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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07612124
Enrollment
223
Registered
2026-05-28
Start date
2024-07-01
Completion date
2026-04-01
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ESRD (End-Stage Renal Disease), Kidney Failure Chronic

Keywords

Smart application, Telemedicine, Peritoneal dialysis

Brief summary

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.

Detailed description

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: 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 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: 1. General assessment and physical examination 2. Examination of the PD catheter exit site 3. Collection of blood, urine, and peritoneal fluid samples 4. Replacement of the external tubing every 6 months 5. Personalized health education Outcome Measures: Primary Outcome Measures: 1. Unplanned readmission rate 2. Incidence of peritonitis

Interventions

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.

DEVICEWeiyin Health Smart Application

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.

Sponsors

The Third Xiangya Hospital of Central South University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

None (Open Label)

Intervention model description

Participants are randomly assigned in a 1:1 ratio to one of two parallel groups: the conventional follow-up group or the smart application follow-up group.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Unplanned Readmission Rate12 monthsThe proportion of participants who experience unplanned hospital readmission during the 12-month follow-up period.
Peritonitis Incidence12 monthsThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026