- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02948738
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
Status
Completed
Conditions
Intervention / Treatment
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChildrensMemorialH
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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