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

NCT06524986 | Completed DMC

• 1 other identifier: 0814/65
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nephrotic Syndrome in Children

Keywords

Nephrotic Syndrome; Proteinuria; School-Age Children; Self-Efficacy; Computer Game

Outcome Measures

Primary Outcomes (1)

• Protein levels in the urine

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

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

Study Arms (2)

Self-efficacy promoting program

EXPERIMENTAL

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

Standard nursing care

EXPERIMENTAL

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

Self-efficacy promoting program using computer game BEHAVIORAL

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

Self-efficacy promoting program

Standard nursing care BEHAVIORAL

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.

Standard nursing care

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of Nursing, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (6)

• 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.

  PMID: 30999886 RESULT

• 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.

  PMID: 29531933 RESULT

• 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.

  PMID: 33206054 RESULT

• 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.

  PMID: 37090998 RESULT

• 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.

  PMID: 28914167 RESULT

• 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.

  PMID: 32866504 RESULT

MeSH Terms

Conditions

Nephrotic Syndrome; Proteinuria

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suwimon Rojnawee, Ph.D.

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: March 1, 2023
• Primary Completion: April 30, 2023
• Study Completion: July 30, 2023
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)