- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05068986
Asthma Education and Emergency Department Visits by Asthmatic Children
Asthma Education and Its Impact on Emergency Department Visits by Asthmatic Children
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Abbasia
-
Cairo, Abbasia, Egypt, 02
- Recruiting
- Children Hospital
-
Contact:
- heba Ali, MD
- Phone Number: 01200828030
- Email: heba_omara@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children with a documented asthma diagnosis Children aged from 1 to 15 years
Exclusion Criteria:
- Children with underlying chronic lung diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: single arm intervention
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The emergency room visits frequency
Time Frame: 2 months
|
to reduce the number of ER visits
|
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AinShamsUISA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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