NCT05904197

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

Same day

First QC Date

May 27, 2023

Last Update Submit

April 18, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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

    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).

    through study completion, an average of 6 months.

Study Arms (1)

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.

Other: Gamified Cards about Nephrotic Syndrome

Interventions

* 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.

Also known as: Spin to Win - Nephro Cards
School age children with nephrotic syndrome and their Caregivers

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with confirmed diagnosis of NS.
  • School age child aged between 7 to 12 years old of both gender

You may not qualify if:

  • Children with associated congenital anomalies.
  • Children with mental retardation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing, Mansoura University, Egypt Republik

Al Mansurah, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 12629312BACKGROUND
  • Krishnamurthy 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.

    PMID: 35637557BACKGROUND

MeSH Terms

Conditions

Nephrotic Syndrome

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Fawzia Abusaad, Prof

    Faculty of Nursing, Mansoura University, Egypt Republik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: A quasi-experimental (one-group pretest-posttest)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

May 27, 2023

First Posted

June 15, 2023

Study Start

June 1, 2024

Primary Completion

June 1, 2024

Study Completion

November 30, 2024

Last Updated

April 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations