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

NCT ID: NCT03649516

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-26

Study Completion Date

2020-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

* 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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

iCKD APP Group

Use iCKD APP

Group Type EXPERIMENTAL

iCKD APP

Intervention Type DEVICE

Use iCKD APP to upload home bio-information data

Traditional Care Group

Accept traditional care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

iCKD APP

Use iCKD APP to upload home bio-information data

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shang-Jyh Hwang

Role: STUDY_CHAIR

Kaohsiung Medical University Chung-Ho Memorial Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KMUHIRB-F(II)-20180055

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Exercise on Renal Function in Predialysis
NCT02155036 COMPLETED PHASE1/PHASE2