NCT02948738

Brief Summary

Children with asthma are admitted for asthma attacks very frequently in the U.S. The families and children are given basic education about asthma but studies are needed to improve this education so that it makes a meaningful difference in health outcomes and asthma care. This study compares two inpatient education models for children hospitalized with asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

October 27, 2016

Last Update Submit

February 4, 2019

Conditions

Asthmatic Attack

Outcome Measures

Primary Outcomes (1)

  • ER visits

    Number of ER visits in the year after education

    1 year

Study Arms (2)

Interactive Education

EXPERIMENTAL

Interactive asthma education

Behavioral: Interactive Asthma Education

Standard Education

ACTIVE COMPARATOR

Standard asthma education

Behavioral: Standard Asthma Education

Interventions

Interactive Asthma EducationBEHAVIORAL

Active participation to develop asthma action plan and teach back cycles for asthma inhaler teaching/training

Interactive Education
Standard Asthma EducationBEHAVIORAL

Basic review of asthma action plan and inhaler use

Standard Education

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of asthma

You may not qualify if:

  • Active Cardiac Disease
  • Speaks language other than English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann and Robert H. Lurie Childrens Hosptial of Chicago

Chicago, Illinois, 60611, United States

Location

Study Officials

  • Waheeda Samady, MD

    Northwestern University and Lurie Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

October 27, 2016

First Posted

October 28, 2016

Study Start

October 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2018

Last Updated

February 6, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)