App-based Education Program for CKD

Study Overview
=================
Brief Summary
-----------------
A randomized control trial to test the effect of a mobile app-based educational program for Chronic Kidney Disease patients.

Official Title
-----------------
Open-label, Randomized Comparative Clinical Trial on the Clinical Effect of App-based Education Program in Patients With Chronic Kidney Disease

Conditions
-----------------
Renal Insufficiency, Chronic

Intervention / Treatment
-----------------
* Other: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with CKD Stage 1 5 Have been receiving CKD treatment for more than 6 months Owns an android mobile phone Exclusion Criteria: Diagnosed with cancer within 5 years of recruitment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care, with no guide on app use. Surveys are administered via Short Message Services links. | |
| Experimental: Education<br>Enrolled in a mobile app-based education program, with guidance from a healthcare professional. All educational materials and surveys are provided via the app. | Other: Education<br>* An 8-week program providing educational materials via a mobile app for chronic kidney disease management. Materials consist of videos, card news, and live online seminars with a Q&A session. Topics are on general disease information, nutrition, and exercise.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (SF-36v2) | 36-Item Short Form Health Survey, version 2. Scores range from 0 to 100, higher value corresponding to better outcome (better quality of life) | 48 days | 
| MIS | 10-item nutritional status measured with Malnutrition Inflammation Score. Scores range from 0 to 30, higher value corresponding to worse outcome (higher risk of malnutrition) | 55 days | 
| Potassium | Serum potassium levels obtained from routine blood test. | 56 days | 
| Phosphate | Serum phosphate levels obtained from routine blood test. | 56 days | 
| Albumin | Serum albumin levels obtained from routine blood test. | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | 21-item depression score measured with Korean-Beck Depression Inventory. Scores range from 0 to 63, higher value corresponding to worse outcome (severe depression). | 55 days | 
| Insomnia | 7-item insomnia score measured with Insomnia Severity Index in Korean. Scores range from 0 to 28, higher value corresponding to worse outcome (severe insomnia) | 48 days | 
| Sodium intake behavior | 15-item sodium intake behavior score. Scores range from 0 to 15, higher values corresponding to worse outcome (higher tendency to prefer salty food). | 0 days | 
| Sodium intake attitude | 17-item sodium intake attitude score. Scores range from 0 to 17, higher values correspond ing to better outcome (more willing to reduce sodium intake). | 0 days | 
| Creatinine | Creatinine levels obtained from routine blood test. | 56 days |