NCT05068986

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 25, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

September 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

September 25, 2021

Last Update Submit

October 5, 2021

Conditions

Keywords

asthma, pediatric, education

Outcome Measures

Primary Outcomes (1)

  • The emergency room visits frequency

    to reduce the number of ER visits

    2 months

Study Arms (1)

single arm intervention

OTHER
Behavioral: Asthma education

Interventions

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

single arm intervention

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Children with underlying chronic lung diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children hospital

Cairo, Abbasia, 02, Egypt

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2021

First Posted

October 6, 2021

Study Start

September 26, 2021

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

October 6, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations