NCT03649516

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2019

Enrollment Period

2.2 years

First QC Date

August 7, 2018

Last Update Submit

August 31, 2021

Conditions

Chronic Kidney DiseaseHypertension

Keywords

mHealthMobile applicationChronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Achievement of Blood pressure control target

    3 months

  • The monitor rate of Home Blood pressure

    3 months

Study Arms (2)

iCKD APP Group

EXPERIMENTAL

Use iCKD APP

Device: iCKD APP

Traditional Care Group

NO INTERVENTION

Accept traditional care

Interventions

iCKD APPDEVICE

Use iCKD APP to upload home bio-information data

iCKD APP Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicHypertension

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Study Officials

  • Shang-Jyh Hwang

    Kaohsiung Medical University Chung-Ho Memorial Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 28, 2018

Study Start

June 26, 2018

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

September 2, 2021

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)