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App-based Education Program for CKD

Primary Purpose

Renal Insufficiency, Chronic

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Education
Sponsored by
Inje University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Renal Insufficiency, Chronic

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Inje University Seoul Paik Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Education

Arm Description

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

Enrolled in a mobile app-based education program, with guidance from a healthcare professional. All educational materials and surveys are provided via the app.

Outcomes

Primary Outcome Measures

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)
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)
Potassium
Serum potassium levels obtained from routine blood test.
Phosphate
Serum phosphate levels obtained from routine blood test.
Albumin
Serum albumin levels obtained from routine blood test.

Secondary Outcome Measures

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).
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)
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).
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).
Creatinine
Creatinine levels obtained from routine blood test.

Full Information

First Posted
February 27, 2023
Last Updated
March 9, 2023
Sponsor
Inje University
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT05766644
Brief Title
App-based Education Program for CKD
Official Title
Open-label, Randomized Comparative Clinical Trial on the Clinical Effect of App-based Education Program in Patients With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
February 6, 2023 (Actual)
Study Completion Date
October 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care, with no guide on app use. Surveys are administered via Short Message Services links.
Arm Title
Education
Arm Type
Experimental
Arm Description
Enrolled in a mobile app-based education program, with guidance from a healthcare professional. All educational materials and surveys are provided via the app.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Life (SF-36v2)
Description
36-Item Short Form Health Survey, version 2. Scores range from 0 to 100, higher value corresponding to better outcome (better quality of life)
Time Frame
48 days
Title
MIS
Description
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)
Time Frame
55 days
Title
Potassium
Description
Serum potassium levels obtained from routine blood test.
Time Frame
56 days
Title
Phosphate
Description
Serum phosphate levels obtained from routine blood test.
Time Frame
56 days
Title
Albumin
Description
Serum albumin levels obtained from routine blood test.
Time Frame
56 days
Secondary Outcome Measure Information:
Title
Depression
Description
21-item depression score measured with Korean-Beck Depression Inventory. Scores range from 0 to 63, higher value corresponding to worse outcome (severe depression).
Time Frame
55 days
Title
Insomnia
Description
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)
Time Frame
48 days
Title
Sodium intake behavior
Description
15-item sodium intake behavior score. Scores range from 0 to 15, higher values corresponding to worse outcome (higher tendency to prefer salty food).
Time Frame
0 days
Title
Sodium intake attitude
Description
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).
Time Frame
0 days
Title
Creatinine
Description
Creatinine levels obtained from routine blood test.
Time Frame
56 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoseok Koo
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Seoul Paik Hospital
City
Seoul
ZIP/Postal Code
100-032
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

App-based Education Program for CKD

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