NCT01981564

Brief Summary

Asthma is the number one cause of pediatric emergency department (ED) visits in young minority children and is responsible for high healthcare costs. The ED is often the point of contact for many inner city children and many families view the ED as the child's primary source of asthma care. This study plans to test a new model of asthma care, Asthma Express (AEx), that includes a follow-up asthma visit in the ED for an asthma "check-up" , asthma education, a prescription for preventive asthma medications, an appointment for the child to see their pediatric provider and a home visit to assist families with environmental control methods to prevent asthma symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable asthma

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

April 15, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
1 month until next milestone

Results Posted

Study results publicly available

April 13, 2018

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

4.9 years

First QC Date

October 30, 2013

Results QC Date

March 14, 2018

Last Update Submit

March 4, 2019

Conditions

Asthma

Keywords

PediatricEmergency department visit

Outcome Measures

Primary Outcomes (1)

  • Symptom Days

    Symptom days for asthma during past 14 days

    3 months

Secondary Outcomes (1)

  • Emergency Department (ED) Visits for Asthma

    3 months

Study Arms (2)

Asthma Express Intervention

EXPERIMENTAL

Clinic visit for asthma education + nurse home visits

Behavioral: Asthma Express Intervention

Standard Asthma Education Control group

ACTIVE COMPARATOR

Standard asthma education during nurse home visits

Behavioral: Standard Asthma Education Control Group

Interventions

Asthma Express InterventionBEHAVIORAL

Asthma Express clinic visit for asthma education + nurse home visit

Also known as: Asthma Express
Asthma Express Intervention
Standard Asthma Education Control GroupBEHAVIORAL

Asthma Express home nurse visits for asthma education

Also known as: Attention Control
Standard Asthma Education Control group

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • asthma diagnosis,
  • age 3 to 12 years,
  • two or more ED visits or one hospitalization for asthma within past 12 months, -working phone

You may not qualify if:

  • other respiratory chronic disease such as Cystic Fibrosis or Bronchopulmonary dysplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital Pediatric Emergency Department

Baltimore, Maryland, 21287, United States

Location

Related Publications (11)

  • Kub JE, DePriest KN, Bellin MH, Butz A, Lewis-Land C, Morphew T. Predictors of Depressive Symptoms in Caregivers of Children With Poorly Controlled Asthma: Is the Neighborhood Context Important? Fam Community Health. 2022 Jan-Mar 01;45(1):10-22. doi: 10.1097/FCH.0000000000000313.

    PMID: 34783687DERIVED

  • Margolis RHF, Dababnah S, Sacco P, Jones-Harden B, Bollinger ME, Butz A, Bellin MH. The Effects of Caregiver Social Support and Depressive Symptoms on Child Medication Adherence and Asthma Control. J Racial Ethn Health Disparities. 2022 Aug;9(4):1234-1242. doi: 10.1007/s40615-021-01065-w. Epub 2021 May 26.

    PMID: 34041705DERIVED

  • Margolis RHF, Bellin MH, Bookman JRM, Collins KS, Bollinger ME, Lewis-Land C, Butz AM. Fostering Effective Asthma Self-Management Transfer in High-Risk Children: Gaps and Opportunities for Family Engagement. J Pediatr Health Care. 2019 Nov-Dec;33(6):684-693. doi: 10.1016/j.pedhc.2019.05.004. Epub 2019 Jun 26.

    PMID: 31253454DERIVED

  • Bollinger ME, Butz A, Tsoukleris M, Lewis-Land C, Mudd S, Morphew T. Characteristics of inner-city children with life-threatening asthma. Ann Allergy Asthma Immunol. 2019 Apr;122(4):381-386. doi: 10.1016/j.anai.2019.02.002. Epub 2019 Feb 10.

    PMID: 30742915DERIVED

  • Butz AM, Tsoukleris M, Elizabeth Bollinger M, Jassal M, Bellin MH, Kub J, Mudd S, Ogborn CJ, Lewis-Land C, Thompson RE. Association between second hand smoke (SHS) exposure and caregiver stress in children with poorly controlled asthma. J Asthma. 2019 Sep;56(9):915-926. doi: 10.1080/02770903.2018.1509989. Epub 2018 Oct 11.

    PMID: 30307351DERIVED

  • Bellin MH, Newsome A, Lewis-Land C, Kub J, Mudd SS, Margolis R, Butz AM. Improving Care of Inner-City Children with Poorly Controlled Asthma: What Mothers Want You to Know. J Pediatr Health Care. 2018 Jul-Aug;32(4):387-398. doi: 10.1016/j.pedhc.2017.12.009. Epub 2018 Mar 12.

    PMID: 29540280DERIVED

  • Butz AM, Bellin M, Tsoukleris M, Mudd SS, Kub J, Ogborn J, Morphew T, Lewis-Land C, Bollinger ME. Very Poorly Controlled Asthma in Urban Minority Children: Lessons Learned. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):844-852. doi: 10.1016/j.jaip.2017.08.007. Epub 2017 Sep 22.

    PMID: 28958744DERIVED

  • Butz A, Morphew T, Lewis-Land C, Kub J, Bellin M, Ogborn J, Mudd SS, Bollinger ME, Tsoukleris M. Factors associated with poor controller medication use in children with high asthma emergency department use. Ann Allergy Asthma Immunol. 2017 Apr;118(4):419-426. doi: 10.1016/j.anai.2017.01.007. Epub 2017 Feb 21.

    PMID: 28254203DERIVED

  • Bellin MH, Newsome A, Land C, Kub J, Mudd SS, Bollinger ME, Butz AM. Asthma Home Management in the Inner-City: What can the Children Teach us? J Pediatr Health Care. 2017 May-Jun;31(3):362-371. doi: 10.1016/j.pedhc.2016.11.002. Epub 2016 Dec 9.

    PMID: 27955875DERIVED

  • Bellin MH, Land C, Newsome A, Kub J, Mudd SS, Bollinger ME, Butz AM. Caregiver perception of asthma management of children in the context of poverty. J Asthma. 2017 Mar;54(2):162-172. doi: 10.1080/02770903.2016.1198375. Epub 2016 Jun 15.

    PMID: 27304455DERIVED

  • Butz AM, Ogborn J, Mudd S, Ballreich J, Tsoukleris M, Kub J, Bellin M, Bollinger ME. Factors associated with high short-acting beta2-agonist use in urban children with asthma. Ann Allergy Asthma Immunol. 2015 May;114(5):385-92. doi: 10.1016/j.anai.2015.03.002. Epub 2015 Mar 31.

    PMID: 25840499DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Arlene Butz
Organization
Johns Hopkins University School of Medicine, Department of Pediatrics
abutz@jhmi.edu
410-614-5963

Study Officials

  • Arlene M Butz, ScD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 11, 2013

Study Start

April 15, 2013

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

March 6, 2019

Results First Posted

April 13, 2018

Record last verified: 2019-03

Locations

US(1)