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

Central South University

Status: Completed

Conditions: ESRD (End-Stage Renal Disease); Kidney Failure Chronic

Treatments: Other: Conventional Follow-up; Device: Weiyin Health Smart Application

Study type: Interventional

Funder types: Other

Identifiers

NCT07612124

2024167

Details and patient eligibility

About

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.

Full 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

Enrollment: 223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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223 participants in 2 patient groups

Conventional Follow-up Group

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Follow-up

Smart Application Follow-up Group

Experimental group

Description:

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.

Treatment:

Device: Weiyin Health Smart Application