App-based Education Program for CKD

March 9, 2023 updated by: Hoseok Koo, Inje University

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 100-032
        • Inje University Seoul Paik Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (SF-36v2)
Time Frame: 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)
48 days
MIS
Time Frame: 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)
55 days
Potassium
Time Frame: 56 days
Serum potassium levels obtained from routine blood test.
56 days
Phosphate
Time Frame: 56 days
Serum phosphate levels obtained from routine blood test.
56 days
Albumin
Time Frame: 56 days
Serum albumin levels obtained from routine blood test.
56 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: 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).
55 days
Insomnia
Time Frame: 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)
48 days
Sodium intake behavior
Time Frame: 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).
0 days
Sodium intake attitude
Time Frame: 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).
0 days
Creatinine
Time Frame: 56 days
Creatinine levels obtained from routine blood test.
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Collaborators

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

Investigators

  • Principal Investigator: Hoseok Koo, Inje University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2022

Primary Completion (Actual)

February 6, 2023

Study Completion (Anticipated)

October 6, 2023

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beans_CKD Education 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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