App-based Education Program for CKD

Renal Insufficiency, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05766644
• Other study ID #: Beans_CKD Education 1.0
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: October 6, 2023

Study information

• Verified date: March 2023
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: October 6, 2023
• Est. primary completion date: February 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Inje University Seoul Paik Hospital	Seoul

Sponsors (7)

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Potassium	Serum potassium levels obtained from routine blood test.	56 days
Primary	Phosphate	Serum phosphate levels obtained from routine blood test.	56 days
Primary	Albumin	Serum albumin levels obtained from routine blood test.	56 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Creatinine	Creatinine levels obtained from routine blood test.	56 days