The Frequency of ER Visits in Asthmatic ChildrenNCT05068986
Asthma Education and Emergency Department Visits by Asthmatic Children
A study testing Asthma education in people with The Frequency of ER Visits in Asthmatic Children, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- The Frequency of ER Visits in Asthmatic Children
- What is being tested?
- Asthma education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Sep 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with a documented asthma diagnosis Children aged from 1 to 15 years
Who cannot join
- Children with underlying chronic lung diseases
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Children hospital
Cairo, Abbasia, 02
heba Ali, MD, 01200828030, heba_omara@hotmail.com
About this study
Official title: Asthma Education and Its Impact on Emergency Department Visits by Asthmatic Children
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.
Read the 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.
- Being tested
- Asthma education
- Keywords
- asthma, pediatric, education
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma educationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| single arm intervention | Other | Not described Receives: Behavioral: Asthma education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The emergency room visits frequency
to reduce the number of ER visits
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start26 Sep 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Frequency of ER Visits in Asthmatic ChildrenStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068986
- Sponsor's protocol ID
- AinShamsUISA
- Status last verified
- Sep 2021
- First submitted
- 25 Sep 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Education and Its Impact on Emergency Department Visits by Asthmatic Children
- ClinicalTrials.gov ID
- NCT05068986
- Acronym / sponsor ID
- AinShamsUISA
- Keywords
- asthma, pediatric, education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 26 Sep 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm intervention | Other | Behavioral: Asthma education |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with a documented asthma diagnosis Children aged from 1 to 15 years
Key exclusion criteria (1 listed)
- Children with underlying chronic lung diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asthma educationAll 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 | Behavioural | single arm intervention |
Primary outcome
The emergency room visits frequency
Time frame: 2 months
to reduce the number of ER visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma education in people with The Frequency of ER Visits in Asthmatic Children, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The emergency room visits frequency (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.