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NCT03649516 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03649516
Other study ID # KMUHIRB-F(II)-20180055
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 26, 2018
Est. completion date August 31, 2020

Study information
Verified date August 2019
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 101
Est. completion date August 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• iCKD APP
Use iCKD APP to upload home bio-information data

Locations
Country Name City State
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compare clinics and home blood pressure 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 Achievement of Blood pressure control target Achievement of Blood pressure control target will be compared between and within groups at various time points in study period. 3 months
Secondary The monitor rate of Home Blood pressure The monitor rate of Blood pressure at home will be compared between and within groups at various time points in study period. 3 months
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