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OpenTrials
Completed

NCT Number: NCT07612124

Evaluation of the Application of Intelligent Applications in Patients Undergoing Peritoneal Dialysis

The goal of this clinical trial is to evaluate the value of a smart application named "Weiyin Health" in the follow-up management of patients undergoing peritoneal dialysis. The main questions it aims to answer are:

Can the use of a smart application reduce the unplanned readmission rate?

Can the use of a smart application reduce the incidence of peritonitis?

Researchers will compare patients who use the smart application for follow-up with those who receive conventional follow-up.

Eligible patients on peritoneal dialysis will be randomly assigned to one of two groups: one group will receive conventional follow-up (WeChat group + telephone reminders), and the other group will use the "Weiyin Health" smart application for follow-up (including data collection, AI-based Q&A, follow-up reminders, and risk alerts). Both groups will attend peritoneal dialysis specialty clinic visits once every 3 months for routine check-ups over a 12-month period.

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Key information

About this study

Study Design:

This is a prospective, randomized, controlled, open-label study. Eligible patients on peritoneal dialysis will be randomized in a 1:1 ratio to either the conventional follow-up group or the smart application follow-up group. A total of 800 participants are planned for enrollment.

Eligibility Criteria:

Inclusion criteria

  • Age ≥ 18 years
  • Willing and able to provide signed informed consent
  • Receiving maintenance peritoneal dialysis
  • Has basic reading and comprehension skills and is able to use Internet-based tools such as WeChat

Exclusion criteria

  • History of peritonitis within the past 12 weeks, or active infection requiring systemic antibiotic therapy
  • Hospitalization within 4 weeks prior to screening
  • Severe heart failure (NYHA Class 4), severe malnutrition, malignancy, or any other condition that the investigator judges may affect the evaluation of outcomes
  • Currently participating in another clinical study
  • Psychiatric disorder or cognitive impairment

Interventions:

Conventional Follow-up Group:

  • Healthcare providers will organize a WeChat group for patients on peritoneal dialysis, regularly post peritoneal health knowledge in the group, and answer patients' questions in the group
  • Traditional telephone calls will be used for follow-up reminders

Smart Application Follow-up Group:

  • Patients will download and install the "Weiyin Health" application
  • The application provides the following functions:

Data collection AI-based one-on-one Q&A Follow-up reminders Risk alerts

Common Interventions (Both Groups):

All patients in both groups will attend routine peritoneal dialysis specialty clinic follow-up visits once every 3 months for 12 consecutive months. Follow-up include:

  • General assessment and physical examination
  • Examination of the PD catheter exit site
  • Collection of blood, urine, and peritoneal fluid samples
  • Replacement of the external tubing every 6 months
  • Personalized health education

Outcome Measures:

Primary Outcome Measures:

  • Unplanned readmission rate
  • Incidence of peritonitis

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1.Age ≥ 18 years 2.Willing and able to provide signed informed consent 3.Receiving maintenance peritoneal dialysis 4.Has basic reading and comprehension skills and is able to use Internet-based tools such as WeChat

Exclusion criteria

  • 1. History of peritonitis within the past 12 weeks, or active infection requiring systemic antibiotic therapy 2.Hospitalization within 4 weeks prior to screening 3.Severe heart failure (NYHA Class 4), severe malnutrition, malignancy, or any other condition that the investigator judges may affect the evaluation of outcomes 4.Currently participating in another clinical study 5.Psychiatric disorder or cognitive impairment

Treatment and study plan

Conventional follow-up

Other

Participants receive conventional follow-up care including a WeChat group for peritoneal dialysis health education and Q&A, and telephone reminders for follow-up visits.

Weiyin Health Smart Application

Device

A smart application installed on participants' mobile devices that provides functions including data collection, AI-based one-on-one Q&A, follow-up reminders, and risk alerts for peritoneal dialysis patients.

Other names: Weiyin Health APP

Primary outcomes

  1. Unplanned Readmission Rate

    Time frame: 12 months

    The proportion of participants who experience unplanned hospital readmission during the 12-month follow-up period.

  2. Peritonitis Incidence

    Time frame: 12 months

    The proportion of participants who develop peritonitis during the 12-month follow-up period. Peritonitis is defined according to the International Society for Peritoneal Dialysis (ISPD) criteria.

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 28, 2026
Registry last updated
May 28, 2026

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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