlighted.
The family will be given information to access the computer game via the internet. Follow up phone calls or e-mails will occur at 6 months, 9 months, and 12 months which will entail completing questionnaires. The questionnaires uses validated questions along with questions from the material covered through this asthma education study.
- Conditions
- Asthma
- Being tested
- Quest for the Code
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quest for the CodeOther
interactive asthma-based computer program
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether an educational intervention in the pediatric ED or during hospitalization can influence children's [and care givers'] knowledge and understanding of the disease process and treatment.
Measured: 1 year
To improve communication, asthma self-management and decrease morbidity by decreasing ED use and hospitalization
Measured: 1 year
Secondary outcomes (1)
To introduce the Child Life Specialist as an effective asthma educator and further strengthen the health care team
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Winthrop University Hospital
- Responsible party
- Sponsor
- Investigators
- Mary Cataletto, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072123
- Sponsor's protocol ID
- 08313
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2010
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Gupta RS, Zhang X, Sharp LK, Shannon JJ, Weiss KB. Geographic variability in childhood asthma prevalence in Chicago. J Allergy Clin Immunol. 2008 Mar;121(3):639-645.e1. doi: 10.1016/j.jaci.2007.11.036. Epub 2008 Feb 4.
PubMed 18243285Smeeton NC, Rona RJ, Gregory J, White P, Morgan M. Parental attitudes towards the management of asthma in ethnic minorities. Arch Dis Child. 2007 Dec;92(12):1082-7. doi: 10.1136/adc.2006.112037. Epub 2007 Feb 6.
PubMed 17284478Zayas LE, McLean D. Asthma patient education opportunities in predominantly minority urban communities. Health Educ Res. 2007 Dec;22(6):757-69. doi: 10.1093/her/cyl070. Epub 2006 Aug 8.
PubMed 16896054Wakefield M, Staugas R, Ruffin R, Campbell D, Beilby J, McCaul K. Risk factors for repeat attendance at hospital emergency departments among adults and children with asthma. Aust N Z J Med. 1997 Jun;27(3):277-84. doi: 10.1111/j.1445-5994.1997.tb01979.x.
PubMed 9227811Wasilewski Y, Clark NM, Evans D, Levison MJ, Levin B, Mellins RB. Factors associated with emergency department visits by children with asthma: implications for health education. Am J Public Health. 1996 Oct;86(10):1410-5. doi: 10.2105/ajph.86.10.1410.
PubMed 8876510Franks TJ, Burton DL, Simpson MD. Patient medication knowledge and adherence to asthma pharmacotherapy: a pilot study in rural Australia. Ther Clin Risk Manag. 2005 Mar;1(1):33-8. doi: 10.2147/tcrm.1.1.33.53598.
PubMed 18360541Flores G, Abreu M, Tomany-Korman S, Meurer J. Keeping children with asthma out of hospitals: parents' and physicians' perspectives on how pediatric asthma hospitalizations can be prevented. Pediatrics. 2005 Oct;116(4):957-65. doi: 10.1542/peds.2005-0712.
PubMed 16199708Cagan ER, Hubinsky T, Goodman A, Deitcher D, Cohen NL. Partnering with communities to improve health: the New York City Turning Point experience. J Urban Health. 2001 Mar;78(1):176-80. doi: 10.1093/jurban/78.1.176.
PubMed 11368196Lara M, Rosenbaum S, Rachelefsky G, Nicholas W, Morton SC, Emont S, Branch M, Genovese B, Vaiana ME, Smith V, Wheeler L, Platts-Mills T, Clark N, Lurie N, Weiss KB. Improving childhood asthma outcomes in the United States: a blueprint for policy action. Pediatrics. 2002 May;109(5):919-30. doi: 10.1542/peds.109.5.919.
PubMed 11986457Persky V, Coover L, Hernandez E, Contreras A, Slezak J, Piorkowski J, Curtis L, Turyk M, Ramakrishnan V, Scheff P. Chicago community-based asthma intervention trial: feasibility of delivering peer education in an inner-city population. Chest. 1999 Oct;116(4 Suppl 1):216S-223S. doi: 10.1378/chest.116.suppl_2.216s.
PubMed 10532497Krishna S, Francisco BD, Balas EA, Konig P, Graff GR, Madsen RW; Randomized trial. Internet-enabled interactive multimedia asthma education program: a randomized trial. Pediatrics. 2003 Mar;111(3):503-10. doi: 10.1542/peds.111.3.503.
PubMed 12612228
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Asthma Education Using a Unique Blend of Child Life Services and an Asthma-based Computer Game in the Pediatric Emergency Room
- ClinicalTrials.gov ID
- NCT01072123
- Acronym / sponsor ID
- 08313
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Winthrop University Hospital
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Feb 2010 (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.
This is a single center pilot study designed to evaluate the effectiveness of an asthma education program in the pediatric emergency department. Asthma has reached epidemic proportions. Nine million American children are affected in the United States alone. This problem has increased 75% from 1980 to 1994, with a staggering 160% increase seen in children less than five years old.1 The American Lung Association has targeted this overwhelming problem on both national and local levels. Asthma impacts American communities who differ geographically, culturally, ethnically and by lifestyle, and as a result will present with different obstacles.
The primary objectives are: to determine whether this educational intervention (through interactions with a child life specialist and using the asthma based computer game) in the pediatric ED can influence children's [and care givers'] knowledge and understanding of the disease process and treatment, and to improve asthma self-management and decrease morbidity by decreasing ED use and hospitalization.
A secondary objective is to introduce the Child Life Specialist as an effective asthma educator and further strengthen the health care team.
The target population will be recruited from the pediatric emergency department. We anticipate this study to recruit over a one year period and have a one year follow up with an anticipated enrollment of 64 children and families. There will be three Child Life Specialist involved in this program.
After consent has been obtained, the child and parent will complete questionnaires (focusing on asthma knowledge, quality of life, and perception of asthma) and then a laptop will be provided to access the asthma based computer game.
During the child's ED visit the Child Life Specialist will have opportunities to open communication to address barriers or concerns, and reinforce material provided by the game. Through these interactions, the importance of communication between the child, parent and healthcare provider is highlighted.
The family will be given information to access the computer game via the internet. Follow up phone calls or e-mails will occur at 6 months, 9 months, and 12 months which will entail completing questionnaires. The questionnaires uses validated questions along with questions from the material covered through this asthma education study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (care provider, investigator)
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age between six to eighteen years old
- Diagnosis of asthma
Key exclusion criteria (3 listed)
- Refused to participate in the study
- Unable to understand or respond to questions
- If participants are not English speaking
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 |
|---|---|---|
| Quest for the Codeinteractive asthma-based computer program | Other | – |
Primary outcome
To determine whether an educational intervention in the pediatric ED or during hospitalization can influence children's [and care givers'] knowledge and understanding of the disease process and treatment.
Time frame: 1 year
To improve communication, asthma self-management and decrease morbidity by decreasing ED use and hospitalization
Time frame: 1 year
1 secondary outcome
To introduce the Child Life Specialist as an effective asthma educator and further strengthen the health care team
Time frame: 1 year
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 28 Feb 2020.
- Background: PubMed 18243285Gupta RS, Zhang X, Sharp LK, Shannon JJ, Weiss KB. Geographic variability in childhood asthma prevalence in Chicago. J Allergy Clin Immunol. 2008 Mar;121(3):639-645.e1. doi: 10.1016/j.jaci.2007.11.036. Epub 2008 Feb 4.
- Background: PubMed 17284478Smeeton NC, Rona RJ, Gregory J, White P, Morgan M. Parental attitudes towards the management of asthma in ethnic minorities. Arch Dis Child. 2007 Dec;92(12):1082-7. doi: 10.1136/adc.2006.112037. Epub 2007 Feb 6.
- Background: PubMed 16896054Zayas LE, McLean D. Asthma patient education opportunities in predominantly minority urban communities. Health Educ Res. 2007 Dec;22(6):757-69. doi: 10.1093/her/cyl070. Epub 2006 Aug 8.
- Background: PubMed 9227811Wakefield M, Staugas R, Ruffin R, Campbell D, Beilby J, McCaul K. Risk factors for repeat attendance at hospital emergency departments among adults and children with asthma. Aust N Z J Med. 1997 Jun;27(3):277-84. doi: 10.1111/j.1445-5994.1997.tb01979.x.
- Background: PubMed 8876510Wasilewski Y, Clark NM, Evans D, Levison MJ, Levin B, Mellins RB. Factors associated with emergency department visits by children with asthma: implications for health education. Am J Public Health. 1996 Oct;86(10):1410-5. doi: 10.2105/ajph.86.10.1410.
- Background: PubMed 18360541Franks TJ, Burton DL, Simpson MD. Patient medication knowledge and adherence to asthma pharmacotherapy: a pilot study in rural Australia. Ther Clin Risk Manag. 2005 Mar;1(1):33-8. doi: 10.2147/tcrm.1.1.33.53598.
- Background: PubMed 16199708Flores G, Abreu M, Tomany-Korman S, Meurer J. Keeping children with asthma out of hospitals: parents' and physicians' perspectives on how pediatric asthma hospitalizations can be prevented. Pediatrics. 2005 Oct;116(4):957-65. doi: 10.1542/peds.2005-0712.
- Background: PubMed 11368196Cagan ER, Hubinsky T, Goodman A, Deitcher D, Cohen NL. Partnering with communities to improve health: the New York City Turning Point experience. J Urban Health. 2001 Mar;78(1):176-80. doi: 10.1093/jurban/78.1.176.
- Background: PubMed 11986457Lara M, Rosenbaum S, Rachelefsky G, Nicholas W, Morton SC, Emont S, Branch M, Genovese B, Vaiana ME, Smith V, Wheeler L, Platts-Mills T, Clark N, Lurie N, Weiss KB. Improving childhood asthma outcomes in the United States: a blueprint for policy action. Pediatrics. 2002 May;109(5):919-30. doi: 10.1542/peds.109.5.919.
- Background: PubMed 10532497Persky V, Coover L, Hernandez E, Contreras A, Slezak J, Piorkowski J, Curtis L, Turyk M, Ramakrishnan V, Scheff P. Chicago community-based asthma intervention trial: feasibility of delivering peer education in an inner-city population. Chest. 1999 Oct;116(4 Suppl 1):216S-223S. doi: 10.1378/chest.116.suppl_2.216s.
- Background: PubMed 12612228Krishna S, Francisco BD, Balas EA, Konig P, Graff GR, Madsen RW; Randomized trial. Internet-enabled interactive multimedia asthma education program: a randomized trial. Pediatrics. 2003 Mar;111(3):503-10. doi: 10.1542/peds.111.3.503.
- gameLink provided by the sponsor.
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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.
Mary Cataletto, MD principal investigator
Winthrop University 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 Quest for the Code in people with Asthma, run by NYU Langone Health 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 2 inclusion and 3 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 28 Feb 2020. 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?
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?
To determine whether an educational intervention in the pediatric ED or during hospitalization can influence children's [and care givers'] knowledge and understanding of the disease process and treatment. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01072123, which also lists 11 linked publications.
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 28 Feb 2020.