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

Not Applicable

Completed

• Conditions: Hypertension; Chronic Kidney Disease
• Interventions: Device: iCKD APP

• Registration Number: NCT03649516
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

* 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.

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 Timeline

• Study Start: 2018-06-26
• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-08-26
• Study First Posted: 2018-08-28
• Status Verified: 2019-08
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iCKD APP Group	iCKD APP	Use iCKD APP

Primary Outcome Measures

Name	Time	Method
Compare clinics and home blood pressure	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan