NCT01072123

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

1.9 years

First QC Date

February 18, 2010

Last Update Submit

February 26, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • To improve communication, asthma self-management and decrease morbidity by decreasing ED use and hospitalization

    1 year

Secondary Outcomes (1)

  • To introduce the Child Life Specialist as an effective asthma educator and further strengthen the health care team

    1 year

Interventions

interactive asthma-based computer program

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between six to eighteen years old
  • Diagnosis of asthma

You may not qualify if:

  • Refused to participate in the study
  • Unable to understand or respond to questions
  • If participants are not English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Related Publications (11)

  • 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.

    PMID: 18243285BACKGROUND
  • 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. doi: 10.1136/adc.2006.112037. Epub 2007 Feb 6.

    PMID: 17284478BACKGROUND
  • Zayas 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.

    PMID: 16896054BACKGROUND
  • 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. doi: 10.1111/j.1445-5994.1997.tb01979.x.

    PMID: 9227811BACKGROUND
  • 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. doi: 10.2105/ajph.86.10.1410.

    PMID: 8876510BACKGROUND
  • 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. doi: 10.2147/tcrm.1.1.33.53598.

    PMID: 18360541BACKGROUND
  • 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. doi: 10.1542/peds.2005-0712.

    PMID: 16199708BACKGROUND
  • 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. doi: 10.1093/jurban/78.1.176.

    PMID: 11368196BACKGROUND
  • 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. doi: 10.1542/peds.109.5.919.

    PMID: 11986457BACKGROUND
  • 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. doi: 10.1378/chest.116.suppl_2.216s.

    PMID: 10532497BACKGROUND
  • Krishna 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.

    PMID: 12612228BACKGROUND

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Mary Cataletto, MD

    Winthrop University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 19, 2010

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 28, 2020

Record last verified: 2020-02

Locations