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临床试验/NCT05500287
NCT05500287已完成不适用

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

Ege University1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2021年3月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
97
试验地点
1
主要终点
Change from baseline in symptom number

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

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).

干预措施: Virtual Care (Other)

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.

结局指标

主要结局

Change from baseline in symptom number

时间窗: 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

次要结局

  • Change from baseline in quality of life(Baseline and sixth month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve Gümüş

Researcher in the Nursing Faculty

Ege University

研究点 (1)

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