The Effect of an Avatar-Based Education Program on Shunt Complications and Parents' Knowledge and Care Skills

January 29, 2024 updated by: Mustafa Volkan DÜZGÜN, Akdeniz University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey
        • Akdeniz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Not using the ABEP-H actively

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
No Intervention: Control Group
The control group will receive the standard care procedures of the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VP Shunt Complication Follow-up List (VP-CFL)
Time Frame: 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.
1. month
VP Shunt Complication Follow-up List (VP-CFL)
Time Frame: 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.
3. months
VP Shunt Complication Follow-up List (VP-CFL)
Time Frame: 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.
6. months
Hydrocephalus Knowledge and Care Skills Self-Assessment Scale
Time Frame: 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.
At the beginning of the research
Hydrocephalus Knowledge and Care Skills Self-Assessment Scale
Time Frame: 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.
6. months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child and Parent Descriptive Questionnaire
Time Frame: At the beginning of the research
The Child and Parent Descriptive Questionnaire (CPDQ) was based on a literature review conducted by the researchers. It consists of two parts. The first part consists of 10 items on children's sociodemographic characteristics and hydrocephalus. The second part consists of 13 items on parents' sociodemographic characteristics.
At the beginning of the research
System Usability Scale (SUS)
Time Frame: 6. Months
The System Usability Scale (SUS) was developed by John Brooke and adapted to Turkish by Demirkol and Şeneler to measure the usability of products and services (hardware, software, mobile devices, websites, apps, etc.). The instrument consists of ten items rated on a five-point Likert-type scale (0: strongly disagree, 1: disagree, 2: undecided, 3: agree, 4: strongly agree). Five items (2, 4, 6, 8, and 10) are reverse scored. Each score is multiplied by 2.5 to convert to a scale of 0 to 100, where 100 represents the best possible usability.
6. Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Collaborators

The Scientific and Technological Research Council of Turkey

Investigators

  • Study Director: Ayşegül ISLER DALGIC, Prof, Akdeniz University
  • Study Director: Mehmet Saim KAZAN, Prof, Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

January 28, 2024

Study Registration Dates

First Submitted

April 3, 2022

First Submitted That Met QC Criteria

May 6, 2022

First Posted (Actual)

May 11, 2022

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KAEK-98
  • 221S685 (Other Grant/Funding Number: TUBITAK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It will not be shared for the purpose of confidentiality and protection of personal data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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