Nephrotic SyndromeNCT05904197
Effectiveness of Educational Gamified Cards About Nephrotic Syndrome
A study testing Gamified Cards about Nephrotic Syndrome in people with Nephrotic Syndrome, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effectiveness of educational innovative gamified cards about nephrotic syndrome for school age children on their outcomes and caregivers' practices Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- Gamified Cards about Nephrotic Syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 30 Nov 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with confirmed diagnosis of NS.
- School age child aged between 7 to 12 years old of both gender
Who cannot join
- Children with associated congenital anomalies.
- Children with mental retardation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Educational Innovative Gamified Cards About Nephrotic Syndrome for School Age Children on Their Outcomes and Caregivers' Practices
This study aims to evaluate the effectiveness of educational innovative gamified cards about nephrotic syndrome for school age children on their outcomes and caregivers' practices
Read the detailed description
Nephrotic Syndrome (NS) is the most common glomerular disorder in children, globally. Eighty percent of NS cases occur in preschool-aged children (less than 6 years of age). The ratio between boys and girls is approximately 2 to 1. It requires long-term treatment and can be recurrent. Steroid responsiveness is one of the critical determinants of the disease course. It has been reported to be 5% for steroid-sensitive NS and 40%-50% for steroid-resistant NS. Although up to approximately 85% of pediatric NS, patients are reportedly sensitive to steroids, most cases relapse, with around half having frequent relapses or becoming steroid-dependent. NS not only compromises the physical health of patients but also affects their psychological health, daily functioning, general well-being, and social functioning. Children with NS are not happy and not satisfied with their lives when compared with their healthy peers. Furthermore, corticosteroid (CS) therapy can cause behavioral abnormalities in children with NS. There was a strong positive correlation between using CS therapy for a long period and the development of psychiatric disorders such as aggression, anxiety, and depression.
Children with NS have unique nutrition support needs. Children should follow a healthy, age-appropriate diet to meet energy requirements and the daily recommended intake of protein. It is recommended to continue to limit sodium, saturated, and trans-saturated fat; as these have been linked to inflammation. Standardized diet recommendations are needed for the regulation of daily energy, sodium, calcium, and vitamin D intakes. Also, the management of the associated conditions and side effects of corticosteroid treatment should be considered. Studies on self-care in childhood NS are very few especially in developing countries (Eid et al, 2020; Rousselet al., 2019). Child education and self-care empowerment are key, which involve both the ability to care for oneself and the activities necessary to achieve, maintain, or promote one's optimal health. Through self-care, various outcomes may be achieved; for example, improved symptom control, coping with the illness, and quality of life (QoL).
In recent years, there has been a lot of attention given to the trend of including game elements in non-gaming facilities. The usage of gamification in education is a massive benefit for motivation, user interaction, and social effects. Gamification is recognized and implemented in diverse areas such as marketing, politics, industry, information technology, fitness exercise, and health . Health researchers and providers have started using gamification apps to deliver medical education online and through mobile apps. Many studies defined the technical term "gamification", it is a mechanism by which game design components are implemented in non-game environments. There are different studies on educational programs that prove the effectiveness of using technologies and gamification with children to promote healthy habits in the short term. Using game-based education, children experience opportunities to solve problems through analytical thinking and improve specific skills through training and adequate feedback. Engagement is also essential for programs designed to promote healthy behaviors.
The nursing role of a child with NS includes relief from edema, enhanced nutritional status, conservation energy, supplying sufficient information about the disease, considering the importance of compliance with the medication and nutritional therapy, and prevention of infection as well as relapse. The nursing Insufficient knowledge, poor compliance to medications, and health-related advice have diverse effects on children with NS including frequent relapse, drug toxicity, higher rates of complications, increased healthcare cost of NS, and high morbidity and mortality rates. In this study, we use empowering school-age children's and their caregivers' education through gamification to support children's self-care.
- Conditions
- Nephrotic Syndrome
- Being tested
- Gamified Cards about Nephrotic Syndrome
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified Cards about Nephrotic SyndromeOther
Also called Spin to Win - Nephro Cards
- The study intervention "Spin to Win - Nephro Cards" will include the following items with simple Arabic language and graphic designation appropriate to children's developmental levels including; nephrotic syndrome, hygiene practices, weight control, fluids, blood pressure control, diet, medication…etc.
- A spin wheel with numbers and images similar to the educational gamified cards will be designed. Children will request to spin the wheel. After the spin, the educational gamified "Nephro Cards" will reveal and discuss with the child.
| Study group | Role | What they receive |
|---|---|---|
| School age children with nephrotic syndrome and their Caregivers | Other | Children with NS will be expected to have higher knowledge scores about nephrotic syndrome post-intervention than pre-intervention.
Children with NS will be expected to have higher scores in healthcare-related practices including higher medication adherence post-intervention than pre-intervention.
Children with NS will be expected to have lower psychosocial problems post-intervention than pre-intervention.
Caregivers of children with NS will be expected to have higher knowledge scores about nephrotic syndrome post-intervention than pre-intervention.
Caregivers of children with NS will be expected to have higher scores in health care-related practices post-intervention than pre-intervention. Receives: Other: Gamified Cards about Nephrotic Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's knowledge related to nephrotic syndrome interview questionnaire sheet pre/posttest/ follow-up
This tool will be developed by the researcher in the Arabic language after reviewing the recent related literature to assess the nephrotic children's knowledge related to nephrotic syndrome including the definition of disease, causes, signs and symptoms, nephrotic syndrome specific diet, early signs of infection, oral medication and side effect…etc.
Measured: through study completion, an average of 6 months.
Children's self-reported health-related practices interview questionnaire sheet pre/posttest/ follow-up
This tool will be developed by the researcher in the Arabic language after reviewing the recent related literature to assess the nephrotic children's practices and will cover their reported practices regarding management of NS such as general hygiene practices, regular follow-up measures such as (measuring weight, intake and output, measuring temperature, blood pressure and check protein in urine), administration of medication, proper following of nutrition,.. etc.
Measured: through study completion, an average of 6 months.
Caregivers' knowledge related to nephrotic syndrome interview questionnaire sheet pre/posttest/ follow-up
This tool will be developed by the researcher in the Arabic language after reviewing the recent related literature to assess the nephrotic children's caregivers' knowledge related to nephrotic syndrome this part will include questions about the nature of the disease, its causes and clinical features, drug administration and its side effects, diet, prevention of infections, urine examination at home, related activities and follow up.
Measured: through study completion, an average of 6 months.
Caregivers' self-reported health-related practices interview questionnaire sheet pre/posttest/ follow-up
This tool will be developed by the researcher in the Arabic language after reviewing the recent related literature to assess the nephrotic children's caregivers' practices and will cover their reported practices regarding the management of NS and will be consisted of questions to assess reported practices of caregivers regarding home management of children with NS. This section will include questions regarding practices of the caregivers in situations when the child responds to therapy, receive corticosteroids and has edema or respiratory infections, regular follow-up measures such as (measuring weight, intake and output, measuring temperature, blood pressure and check protein in urine), administration of medication, proper following of nutrition instructions,.. etc.
Measured: through study completion, an average of 6 months.
The Pediatric Symptom Checklist-17 (Psc-17) pre / follow up
It is a psychosocial screen checklist designed to facilitate the recognition of cognitive, emotional behavioral problems. 'The PSC-17 consists of 17 items that are rated as "Never", "Sometimes" or "Often". The PSC helps evaluate how the child is functioning at home, at school, with friends and family, and during other activities in terms of mood and behavior. The PSC helps evaluate how the child is functioning at home, at school, with friends and family, and during other activities in terms of mood and behavior.Caregivers will fill out this tool on behalf of their children
Measured: through study completion, an average of 6 months.
Adherence to Refills and Medications Scale (ARMS) pre / follow up
A validated Arabic version of ARMS will be adopted its 12-item self-reported medication adherence scale consists of two subscales (adherence with filling medications and adherence with taking medications). The adherence with filling medications subscale consists of four items, and the remaining eight items comprise the other subscale (adherence with taking medications).
Measured: through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jun 2024
- Primary completion1 Jun 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A quasi-experimental (one-group pretest-posttest)
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mustafa Hamza Taha, Mansoura University
- Investigators
- Fawzia Abusaad, Prof, Principal investigator, Faculty of Nursing, Mansoura University, Egypt Republik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904197
- Sponsor's protocol ID
- Gamified Health Education
- Status last verified
- Apr 2025
- First submitted
- 27 May 2023
- Last updated
- 22 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhimin L. Self-care in Chinese school-age children with nephrotic syndrome. MCN Am J Matern Child Nurs. 2003 Mar-Apr;28(2):81-5. doi: 10.1097/00005721-200303000-00008.
PubMed 12629312Krishnamurthy K, Selvaraj N, Gupta P, Cyriac B, Dhurairaj P, Abdullah A, Krishnapillai A, Lugova H, Haque M, Xie S, Ang ET. Benefits of gamification in medical education. Clin Anat. 2022 Sep;35(6):795-807. doi: 10.1002/ca.23916. Epub 2022 Jun 8.
PubMed 35637557
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Educational Innovative Gamified Cards About Nephrotic Syndrome for School Age Children on Their Outcomes and Caregivers' Practices
- ClinicalTrials.gov ID
- NCT05904197
- Acronym / sponsor ID
- Gamified Health Education
- Conditions
- Nephrotic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 15 Jun 2023 (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.
This study aims to evaluate the effectiveness of educational innovative gamified cards about nephrotic syndrome for school age children on their outcomes and caregivers' practices
Detailed description
Nephrotic Syndrome (NS) is the most common glomerular disorder in children, globally. Eighty percent of NS cases occur in preschool-aged children (less than 6 years of age). The ratio between boys and girls is approximately 2 to 1. It requires long-term treatment and can be recurrent. Steroid responsiveness is one of the critical determinants of the disease course. It has been reported to be 5% for steroid-sensitive NS and 40%-50% for steroid-resistant NS. Although up to approximately 85% of pediatric NS, patients are reportedly sensitive to steroids, most cases relapse, with around half having frequent relapses or becoming steroid-dependent. NS not only compromises the physical health of patients but also affects their psychological health, daily functioning, general well-being, and social functioning. Children with NS are not happy and not satisfied with their lives when compared with their healthy peers. Furthermore, corticosteroid (CS) therapy can cause behavioral abnormalities in children with NS. There was a strong positive correlation between using CS therapy for a long period and the development of psychiatric disorders such as aggression, anxiety, and depression.
Children with NS have unique nutrition support needs. Children should follow a healthy, age-appropriate diet to meet energy requirements and the daily recommended intake of protein. It is recommended to continue to limit sodium, saturated, and trans-saturated fat; as these have been linked to inflammation. Standardized diet recommendations are needed for the regulation of daily energy, sodium, calcium, and vitamin D intakes. Also, the management of the associated conditions and side effects of corticosteroid treatment should be considered. Studies on self-care in childhood NS are very few especially in developing countries (Eid et al, 2020; Rousselet al., 2019). Child education and self-care empowerment are key, which involve both the ability to care for oneself and the activities necessary to achieve, maintain, or promote one's optimal health. Through self-care, various outcomes may be achieved; for example, improved symptom control, coping with the illness, and quality of life (QoL).
In recent years, there has been a lot of attention given to the trend of including game elements in non-gaming facilities. The usage of gamification in education is a massive benefit for motivation, user interaction, and social effects. Gamification is recognized and implemented in diverse areas such as marketing, politics, industry, information technology, fitness exercise, and health . Health researchers and providers have started using gamification apps to deliver medical education online and through mobile apps. Many studies defined the technical term "gamification", it is a mechanism by which game design components are implemented in non-game environments. There are different studies on educational programs that prove the effectiveness of using technologies and gamification with children to promote healthy habits in the short term. Using game-based education, children experience opportunities to solve problems through analytical thinking and improve specific skills through training and adequate feedback. Engagement is also essential for programs designed to promote healthy behaviors.
The nursing role of a child with NS includes relief from edema, enhanced nutritional status, conservation energy, supplying sufficient information about the disease, considering the importance of compliance with the medication and nutritional therapy, and prevention of infection as well as relapse. The nursing Insufficient knowledge, poor compliance to medications, and health-related advice have diverse effects on children with NS including frequent relapse, drug toxicity, higher rates of complications, increased healthcare cost of NS, and high morbidity and mortality rates. In this study, we use empowering school-age children's and their caregivers' education through gamification to support children's self-care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A quasi-experimental (one-group pretest-posttest)
| Arm | Type | Receives |
|---|---|---|
| School age children with nephrotic syndrome and their Caregivers | Other | Other: Gamified Cards about Nephrotic SyndromeChildren with NS will be expected to have higher knowledge scores about nephrotic syndrome post-intervention than pre-intervention. Children with NS will be expected to have higher scores in healthcare-related practices including higher medication adherence post-intervention than pre-intervention. Children with NS will be expected to have lower psychosocial problems post-intervention than pre-intervention. Caregivers of children with NS will be expected to have higher knowledge scores about nephrotic syndrome post-intervention than pre-intervention. Caregivers of children with NS will be expected to have higher scores in health care-related practices post-intervention than pre-intervention. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with confirmed diagnosis of NS.
- School age child aged between 7 to 12 years old of both gender
Key exclusion criteria (2 listed)
- Children with associated congenital anomalies.
- Children with mental retardation.
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 |
|---|---|---|
| Gamified Cards about Nephrotic SyndromeAlso: Spin to Win - Nephro Cards* The study intervention "Spin to Win - Nephro Cards" will include the following items with simple Arabic language and graphic designation appropriate to children's developmental levels including; nephrotic syndrome, hygiene practices, weight control, fluids, blood pressure control, diet, medication…etc. * A spin wheel with numbers and images similar to the educational gamified cards will be designed. Children will request to spin the wheel. After the spin, the educational gamified "Nephro Cards" will reveal and discuss with the child. | Other | School age children with nephrotic syndrome and their Caregivers |
Primary outcome
Children's knowledge related to nephrotic syndrome interview questionnaire sheet pre/posttest/ follow-up
Time frame: through study completion, an average of 6 months.
This tool will be developed by the researcher in the Arabic language after reviewing the recent related literature to assess the nephrotic children's knowledge related to nephrotic syndrome including the definition of disease, causes, signs and symptoms, nephrotic syndrome specific diet, early signs of infection, oral medication and side effect…etc.
Children's self-reported health-related practices interview questionnaire sheet pre/posttest/ follow-up
Time frame: through study completion, an average of 6 months.
This tool will be developed by the researcher in the Arabic language after reviewing the recent related literature to assess the nephrotic children's practices and will cover their reported practices regarding management of NS such as general hygiene practices, regular follow-up measures such as (measuring weight, intake and output, measuring temperature, blood pressure and check protein in urine), administration of medication, proper following of nutrition,.. etc.
Caregivers' knowledge related to nephrotic syndrome interview questionnaire sheet pre/posttest/ follow-up
Time frame: through study completion, an average of 6 months.
This tool will be developed by the researcher in the Arabic language after reviewing the recent related literature to assess the nephrotic children's caregivers' knowledge related to nephrotic syndrome this part will include questions about the nature of the disease, its causes and clinical features, drug administration and its side effects, diet, prevention of infections, urine examination at home, related activities and follow up.
Caregivers' self-reported health-related practices interview questionnaire sheet pre/posttest/ follow-up
Time frame: through study completion, an average of 6 months.
This tool will be developed by the researcher in the Arabic language after reviewing the recent related literature to assess the nephrotic children's caregivers' practices and will cover their reported practices regarding the management of NS and will be consisted of questions to assess reported practices of caregivers regarding home management of children with NS. This section will include questions regarding practices of the caregivers in situations when the child responds to therapy, receive corticosteroids and has edema or respiratory infections, regular follow-up measures such as (measuring weight, intake and output, measuring temperature, blood pressure and check protein in urine), administration of medication, proper following of nutrition instructions,.. etc.
The Pediatric Symptom Checklist-17 (Psc-17) pre / follow up
Time frame: through study completion, an average of 6 months.
It is a psychosocial screen checklist designed to facilitate the recognition of cognitive, emotional behavioral problems. 'The PSC-17 consists of 17 items that are rated as "Never", "Sometimes" or "Often". The PSC helps evaluate how the child is functioning at home, at school, with friends and family, and during other activities in terms of mood and behavior. The PSC helps evaluate how the child is functioning at home, at school, with friends and family, and during other activities in terms of mood and behavior.Caregivers will fill out this tool on behalf of their children
Adherence to Refills and Medications Scale (ARMS) pre / follow up
Time frame: through study completion, an average of 6 months.
A validated Arabic version of ARMS will be adopted its 12-item self-reported medication adherence scale consists of two subscales (adherence with filling medications and adherence with taking medications). The adherence with filling medications subscale consists of four items, and the remaining eight items comprise the other subscale (adherence with taking medications).
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 22 Apr 2025.
- Background: PubMed 12629312Zhimin L. Self-care in Chinese school-age children with nephrotic syndrome. MCN Am J Matern Child Nurs. 2003 Mar-Apr;28(2):81-5. doi: 10.1097/00005721-200303000-00008.
- Background: PubMed 35637557Krishnamurthy K, Selvaraj N, Gupta P, Cyriac B, Dhurairaj P, Abdullah A, Krishnapillai A, Lugova H, Haque M, Xie S, Ang ET. Benefits of gamification in medical education. Clin Anat. 2022 Sep;35(6):795-807. doi: 10.1002/ca.23916. Epub 2022 Jun 8.
- Individual participant dataSharing planned: No
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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.
Fawzia Abusaad, Prof principal investigator
Faculty of Nursing, Mansoura University, Egypt Republik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified Cards about Nephrotic Syndrome in people with Nephrotic Syndrome, run by Mansoura University at 1 site in Egypt.
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 2 inclusion and 2 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 22 Apr 2025. 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 Egypt. 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?
Children's knowledge related to nephrotic syndrome interview questionnaire sheet pre/posttest/ follow-up (time frame: through study completion, an average of 6 months.). The study lists 6 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 NCT05904197, which also lists 2 linked publications.
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 22 Apr 2025.