The Effect of An Avatar-Based Education Program Developed For The Care Of Children With Ventriculoperitoneal Shunts On Shunt Complications And Parents' Knowledge And Care Skills: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- VP Shunt Complication Follow-up List (VP-CFL)
研究概览
简要总结
Hydrocephalus is a common childhood neurosurgical disease. Ventriculoperitoneal (VP) shunt is usually used in the treatment of hydrocephalus. However, VP shunt may have some complications. In developed countries, the incidence of hydrocephalus is 1 per 1000 live births. In developing countries, it is 3-4 per 1000 live births. A multidisciplinary approach is important in the treatment and care of hydrocephalus. Parents need guidance and training for hydrocephalus treatment and care. Nurses should help parents solve all care-related problems. Technology-based nursing interventions have become popular in recent years because they make life easier for children with chronic diseases and their parents who should avoid non-emergency hospital visits during the COVID-19 pandemic. Investigators need innovative and interactive technology-based interventions to provide patients and their parents with the knowledge and skills necessary to manage chronic diseases. This study also focused on an avatar-based education program because avatars are interactive icons that provide intrinsic and extrinsic motivation for parents. Therefore Investigators develop an Avatar-based education program in Hydrocephalus (ABEP-H) and prove its effectiveness in reducing shunt complications and helping parents acquire the knowledge and develop the skills necessary for the care of their children with hydrocephalus.
详细描述
Ventriculoperitoneal (VP) shunt is usually used in the treatment of hydrocephalus. However, VP shunt may have some complications. Children with shunts need good primary care.
There have been significant advances in science and technology in recent years. Therefore, education programs for patients and their parents also involve technology. The new face of technology in patient education is avatar-based education programs used to manage chronic diseases (cancer, diabetes, depression, etc.). However, this technology is underutilized in the training of pediatric patients. Therefore, this study will present a randomized controlled trial protocol to develop an avatar-based education program and determine its effect on shunt complications and parents' knowledge and care skills (ABEP-H).
The ABEP-H protocol adopted a single-blind, pretest-posttest, parallel-group (1:1 ratio), follow-up, multicenter randomized controlled experimental design. The intervention group will attend the ABEP-H for six months. Each intervention group participant will be phoned once every two weeks as a reminder. Data will be collected in the first, third, and sixth months.
The ABEP-H protocol will be based on the template for intervention description and replication (TIDieR) guideline and checklist. The protocol is designed according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). Randomized controlled trials (RCTs) are reported based on the Consolidated Standards of Reporting Trials (CONSORT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having a child with a VP shunt in the past six months
- •No shunt infection
- •Having a smartphone and mobile Internet access
- •Speaking Turkish
- •Understanding what is read and said
- •Executing commands
排除标准
- •Not using the ABEP-H actively
研究组 & 干预措施
Avatar-Based Education Program in Hydrocephalus (ABEP-H)
The avatar-based education program in hydrocephalus (ABEP-H) aimed to help parents acquire the knowledge and develop the skills necessary for the care of hydrocephalus children with VP shunts and prevent shunt infection and dysfunction. The intervention group participants will be sent usernames and passwords they can change by accessing their profiles. The main researcher will show them how to log into the program and use it on their phones and computers. This interview will take about 40 minutes. Afterward, they are expected to use the program for six months on a regular basis. Their login frequency and duration will be monitored. After six months, they will be asked to fill out the System Usability Scale (SUS). Moreover, each participant will be phoned once every two weeks as a reminder.
干预措施: Avatar-Based Education Program in Hydrocephalus (ABEP-H) (Other)
Control Group
The control group will receive the standard care procedures of the hospital.
结局指标
主要结局
VP Shunt Complication Follow-up List (VP-CFL)
时间窗: 6. months
The VP Shunt Complication Follow-up List (VP-CFL) was based on a literature review conducted by the researchers. It consists of 24 parameters about shunt infection and dysfunction. These data will be provided from the patient file. The researcher will collect data on the other parameters during routine consultations and physical examinations. The follow-up of shunt complications in children will be done through this list.
Hydrocephalus Knowledge and Care Skills Self-Assessment Scale
时间窗: 6. months
The researchers are developing the Hydrocephalus Knowledge and Care Skills Self-Assessment Scale (HKCSSAS). It is aimed to measure the knowledge and care skills of parents.The results of the pilot study showed that the scale was valid and reliable.
VP Shunt Complication Follow-up List (VP-CFL)
时间窗: 1. month
The VP Shunt Complication Follow-up List (VP-CFL) was based on a literature review conducted by the researchers. It consists of 24 parameters about shunt infection and dysfunction. These data will be provided from the patient file. The researcher will collect data on the other parameters during routine consultations and physical examinations. The follow-up of shunt complications in children will be done through this list.
VP Shunt Complication Follow-up List (VP-CFL)
时间窗: 3. months
The VP Shunt Complication Follow-up List (VP-CFL) was based on a literature review conducted by the researchers. It consists of 24 parameters about shunt infection and dysfunction. These data will be provided from the patient file. The researcher will collect data on the other parameters during routine consultations and physical examinations. The follow-up of shunt complications in children will be done through this list.
Hydrocephalus Knowledge and Care Skills Self-Assessment Scale
时间窗: At the beginning of the research
The researchers are developing the Hydrocephalus Knowledge and Care Skills Self-Assessment Scale (HKCSSAS). It is aimed to measure the knowledge and care skills of parents.The results of the pilot study showed that the scale was valid and reliable.
次要结局
- Child and Parent Descriptive Questionnaire(At the beginning of the research)
- System Usability Scale (SUS)(6. Months)
研究者
Mustafa Volkan DÜZGÜN
Principal Investigator
Akdeniz University