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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Kidney Disease, Hypertension

Intervention / Treatment
-----------------
* Device: iCKD APP


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iCKD APP Group<br>Use iCKD APP | Device: iCKD APP<br>* Use iCKD APP to upload home bio-information data<br>|
| No Intervention: Traditional Care Group<br>Accept traditional care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mHealth, Mobile application, Chronic Kidney Diseases