The Impact of Mobile APP Intervention ( iCKD APP) on Chronic Kidney Disease Care

August 31, 2021 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

The Impact of Mobile APP Intervention ( iCKD APP) on Chronic Kidney Disease Care: A Multicenter, Randomized, Open, Controlled Trial

  • Apply Mobile APP Intervention ( iCKD APP) to current chronic kidney disease care program.
  • Conduct a randomized clinical trial to evaluate the clinical effectiveness of this mobile device on health behavior improvement in chronic kidney disease patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A mHealth app (iCKD APP) was designed to assist CKD patients to monitor their home bio-information data. Patients will be randomly assigned into the iCKD APP group(intervention) and traditional care group (control). Participants will be randomized into an 1:1 manner (intervention : control). Random assignment occurred after the consent and initial enrollment interview. Individuals randomized to the iCKD APP will provide with the equipment after randomization. Participants will follow for at least 6 months before the exit interview.

Study Type

Interventional

Enrollment (Actual)

101

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

  • Taiwan
      • Kaohsiung, Taiwan
        • Kaohsiung Medical University Chung-Ho Memorial 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

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects are 20 years old and above, Chinese speaking, and able and willing to provide informed consent.
  • Subjects own mobile devices such as cell phones and tablets.
  • Subjects were diagnosed with Chronic Kidney Diseases and were taking a single antihypertensive agent for more than three months or they are not receiving treatment but with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg.

Exclusion Criteria:

  • starting dialysis or having a kidney transplant (RRT)
  • participating in other interventional study
  • cognitively impaired
  • unable to give consent
  • life expectancy less than 1 year

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: iCKD APP Group
Use iCKD APP
Device: iCKD APP
Use iCKD APP to upload home bio-information data
NO_INTERVENTION: Traditional Care Group
Accept traditional care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare clinics and home blood pressure
Time Frame: 3 months
Systolic and diastolic blood pressure levels measured at both clinics and home will be compared between and within groups at various time points in study period.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of Blood pressure control target
Time Frame: 3 months
Achievement of Blood pressure control target will be compared between and within groups at various time points in study period.
3 months
The monitor rate of Home Blood pressure
Time Frame: 3 months
The monitor rate of Blood pressure at home will be compared between and within groups at various time points in study period.
3 months

Collaborators and Investigators

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

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Study Chair: Shang-Jyh Hwang, Kaohsiung Medical University Chung-Ho Memorial Hospital

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)

June 26, 2018

Primary Completion (ACTUAL)

August 31, 2020

Study Completion (ACTUAL)

August 31, 2020

Study Registration Dates

First Submitted

August 7, 2018

First Submitted That Met QC Criteria

August 26, 2018

First Posted (ACTUAL)

August 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-F(II)-20180055

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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