Asthma Clinical Trial
Official title:
Innovative Asthma Education Using a Unique Blend of Child Life Services and an Asthma-based Computer Game in the Pediatric Emergency Room
| NCT number | NCT01072123 |
| Other study ID # | 08313 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2009 |
| Est. completion date | December 2010 |
| Verified date | February 2020 |
| Source | NYU Langone Health |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 27 |
| Est. completion date | December 2010 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 18 Years |
| Eligibility |
Inclusion Criteria: - Age between six to eighteen years old - Diagnosis of asthma Exclusion Criteria: - Refused to participate in the study - Unable to understand or respond to questions - If participants are not English speaking |
| Country | Name | City | State |
|---|---|---|---|
| United States | Winthrop University Hospital | Mineola | New York |
| Lead Sponsor | Collaborator |
|---|---|
| NYU Langone Health | Winthrop University Hospital |
United States,
Cagan 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. — View Citation
Flores 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. — View Citation
Franks 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. — View Citation
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. Review. — View Citation
Krishna S, Francisco BD, Balas EA, König P, Graff GR, Madsen RW; Randomized trial. Internet-enabled interactive multimedia asthma education program: a randomized trial. Pediatrics. 2003 Mar;111(3):503-10. — View Citation
Lara 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. Review. — View Citation
Persky 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. — View Citation
Smeeton 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. Epub 2007 Feb 6. — View Citation
Wakefield 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. — View Citation
Wasilewski 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. — View Citation
Zayas LE, McLean D. Asthma patient education opportunities in predominantly minority urban communities. Health Educ Res. 2007 Dec;22(6):757-69. Epub 2006 Aug 8. — View Citation
* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 1 year | ||
| Primary | To improve communication, asthma self-management and decrease morbidity by decreasing ED use and hospitalization | 1 year | ||
| Secondary | To introduce the Child Life Specialist as an effective asthma educator and further strengthen the health care team | 1 year |
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