App-based Education Program for CKD

Sponsor

Inje University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05766644

Collaborator

Hallym University Kangnam Sacred Heart Hospital (Other), KangWon National University Hospital (Other), Korea University Guro Hospital (Other), Korea University Ansan Hospital (Other), Seoul National University (Other), Ministry of Health & Welfare, Korea (Other)

129

Enrollment

Location

Arms

11.3

Anticipated Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency, Chronic	Other: Education	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

129 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 27, 2022

Actual Primary Completion Date :

Feb 6, 2023

Anticipated Study Completion Date :

Oct 6, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Usual care, with no guide on app use. Surveys are administered via Short Message Services links.
Experimental: Education 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 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.

Arm

Intervention/Treatment

No Intervention: Control

Usual care, with no guide on app use. Surveys are administered via Short Message Services links.

Experimental: Education

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

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.

Outcome Measures

Primary Outcome Measures

Quality of Life (SF-36v2) [48 days]
36-Item Short Form Health Survey, version 2. Scores range from 0 to 100, higher value corresponding to better outcome (better quality of life)
MIS [55 days]
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)
Potassium [56 days]
Serum potassium levels obtained from routine blood test.
Phosphate [56 days]
Serum phosphate levels obtained from routine blood test.
Albumin [56 days]
Serum albumin levels obtained from routine blood test.

Secondary Outcome Measures

Depression [55 days]
21-item depression score measured with Korean-Beck Depression Inventory. Scores range from 0 to 63, higher value corresponding to worse outcome (severe depression).
Insomnia [48 days]
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)
Sodium intake behavior [0 days]
15-item sodium intake behavior score. Scores range from 0 to 15, higher values corresponding to worse outcome (higher tendency to prefer salty food).
Sodium intake attitude [0 days]
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).
Creatinine [56 days]
Creatinine levels obtained from routine blood test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inje University Seoul Paik Hospital	Seoul		Korea, Republic of	100-032

Sponsors and Collaborators

Inje University
Hallym University Kangnam Sacred Heart Hospital
KangWon National University Hospital
Korea University Guro Hospital
Korea University Ansan Hospital
Seoul National University
Ministry of Health & Welfare, Korea

Investigators

Principal Investigator: Hoseok Koo, Inje University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoseok Koo, Director, Inje University

ClinicalTrials.gov Identifier:

NCT05766644

Other Study ID Numbers:

Beans_CKD Education 1.0

First Posted:

Mar 13, 2023

Last Update Posted:

Mar 13, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Renal Insufficiency

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Mar 13, 2023