Back to resultsThe Impact of Mobile APP Intervention ( iCKD APP) on Chronic Kidney Disease Care
Primary Purpose
Chronic Kidney Disease, Hypertension
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
iCKD APP
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Kidney Disease focused on measuring mHealth, Mobile application, Chronic Kidney Diseases
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
Sites / Locations
- Kaohsiung Medical University Chung-Ho Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
iCKD APP Group
Traditional Care Group
Arm Description
Use iCKD APP
Accept traditional care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03649516
First Posted
August 7, 2018
Last Updated
August 31, 2021
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03649516
Brief Title
The Impact of Mobile APP Intervention ( iCKD APP) on Chronic Kidney Disease Care
Official Title
The Impact of Mobile APP Intervention ( iCKD APP) on Chronic Kidney Disease Care: A Multicenter, Randomized, Open, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hypertension
Keywords
mHealth, Mobile application, Chronic Kidney Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iCKD APP Group
Arm Type
Experimental
Arm Description
Use iCKD APP
Arm Title
Traditional Care Group
Arm Type
No Intervention
Arm Description
Accept traditional care
Intervention Type
Device
Intervention Name(s)
iCKD APP
Intervention Description
Use iCKD APP to upload home bio-information data
Primary Outcome Measure Information:
Title
Compare clinics and home blood pressure
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Achievement of Blood pressure control target
Description
Achievement of Blood pressure control target will be compared between and within groups at various time points in study period.
Time Frame
3 months
Title
The monitor rate of Home Blood pressure
Description
The monitor rate of Blood pressure at home will be compared between and within groups at various time points in study period.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shang-Jyh Hwang
Organizational Affiliation
Kaohsiung Medical University Chung-Ho Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of Mobile APP Intervention ( iCKD APP) on Chronic Kidney Disease Care
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