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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05500287
Other study ID # IRB.E.57802
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 14, 2021
Est. completion date April 20, 2022

Study information

Verified date August 2022
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date April 20, 2022
Est. primary completion date February 20, 2022
Accepts healthy volunteers No
Gender All
Age group 7 Years to 17 Years
Eligibility Inclusion Criteria: - having a smartphone or tablet with internet connection, parents and patient willing to maintain a daily log of symptoms and medication use Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Virtual Care
Children in the virtual care group had distance asthma education, case management and virtual care

Locations

Country Name City State
Turkey Ege University Izmir

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from baseline in quality of life The Pediatric Asthma Child Quality of Life Scale score was collected through internet Baseline and sixth month
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