NCT07162220

Brief Summary

The aim of this study was to investigate the effect of a mobile game application developed for children with Chronic Renal Failure (CRF) on disease management. The study was a randomized controlled trial. The study sample consisted of 68 children diagnosed with CRF, including the Mobile application (n:34) and Control group (n:34). In the study, a mobile game was developed for children diagnosed with CRF aged 11-14 years. Data Collection Form, Clinical Parameters Follow-up Form, Information Form on Chronic Renal Failure, Healthy Lifestyle Belief Scale for Adolescents, Child's Attitude Toward His/her Disease Scale and Mobile Application Usability Scale were used to collect the data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

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

Study Start

First participant enrolled

May 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

August 23, 2025

Last Update Submit

September 5, 2025

Conditions

Keywords

chronic renal failurechildmobile gamedisease management

Outcome Measures

Primary Outcomes (6)

  • BMI

    BMI in kg/m\^2

    3 months

  • Blood pressure

    3 months

  • Pulse rate

    3 months

  • Level of knowledge regarding chronic renal failure

    The information form consists of 25 questions. The information form has been created with two answers, correct and incorrect. Correct answers are worth 1 point, while incorrect answers are worth 0 points, and the form is evaluated based on the total score. A reliability analysis was performed using Kuder Richardson 20 (KR-20) to evaluate whether the items that make up the question form form a whole.

    3 months

  • Healthy Lifestyle Belief Level for Adolescents

    The scale emphasizes beliefs related to various aspects of maintaining a healthy lifestyle. The scale has a total of 16 items. The scale has three subscales: health beliefs, physical activity, and nutrition. The health beliefs subscale is composed of items 4, 5, 6, 11, 12, 13, and 16; the physical activity subscale includes items 2, 7, 9, 14, and 15; and the nutrition subscale comprises items 1, 3, 8, and 10. The scale, prepared according to the five-point Likert system, is answered on a scale of "1=Strongly Disagree, 5=Strongly Agree." A minimum of 16 and a maximum of 80 points can be obtained from the entire scale. An increase in the score obtained from the scale indicates an increase in adolescents' belief in healthy living.

    3 months

  • Child's Attitude Towards Their Own Illness

    The Child's Attitude Toward Their Own Illness Scale is a 13-item measure developed to assess children's feelings and thoughts about having a chronic illness. Participants respond to the scale items using a 5-point Likert scale: "never, not often, sometimes, often, and very often." Items 1, 2, 3, 4, 5, 7, 9, 11, and 13 are reverse-coded. When evaluating the scale, the scores obtained from the 13 items are summed and divided by the number of items. The total score range is min: 1 to max: 5. Scores of 1 and 2 indicate a negative attitude, 3 indicates a neutral attitude, and 4 and 5 indicate a positive attitude.

    3 months

Study Arms (2)

Routine application

OTHER

No procedures outside of the clinic's routine were performed on the children in the control group. As part of the clinic's routine education program, information about kidney function, CKD, nutrition, exercise, medications, and stress management is provided verbally by a nephrology clinic nurse in approximately 20 minutes. The Chronic Kidney Disease Information Form, the Healthy Lifestyle Belief Scale for Adolescents, and the Child's Attitude Toward Their Own Illness Scale were administered to the children before the education program, after the program, and at the end of the first and third months, and the relevant clinical parameters were measured.

Other: The clinic's routine education program

Intervention

EXPERIMENTAL

A mobile game application was downloaded onto the phones of the children participating in the study group. Before starting the mobile game, after completing the application, and at the end of the first and third months, the Chronic Kidney Disease Information Form, the Healthy Lifestyle Belief Scale for Adolescents, and the Child's Attitude Toward Their Own Illness Scale were administered, and relevant clinical parameters were measured. At the end of the study, the Mobile Application Usability Scale was also administered.

Device: Mobile game app

Interventions

As part of the clinic's routine education program, information about kidney function, CKD, nutrition, exercise, medications, and stress management is provided verbally by a nephrology clinic nurse in approximately 20 minutes.

Routine application

The mobile game software developed for patients with chronic renal failure contains information for children on daily life activities such as nutrition, exercise, personal hygiene, etc.

Intervention

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • (a) 11-14 years old
  • (b) Being monitored with a diagnosis of Chronic Kidney Failure
  • (c) having the ability to read, write, and understand Turkish
  • (d) having a phone/tablet with mobile game download capability
  • (e) volunteering to participate in the study
  • (f) being willing to participate in the study.

You may not qualify if:

  • (a) having mental, neurological, or communication problems
  • (b) being on hemodialysis
  • (c) communication, mental or neurological problems
  • (d) being on peritoneal dialysis
  • (e) having previously attended planned training on CRF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

GamblingDiseaseKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease Attributes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
To control statistical bias, the data were transferred to a computer by an independent researcher, coded as groups A and B, and entered into the database. After the data were analyzed by a statistician and a statistical report was written, the control and research groups were reported by the coder.
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: A randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2025

First Posted

September 9, 2025

Study Start

May 1, 2024

Primary Completion

March 24, 2025

Study Completion

May 1, 2025

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations