Asthma Inpatient Research on Education (AIREd)

February 4, 2019 updated by: Waheeda Samady, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Asthma Inpatient Research on Education: A Randomized Clinical Trial

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.

Study Overview

Detailed Description

The current standard is to review an asthma action plan with families and to review inhaler medication administration. In this study, investigators will be assigning families to either a control (current standard education) or and intervention group. In the intervention group, participants will receive interactive education based on learning theories that are thought to enhance long term memory. Participants in the interactive group will build their own action plan using colored templates and pictures. Participants will also learn to use their inhaler using teach-back methodologies. Investigators will then compare the two groups in terms of ER visits, hospitalizations, family confidence in managing asthma, asthma knowledge, and quality of life.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann and Robert H. Lurie Childrens Hosptial of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of asthma

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interactive Education
Interactive asthma education
Active participation to develop asthma action plan and teach back cycles for asthma inhaler teaching/training
Active Comparator: Standard Education
Standard asthma education
Basic review of asthma action plan and inhaler use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ER visits
Time Frame: 1 year
Number of ER visits in the year after education
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Waheeda Samady, MD, Northwestern University and Lurie Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

October 28, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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