NCT05766644

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2023

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

February 27, 2023

Last Update Submit

March 9, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • Depression

    55 days

  • Insomnia

    48 days

  • Sodium intake behavior

    0 days

  • Sodium intake attitude

    0 days

  • Creatinine

    56 days

Study Arms (2)

Control

NO INTERVENTION

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

Education

EXPERIMENTAL

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

Interventions

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.

Education

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with CKD Stage 1\~5
  • Have been receiving CKD treatment for more than 6 months
  • Owns an android mobile phone

You may not qualify if:

  • Diagnosed with cancer within 5 years of recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University Seoul Paik Hospital

Seoul, 100-032, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Hoseok Koo

    Inje University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 13, 2023

Study Start

October 27, 2022

Primary Completion

February 6, 2023

Study Completion

October 6, 2023

Last Updated

March 13, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations