NCT01447459

Brief Summary

The investigators hypothesize that reinforced asthma education improves long-term outcomes in children with asthma. Specific Aims and Objectives:

  1. 1.To determine the retention rate of parental knowledge about asthma;
  2. 2.To evaluate the clinical status, quality of life and healthcare costs of children with asthma following an educational intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Feb 2011

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

February 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 6, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1.7 years

First QC Date

September 27, 2011

Last Update Submit

November 13, 2017

Conditions

Asthma

Keywords

AsthmaAsthma Education

Outcome Measures

Primary Outcomes (1)

  • Asthma Knowledge Scores (AKS)

    The Asthma Knowledge Quiz will be administered. The higher the score (AKS), the better the knowledge of the caregiver regarding asthma, symptom recognition, trigger identification and avoidance, and medication administration. The PI or the study coordinator will calculate AKSt0, AKSt1, AKSt2, and AKSt3 (enrollment, 1 week, 2 weeks and 3 months, respectively) for each caregiver enrolled in the study. These scores will be recorded in the Asthma Knowledge Quiz Score/Asthma Knowledge Retention Rates Form for each individual subject.

    3 months

Secondary Outcomes (4)

  • Asthma Knowledge Retention Rates (AKRR)

    2 weeks, 1 month, and 3 months after the initial educational intervention

  • Quality of Life/Asthma Control Test Scores (QOL/ACT Scores)

    At enrollment; 2 weeks, 1 month and 3 months after enrollment

  • Functional Status

    Enrollment; 2 weeks, 1 month and 3 months after enrollment

  • Asthma-related healthcare costs

    6 months after enrollment

Study Arms (2)

Reinforced Education

EXPERIMENTAL

The caregivers of the subjects enrolled in this group will be administered two survey instruments at enrollment (t0), and again via telephone at 2 weeks (t1), 1 months (t2), and 3 months (t3) after enrollment. This group will also receive reinforced asthma education via telephone at 2 weeks, 1 month, and 3 months after enrollment.

Behavioral: Reinforced Asthma Education

No Reinforced Education

NO INTERVENTION

The caregivers of the subjects enrolled in this group will be administered two survey instruments at enrollment (t0), and again via telephone at 2 weeks (t1), 1 month (t2), and 3 months (t3) after enrollment. This group will not receive reinforcing of the asthma education at 2 weeks, 1 month, and 3 months after enrollment.

Interventions

Reinforced Asthma EducationBEHAVIORAL

Before beginning the actual study, a board-certified Asthma Educator (AE) will prepare and administer an asthma education training session for the study personnel, including the PI, the co-investigators, and the study coordinator. The AE will also make herself available via pager for assistance with questions from the study personnel regarding asthma education. At the end of the administration of the phone surveys (i.e. at 2 weeks, 1 month and 3 months following enrollment), the study coordinator will provide reinforced asthma education to the caregiver via telephone for the subjects enrolled in Group A (the intervention group). The reinforced asthma education will be consistent with the asthma education training session delivered by the AE before the beginning of the study.

Reinforced Education

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children age 5-12 years (eligible on or after the 5th birthday, until the day before the 13th birthday);
  • Hospitalized at Norton Children's Hospital (KCH) for asthma;
  • Physician diagnosis of asthma (ICD-9 codes 493.00, 493.01, 493.02, 493.10, 493.11, 493.12, 493.90, 493.91, 493.92);
  • Completion of asthma education (standard of care);
  • Ability of parent/legal guardian to give informed consent/research authorization, as evidenced by signing the Informed Consent Form (ICF) approved by the University of Louisville (UofL) IRB;
  • Ability of subject to give informed assent for subjects equal to or older than 7 years of age, as evidenced by signing the Informed Assent Form (IAF) approved by UofL IRB.

You may not qualify if:

  • Previous enrollment in either group of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Related Publications (14)

  • Braman SS, Vigg A. The National Asthma Education and Prevention Program (NAEPP) guidelines: will they improve the quality of care in America? Med Health R I. 2008 Jun;91(6):166-8. No abstract available.

    PMID: 18610803BACKGROUND

  • Bryant-Stephens T, Li Y. Community asthma education program for parents of urban asthmatic children. J Natl Med Assoc. 2004 Jul;96(7):954-60.

    PMID: 15253327BACKGROUND

  • Bravata DM, Gienger AL, Holty JE, Sundaram V, Khazeni N, Wise PH, McDonald KM, Owens DK. Quality improvement strategies for children with asthma: a systematic review. Arch Pediatr Adolesc Med. 2009 Jun;163(6):572-81. doi: 10.1001/archpediatrics.2009.63.

    PMID: 19487615BACKGROUND

  • Coffman JM, Cabana MD, Halpin HA, Yelin EH. Effects of asthma education on children's use of acute care services: a meta-analysis. Pediatrics. 2008 Mar;121(3):575-86. doi: 10.1542/peds.2007-0113.

    PMID: 18310208BACKGROUND

  • Guevara JP, Wolf FM, Grum CM, Clark NM. Effects of educational interventions for self management of asthma in children and adolescents: systematic review and meta-analysis. BMJ. 2003 Jun 14;326(7402):1308-9. doi: 10.1136/bmj.326.7402.1308.

    PMID: 12805167BACKGROUND

  • Gupta RS, Weiss KB. The 2007 National Asthma Education and Prevention Program asthma guidelines: accelerating their implementation and facilitating their impact on children with asthma. Pediatrics. 2009 Mar;123 Suppl 3:S193-8. doi: 10.1542/peds.2008-2233J.

    PMID: 19221163BACKGROUND

  • Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.

    PMID: 14713908BACKGROUND

  • Nicholas DB, Dell SD, Fleming-Carroll B, Selkirk EK. An evaluation of pediatric asthma educational resources. Soc Work Health Care. 2009;48(4):450-61. doi: 10.1080/00981380802589936.

    PMID: 19396712BACKGROUND

  • McPherson AC, Glazebrook C, Forster D, James C, Smyth A. A randomized, controlled trial of an interactive educational computer package for children with asthma. Pediatrics. 2006 Apr;117(4):1046-54. doi: 10.1542/peds.2005-0666.

    PMID: 16585298BACKGROUND

  • Murphy KR, Zeiger RS, Kosinski M, Chipps B, Mellon M, Schatz M, Lampl K, Hanlon JT, Ramachandran S. Test for respiratory and asthma control in kids (TRACK): a caregiver-completed questionnaire for preschool-aged children. J Allergy Clin Immunol. 2009 Apr;123(4):833-9.e9. doi: 10.1016/j.jaci.2009.01.058.

    PMID: 19348922BACKGROUND

  • 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

  • Taggart VS, Zuckerman AE, Sly RM, Steinmueller C, Newman G, O'Brien RW, Schneider S, Bellanti JA. You Can Control Asthma: evaluation of an asthma education program for hospitalized inner-city children. Patient Educ Couns. 1991 Feb;17(1):35-47. doi: 10.1016/0738-3991(91)90049-b.

    PMID: 1997997BACKGROUND

  • Wang LY, Zhong Y, Wheeler L. Direct and indirect costs of asthma in school-age children. Prev Chronic Dis. 2005 Jan;2(1):A11. Epub 2004 Dec 15.

    PMID: 15670464BACKGROUND

  • Asthma prevalence, Health Care Use and Mortality, 2002. National Center for Health Statistics, Health Data for All Ages (HDAA). http://www.cdc.gov/nchs/products/pubs/pubd/hestats/asthma/asthma.htm.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Carmen T Condurache, M.D.

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 27, 2011

First Posted

October 6, 2011

Study Start

February 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

US(1)