NCT07612124

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

May 21, 2026

Last Update Submit

May 21, 2026

Conditions

Keywords

Smart applicationTelemedicinePeritoneal dialysis

Outcome Measures

Primary Outcomes (2)

  • Unplanned Readmission Rate

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

    12 months

  • Peritonitis Incidence

    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.

    12 months

Study Arms (2)

Conventional Follow-up Group

ACTIVE COMPARATOR

Participants in this group receive conventional follow-up care. Healthcare providers organize a WeChat group to regularly post peritoneal dialysis health knowledge and answer patients' questions. Traditional telephone calls are used for follow-up reminders. In addition, participants attend routine peritoneal dialysis specialty clinic follow-up visits once every 3 months for 12 months, including physical examination, PD catheter exit site examination, collection of blood/urine/peritoneal fluid samples, external tubing replacement every 6 months, and personalized health education.

Other: Conventional Follow-up

Smart Application Follow-up Group

EXPERIMENTAL

Participants in this group receive follow-up care via a smart application named "Weiyin Health". The application provides functions including data collection, AI-based one-on-one Q\&A, follow-up reminders, and risk alerts. In addition, participants attend routine peritoneal dialysis specialty clinic follow-up visits once every 3 months for 12 months, including physical examination, PD catheter exit site examination, collection of blood/urine/peritoneal fluid samples, external tubing replacement every 6 months, and personalized health education.

Device: Weiyin Health Smart Application

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.

Conventional Follow-up Group

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.

Also known as: Weiyin Health APP
Smart Application Follow-up Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
None (Open Label)
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Pharmacist

Study Record Dates

First Submitted

May 21, 2026

First Posted

May 28, 2026

Study Start

July 1, 2024

Primary Completion

December 31, 2025

Study Completion

April 1, 2026

Last Updated

May 28, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations