Developing the ABEP-HNCT05370131

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

A study testing Avatar-Based Education Program in Hydrocephalus (ABEP-H) in people with Developing the ABEP-H and Determining the Effect of ABEP-H, run by Akdeniz University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages Up to 18 yearsHealthy volunteers can take part
Conditions the study is for: Developing the ABEP-H, Determining the Effect of ABEP-H
What is being tested?: Avatar-Based Education Program in Hydrocephalus (ABEP-H)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jan 2023to 28 Jan 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

Not using the ABEP-H actively

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Akdeniz University
Antalya

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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).

Conditions: Developing the ABEP-H, Determining the Effect of ABEP-H
Being tested: Avatar-Based Education Program in Hydrocephalus (ABEP-H)
Keywords: hydrocephalus, avatar-based education program, pediatric nursing, shunt complication, parents' knowledge and care skill
Medical subject headings: Hydrocephalus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Avatar-Based Education Program in Hydrocephalus (ABEP-H)Other
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.

Study groups in NCT05370131
Study group	Role	What they receive
Avatar-Based Education Program in Hydrocephalus (ABEP-H)	Experimental	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. Receives: Other: Avatar-Based Education Program in Hydrocephalus (ABEP-H)
Control Group	No intervention	The control group will receive the standard care procedures of the hospital.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Child and Parent Descriptive Questionnaire
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.
Measured: At the beginning of the research
System Usability Scale (SUS)
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.
Measured: 6. Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202328 Jan 2024

First posted11 May 2022
Study start1 Jan 2023
Primary completion1 Dec 2023
Study completion28 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Developing the ABEP-HStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05370131
Sponsor's protocol ID: KAEK-98
Other IDs: 221S685
Status last verified: Jan 2024
First submitted: 3 Apr 2022
Last updated: 30 Jan 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: It will not be shared for the purpose of confidentiality and protection of personal data.

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05370131
Acronym / sponsor ID: KAEK-98
Conditions: Developing the ABEP-H, Determining the Effect of ABEP-H
Keywords: hydrocephalus, avatar-based education program, pediatric nursing, shunt complication, parents' knowledge and care skill
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Akdeniz UniversityUniversity, hospital or other
Collaborators: The Scientific and Technological Research Council of Turkey
Study start: 1 Jan 2023 (actual)
Primary completion: 1 Dec 2023 (actual)
Study completion: 28 Jan 2024 (actual)
First posted: 11 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Avatar-Based Education Program in Hydrocephalus (ABEP-H)	Experimental	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. 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.
Control Group	No intervention	–The control group will receive the standard care procedures of the hospital.

Who may qualify

Ages: Up to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (1 listed)

Not using the ABEP-H actively

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Other	Avatar-Based Education Program in Hydrocephalus (ABEP-H)

Primary outcome

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.
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.
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.
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.
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.

2 secondary outcomes

Child and Parent Descriptive Questionnaire
Time frame: At the beginning of the research
System Usability Scale (SUS)
Time frame: 6. Months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
Individual participant dataSharing planned: No. It will not be shared for the purpose of confidentiality and protection of personal data.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ayşegül ISLER DALGIC, Prof study director

Akdeniz University

Mehmet Saim KAZAN, Prof study director

Akdeniz University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VP Shunt Complication Follow-up List (VP-CFL) (time frame: 1. month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05370131.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.