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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649516
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Hypertension Device: iCKD APP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Impact of Mobile APP Intervention ( iCKD APP) on Chronic Kidney Disease Care: A Multicenter, Randomized, Open, Controlled Trial
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: iCKD APP Group
Use iCKD APP
Device: iCKD APP
Use iCKD APP to upload home bio-information data

No Intervention: Traditional Care Group
Accept traditional care



Primary Outcome Measures :
  1. Compare clinics and home blood pressure [ Time Frame: 3 months ]
    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 :
  1. Achievement of Blood pressure control target [ Time Frame: 3 months ]
    Achievement of Blood pressure control target will be compared between and within groups at various time points in study period.

  2. The monitor rate of Home Blood pressure [ Time Frame: 3 months ]
    The monitor rate of Blood pressure at home will be compared between and within groups at various time points in study period.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649516


Contacts
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Contact: Shang-Jyh Hwang +886-3121101 ext 7901 kmuckd7901@gmail.com
Contact: Pei-Ni Hsiao +886-3121101 ext 7901 ickdnini@gmail.com

Locations
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Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan
Contact: Shang-Jyh Hwang, MD         
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Study Chair: Shang-Jyh Hwang Kaohsiung Medical University Chung-Ho Memorial Hospital

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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT03649516    
Other Study ID Numbers: KMUHIRB-F(II)-20180055
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
mHealth
Mobile application
Chronic Kidney Diseases
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency