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Nephrotic Syndrome in ChildrenNCT06524986

The Effect of Self-Efficacy Promoting Program Using Computer Game on Proteinuria in Thai Children With Nephrotic Syndrome

A study testing Self-efficacy promoting program using computer game and Standard nursing care in people with Nephrotic Syndrome in Children, run by Chulalongkorn University at 1 site in Thailand.

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

Nephrotic syndrome is a medical condition where the kidneys release substantial amounts of protein into the urine, resulting in various issues such as tissue swelling and an increased susceptibility to infections. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Nephrotic Syndrome in Children
What is being tested?
Self-efficacy promoting program using computer game and Standard nursing care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteThailand
Study dates
1 Mar 2023to 30 Jul 2023
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 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Confirmation of nephrotic syndrome diagnosis by a physician and continuous hospital treatment for a minimum of 3 months.
  • Presence of proteinuria levels at 1+ or higher during morning awakening or a urine protein quantity exceeding 30 mg/dL within the past 6 months (verified through medical records).
  • Proficient communication skills in the Thai language.
  • Ownership of a telephone or device suitable for gaming and internet connectivity.
  • Willingness and cooperation from both the family and the child to actively participate in the research.
  • Discontinuation of steroid medication by school-age patients.

Who cannot join

  • involve symptoms indicative of a critical condition, such as entering a crisis or severe complications like heart failure or pleural effusion.
  • school-age patients whose treatment plan has been modified by a physician, including the use of injectable medication instead of oral drugs or those receiving treatment in an inpatient setting.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Faculty of Nursing, Chulalongkorn University

    Pathum Wan, Bangkok, 10330

Other trials in Thailand

About this study

Nephrotic syndrome is a medical condition where the kidneys release substantial amounts of protein into the urine, resulting in various issues such as tissue swelling and an increased susceptibility to infections. Emphasizing the importance of adequate nutrition and symptom monitoring is crucial in managing urine protein levels and mitigating associated complications.

The purpose of this study was to boost self-efficacy through a computer game-based program, aiding pediatric patients with Nephrotic syndrome in the adoption of healthy eating habits and efficient management of urine protein levels.

Read the detailed description

This study was Quasi-experimental Research. Two group pre-test post-test with repeated measures design. Forty school-age children diagnosed with nephrotic syndrome were randomly allocated into two groups, with the participants distributed between an experimental group and a control group, each comprising 20 individuals. The experimental group underwent a program that aimed to enhance self-efficacy through computer games for a duration of 5 weeks, whereas the control group received regular nursing care. Information was gathered through personal record forms, urine protein assessments with test strips, dietary behavior surveys for school-age children with nephrotic symptoms, and self-efficacy surveys related to dietary behavior within the same group. The data underwent analysis using repeated measures analysis of variance. Statistical significance was defined as p < .05.

Being tested
Self-efficacy promoting program using computer game, Standard nursing care
Keywords
Nephrotic Syndrome, Proteinuria, School-Age Children, Self-Efficacy, Computer Game
Medical subject headings
Nephrotic Syndrome, Proteinuria

What participants receive

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

  • Self-efficacy promoting program using computer gameBehavioural

    The self-efficacy promotion program, inspired by Bandura's principles (1997, 2001) and employing computer games, extends across 5 weeks with 30-minute sessions conducted 10 minutes. Activities include: 1) Enactive Mastery Experiences 2) Modeling 3) Verbal Persuasion 4) Physiological and Affective States Assessment

  • Standard nursing careBehavioural

    The control group received standard nursing care, which included providing dietary recommendations for pediatric patients. The recommended daily intake consisted of 0.8 grams of protein per kilogram of the child's weight, low-sodium foods, and low-fat options. This personalized guidance was communicated through informational brochures.

Study groups in NCT06524986
Study groupRoleWhat they receive
Self-efficacy promoting programExperimentalThe self-efficacy promotion program, inspired by Bandura's principles (1997, 2001) and employing computer games, extends across 5 weeks with 30-minute sessions conducted 10 minutes.The program involved activities such as motivation, modeling, and enactive mastery experiences. Weekly sessions covered collaborative planning, video demonstrations, interactive gaming, and follow-up calls to ensure active participation and address concerns related to physiological and affective states.
Receives: Behavioral: Self-efficacy promoting program using computer game
Standard nursing careExperimentalThe control group received standard nursing care, which included providing dietary recommendations for pediatric patients. The recommended daily intake consisted of 0.8 grams of protein per kilogram of the child's weight, low-sodium foods, and low-fat options. This personalized guidance was communicated through informational brochures.
Receives: Behavioral: Standard nursing care

What is being measured

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

  1. Protein levels in the urine

    Urine dipstick test assessments with COMBI-SCREEN® GP test strips

    Measured: Change from Baseline Protein levels in the urine at 5 weeks, followed by three days of consecutive follow-up calls

Timeline

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

  1. First posted29 Jul 2024
  2. Study start1 Mar 2023
  3. Primary completion30 Apr 2023
  4. Study completion30 Jul 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The experimental group underwent a program that aimed to enhance self-efficacy through computer games for a duration of 5 weeks, whereas the control group received regular nursing care.
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06524986
Sponsor's protocol ID
0814/65
Status last verified
Jul 2024
First submitted
24 Jul 2024
Last updated
29 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Leddy J, Green JA, Yule C, Molecavage J, Coresh J, Chang AR. Improving proteinuria screening with mailed smartphone urinalysis testing in previously unscreened patients with hypertension: a randomized controlled trial. BMC Nephrol. 2019 Apr 18;20(1):132. doi: 10.1186/s12882-019-1324-z.

    PubMed 30999886

  • Jari M, Merrikhi A, Kelishadi R, Ghaffarzadeh Z. The First Report on the Frequency of Asymptomatic Proteinuria in Iranian School-aged Children. Adv Biomed Res. 2018 Feb 21;7:35. doi: 10.4103/2277-9175.225923. eCollection 2018.

    PubMed 29531933

  • Kato-Lin YC, Kumar UB, Sri Prakash B, Prakash B, Varadan V, Agnihotri S, Subramanyam N, Krishnatray P, Padman R. Impact of Pediatric Mobile Game Play on Healthy Eating Behavior: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Nov 18;8(11):e15717. doi: 10.2196/15717.

    PubMed 33206054

  • Mishra R, Kumari S, Pathak A, Prasad KN, Malakar J. Risk factors for relapse in pediatric nephrotic syndrome in Ranchi. J Family Med Prim Care. 2023 Feb;12(2):223-226. doi: 10.4103/jfmpc.jfmpc_983_22. Epub 2023 Feb 28.

    PubMed 37090998

  • Downie ML, Gallibois C, Parekh RS, Noone DG. Nephrotic syndrome in infants and children: pathophysiology and management. Paediatr Int Child Health. 2017 Nov;37(4):248-258. doi: 10.1080/20469047.2017.1374003. Epub 2017 Sep 15.

    PubMed 28914167

  • Esezobor C, Ademola AD, Adetunji AE, Anigilaje EA, Batte A, Jiya-Bello FN, Furia FF, Muoneke U, McCulloch M, Nourse P, Obiagwu P, Odetunde O, Okyere P, Solarin A, Tannor EK, Noone D, Gbadegesin R, Parekh RS; Human Hereditary and Health in Africa Kidney Disease Research Network. Management of idiopathic childhood nephrotic syndrome in sub-Saharan Africa: Ibadan consensus statement. Kidney Int. 2021 Jan;99(1):59-67. doi: 10.1016/j.kint.2020.07.045. Epub 2020 Aug 29. No abstract available.

    PubMed 32866504

Questions about this trial

What is this clinical trial studying?

A study testing Self-efficacy promoting program using computer game and Standard nursing care in people with Nephrotic Syndrome in Children, run by Chulalongkorn University at 1 site in Thailand.

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 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 29 Jul 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 Thailand. 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?

Protein levels in the urine (time frame: Change from Baseline Protein levels in the urine at 5 weeks, followed by three days of consecutive follow-up calls). 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 NCT06524986, which also lists 6 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 29 Jul 2024; AzTrials last refreshed its copy on 28 Oct 2026.

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