NCT05500287

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

August 11, 2022

Last Update Submit

February 5, 2026

Conditions

Keywords

Virtual Care

Outcome Measures

Primary Outcomes (1)

  • 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

    first, third and the sixth month

Secondary Outcomes (1)

  • Change from baseline in quality of life

    Baseline and sixth month

Study Arms (2)

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).

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.

Interventions

Children in the virtual care group had distance asthma education, case management and virtual care

Virtual Care Group

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • having a smartphone or tablet with internet connection, parents and patient willing to maintain a daily log of symptoms and medication use

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, İzmir, 35040, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher in the Nursing Faculty

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 15, 2022

Study Start

March 14, 2021

Primary Completion

February 20, 2022

Study Completion

April 20, 2022

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

We don't plan to make IPD available to other researchers.

Locations