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Asthma Education and Emergency Department Visits by Asthmatic Children

Primary Purpose

The Frequency of ER Visits in Asthmatic Children

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Asthma education
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for The Frequency of ER Visits in Asthmatic Children focused on measuring asthma, pediatric, education

Eligibility Criteria

1 Year - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children with a documented asthma diagnosis Children aged from 1 to 15 years

Exclusion Criteria:

  • Children with underlying chronic lung diseases

Sites / Locations

  • Children hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

single arm intervention

Arm Description

Outcomes

Primary Outcome Measures

The emergency room visits frequency
to reduce the number of ER visits

Secondary Outcome Measures

Full Information

First Posted
September 25, 2021
Last Updated
October 5, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05068986
Brief Title
Asthma Education and Emergency Department Visits by Asthmatic Children
Official Title
Asthma Education and Its Impact on Emergency Department Visits by Asthmatic Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 26, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will be conducted to evaluate the effects of an educational asthma program on the frequency of emergency department visits and identifying factors associated with frequent emergency department visits by asthmatic children and determine its effect on asthma severity and quality of life among asthmatic children and their caregivers.
Detailed Description
This one-arm interventional clinical trial study will be conducted at pediatric chest clinics and the emergency department of the children's hospital of Ain Shams University located in Cairo during the period from September 2021 to the end of December 2021. The study will be conducted on 30 asthmatic pediatric patients aged from 1-15 years old with documented asthma diagnoses (intermittent wheezes, breathlessness, dry cough, etc) Inclusion criteria: : Objective asthma diagnostic testing consists of 2 components: (1) demonstration of airway obstruction and (2) documentation of variability in the degree of obstruction. Exclusion criteria: Underlying chronic lung diseases like: (Cystic fibrosis, tuberculosis, childhood interstitial lung diseases). Asthmatic patients with major systemic illness (diabetes, chronic renal failure, chronic liver disease). All the study participants will be subjected to an educational asthma program for 3 months to provide parents and children with information and skills to manage their asthma, through avoiding triggers, training in the correct use of medicines, including inhaler technique, information, and support to maximize adherence. All patients will be followed up by a phone call every 2 weeks and a follow-up visit monthly to confirm compliance with the educational program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Frequency of ER Visits in Asthmatic Children
Keywords
asthma, pediatric, education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single arm intervention
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Asthma education
Intervention Description
All the study participants were subjected to an educational asthma program for 3 months for providing parents and children with information and skills to manage their asthma ,which was presented from the the first session, through providing a written asthma action plan, information about avoiding triggers, training in the correct use of medicines, including inhaler technique, information and support to maximize adherence . All patients were followed up by a phone call every 2 weeks and follow up visit monthly to confirm compliance to the educational program
Primary Outcome Measure Information:
Title
The emergency room visits frequency
Description
to reduce the number of ER visits
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with a documented asthma diagnosis Children aged from 1 to 15 years Exclusion Criteria: Children with underlying chronic lung diseases
Facility Information:
Facility Name
Children hospital
City
Cairo
State/Province
Abbasia
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
heba Ali, MD
Phone
01200828030
Email
heba_omara@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Asthma Education and Emergency Department Visits by Asthmatic Children

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