Asthma in ChildrenNCT05500287
Virtual Care In Pediatric Asthma
A study testing Virtual Care in people with Asthma in Children, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to determine the impact of virtual care for children with asthma on the disease management and quality of life of children with asthma. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Virtual Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2021to 20 Apr 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- having a smartphone or tablet with internet connection, parents and patient willing to maintain a daily log of symptoms and medication use
Who cannot join
- Children who had mental problems, had not attended at least one of the training and did not send at least one month of their asthma diary were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Virtual Care Given To Child Patients With Asthma On Disease Management And Quality
The purpose of this study was to determine the impact of virtual care for children with asthma on the disease management and quality of life of children with asthma.
Read the detailed description
After children were randomized by protocol number, they completed the child information form, the quality of life scale of the child with asthma, and the asthma control test at the first interview. PEF meter and asthma diary were given at the first interview. Children in the virtual care group received online training in four modules within the first month.The virtual group provided counseling services by phone and video conference for six months. The control group received the standard care provided in the clinic. Asthma diary data were collected from both groups at the end of each month
- Conditions
- Asthma in Children
- Being tested
- Virtual Care
- Keywords
- Virtual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual CareOther
Children in the virtual care group had distance asthma education, case management and virtual care
| Study group | Role | What they receive |
|---|---|---|
| Virtual Care Group | Experimental | Children in virtual care group (VCG) were given distance asthma education for the first month. The education was given in groups of 5-6 children. Also, short videos were taken by the researcher on how to use medications and nebulizers and were shown in Zoom meetings. The education and videos were prepared by scanning the current literature and expert opinion was obtained from 2 experts in nursing education, 2 experts in pediatric nursing and a expert in the pediatric allergy field. Children and families sent asthma diaries to the researcher every 4 weeks. At the end of the first, third and sixth months, data from asthma diaries were collected via Google Forms. The Pediatric Asthma Child Quality of Life Scale score was also collected through Google Forms at the beginning and end of the sixth month. The patients received support from the researcher on case management via telephone or video call 24/7. Case management was multidisciplinary (a nurse and a specialist). Receives: Other: Virtual Care |
| Control Group | No intervention | Children and families who in the control group (CG), sent asthma diaries to the researcher every 4 weeks. At the end of the first, third and sixth months, data from asthma diaries were collected via Google Forms. The Pediatric Asthma Child Quality of Life Scale score was also collected through Google Forms at the beginning and end of the sixth month. In the CG, the education routinely given by the physician during the outpatient clinic visits continued in the same way. In the name of equality of opportunity, training presentations and videos were shared with the CG at the end of the study. Also, the training presentation was converted into a booklet (videos were added to the booklet in the form of QR codes) and delivered to the clinic in printed form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in symptom number
The children were given a asthma diary to track their daily symptom of asthma. Asthma diary includes symptoms of wheezing, cough, activity limitation, sleep disturbance and response fo the use of rescue medication. The diary includes also peakflow meter values for two times per day. A sympyom day means any day for which child recorded any symptom, or reported the use of rescue medication. Children and families kept an asthma diary throughout the study and sent it to the researcher every 4 weeks
Measured: first, third and the sixth month
Secondary outcomes (1)
Change from baseline in quality of life
The Pediatric Asthma Child Quality of Life Scale score was collected through internet
Measured: Baseline and sixth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start14 Mar 2021
- Primary completion20 Feb 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Gümüş, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500287
- Sponsor's protocol ID
- IRB.E.57802
- Status last verified
- Feb 2026
- First submitted
- 11 Aug 2022
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't plan to make IPD available to other researchers.
Publications
Gumus M, Yardimci F, Duman Senol H, Demir E. Virtual care for paediatric asthma: A randomized controlled trial. Int J Nurs Pract. 2024 Dec;30(6):e13290. doi: 10.1111/ijn.13290. Epub 2024 Aug 6.
PubMed 39107823
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Care Given To Child Patients With Asthma On Disease Management And Quality
- ClinicalTrials.gov ID
- NCT05500287
- Acronym / sponsor ID
- IRB.E.57802
- Conditions
- Asthma in Children
- Keywords
- Virtual Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 14 Mar 2021 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 15 Aug 2022 (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.
The purpose of this study was to determine the impact of virtual care for children with asthma on the disease management and quality of life of children with asthma.
Detailed description
After children were randomized by protocol number, they completed the child information form, the quality of life scale of the child with asthma, and the asthma control test at the first interview. PEF meter and asthma diary were given at the first interview. Children in the virtual care group received online training in four modules within the first month.The virtual group provided counseling services by phone and video conference for six months. The control group received the standard care provided in the clinic. Asthma diary data were collected from both groups at the end of each month
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Virtual Care Group | Experimental | Other: Virtual CareChildren in virtual care group (VCG) were given distance asthma education for the first month. The education was given in groups of 5-6 children. Also, short videos were taken by the researcher on how to use medications and nebulizers and were shown in Zoom meetings. The education and videos were prepared by scanning the current literature and expert opinion was obtained from 2 experts in nursing education, 2 experts in pediatric nursing and a expert in the pediatric allergy field. Children and families sent asthma diaries to the researcher every 4 weeks. At the end of the first, third and sixth months, data from asthma diaries were collected via Google Forms. The Pediatric Asthma Child Quality of Life Scale score was also collected through Google Forms at the beginning and end of the sixth month. The patients received support from the researcher on case management via telephone or video call 24/7. Case management was multidisciplinary (a nurse and a specialist). |
| Control Group | No intervention | –Children and families who in the control group (CG), sent asthma diaries to the researcher every 4 weeks. At the end of the first, third and sixth months, data from asthma diaries were collected via Google Forms. The Pediatric Asthma Child Quality of Life Scale score was also collected through Google Forms at the beginning and end of the sixth month. In the CG, the education routinely given by the physician during the outpatient clinic visits continued in the same way. In the name of equality of opportunity, training presentations and videos were shared with the CG at the end of the study. Also, the training presentation was converted into a booklet (videos were added to the booklet in the form of QR codes) and delivered to the clinic in printed form. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- having a smartphone or tablet with internet connection, parents and patient willing to maintain a daily log of symptoms and medication use
Key exclusion criteria (1 listed)
- Children who had mental problems, had not attended at least one of the training and did not send at least one month of their asthma diary were excluded from the study.
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 |
|---|---|---|
| Virtual CareChildren in the virtual care group had distance asthma education, case management and virtual care | Other | Virtual Care Group |
Primary outcome
Change from baseline in symptom number
Time frame: first, third and the sixth month
The children were given a asthma diary to track their daily symptom of asthma. Asthma diary includes symptoms of wheezing, cough, activity limitation, sleep disturbance and response fo the use of rescue medication. The diary includes also peakflow meter values for two times per day. A sympyom day means any day for which child recorded any symptom, or reported the use of rescue medication. Children and families kept an asthma diary throughout the study and sent it to the researcher every 4 weeks
1 secondary outcome
Change from baseline in quality of life
Time frame: Baseline and sixth month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Derived from this study: PubMed 39107823Gumus M, Yardimci F, Duman Senol H, Demir E. Virtual care for paediatric asthma: A randomized controlled trial. Int J Nurs Pract. 2024 Dec;30(6):e13290. doi: 10.1111/ijn.13290. Epub 2024 Aug 6.
- Individual participant dataSharing planned: No. We don't plan to make IPD available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Care in people with Asthma in Children, run by Ege University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 9 Feb 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in symptom number (time frame: first, third and the sixth month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05500287, which also lists 1 linked publication.
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 9 Feb 2026.