- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07162220
- Original Trial
The Effect of a Mobile Game Application on Children With CRF
The Effect of a Mobile Game Application Developed for Children With Chronic Renal Failure on Disease Management
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Konyaaltı
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Antalya, Konyaaltı, Turkey (Türkiye), 07070
- Akdeniz University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- (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.
Exclusion Criteria:
- (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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Routine application
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.
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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.
|
|
Experimental: Intervention
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure
Time Frame: 3 months
|
3 months
|
|
|
BMI
Time Frame: 3 months
|
BMI in kg/m^2
|
3 months
|
|
Pulse rate
Time Frame: 3 months
|
3 months
|
|
|
Level of knowledge regarding chronic renal failure
Time Frame: 3 months
|
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.
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3 months
|
|
Healthy Lifestyle Belief Level for Adolescents
Time Frame: 3 months
|
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.
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3 months
|
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Child's Attitude Towards Their Own Illness
Time Frame: 3 months
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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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Mental Disorders
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Disruptive, Impulse Control, and Conduct Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Risk-Taking
- Disease
- Kidney Failure, Chronic
- Gambling
Other Study ID Numbers
- CRF_2022/04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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