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OpenTrials
Completed

NCT Number: NCT03649516

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

* 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.

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Key information

Conditions

Chronic Kidney Disease Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iCKD APP

Device

Use iCKD APP to upload home bio-information data

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2018
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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