ClinicalTrials.gg
CompletedNCT06524986Updated Jul 29, 2024

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

An interventional study of Self-efficacy promoting program using computer game and Standard nursing care in Nephrotic Syndrome in Children, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-07-29.

Sponsored by Chulalongkorn University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Mar 2023, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Nephrotic Syndrome in Children

Keywords

  • Nephrotic Syndrome
  • Proteinuria
  • School-Age Children
  • Self-Efficacy
  • Computer Game
03

In context

Nephrotic Syndrome

191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.

This study's enrollment of 40 is below the median of 46 across 122 interventional studies indexed under Nephrotic Syndrome.

Browse Nephrotic Syndrome studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 medication by school-age patients.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Self-efficacy promoting program

    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.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.

    Behavioral: Self-efficacy promoting program using computer game

  • Experimental
    Standard nursing care

    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.

    Behavioral: Standard nursing care

Interventions

  • BehavioralSelf-efficacy promoting program using computer game

    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

  • BehavioralStandard nursing care

    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.

06

What researchers measure

Primary outcomes

  1. Protein levels in the urine

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

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

07

Study locations

1 site
  • Faculty of Nursing, Chulalongkorn University
    Pathum Wan, Bangkok 10330, Thailand
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2023 to primary completion in Apr 2023, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2024
First posted
Jul 29, 2024
StartActual
Mar 1, 2023
Primary completionActual
Apr 30, 2023
CompletionActual
Jul 30, 2023
Last update
Jul 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06524986
Responsible party
Suwimon Rojnawee, PhD, RN (Principal investigator, Chulalongkorn University) — Principal investigator
First posted
Jul 29, 2024
Start date
Mar 1, 2023
Primary completion
Apr 30, 2023
Completion
Jul 30, 2023
Last update
Jul 29, 2024

Study contacts

Suwimon Rojnawee, Ph.D.
principal investigator · Chulalongkorn University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion