Virtual Care In Pediatric Asthma

Sponsor

Ege University (Other)

Overall Status

Completed

CT.gov ID

NCT05500287

Collaborator

(none)

Enrollment

Location

Arms

13.2

Actual Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma in Children	Other: Virtual Care	N/A

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

Study Type:

Interventional

Actual Enrollment :

97 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Controlled TrialRandomized Controlled Trial

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Effect of Virtual Care Given To Child Patients With Asthma On Disease Management And Quality

Actual Study Start Date :

Mar 14, 2021

Actual Primary Completion Date :

Feb 20, 2022

Actual Study Completion Date :

Apr 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual Care Group 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 Children in the virtual care group had distance asthma education, case management and virtual care
No Intervention: Control Group 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.

Arm

Intervention/Treatment

Experimental: Virtual Care Group

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

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

No Intervention: Control Group

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.

Outcome Measures

Primary Outcome Measures

Change from baseline in symptom number [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

Secondary Outcome Measures

Change from baseline in quality of life [Baseline and sixth month]
The Pediatric Asthma Child Quality of Life Scale score was collected through internet

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ege University	İzmir		Turkey	35040

Sponsors and Collaborators

Ege University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Merve Gümüş, Dr., Ege University

ClinicalTrials.gov Identifier:

NCT05500287

Other Study ID Numbers:

IRB.E.57802

First Posted:

Aug 15, 2022

Last Update Posted:

Aug 15, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Merve Gümüş, Dr., Ege University

Virtual Care

Additional relevant MeSH terms:

Asthma

Study Results

No Results Posted as of Aug 15, 2022