ESRD (End-Stage Renal Disease), Kidney Failure Chronic
Conditions
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.
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Unplanned Readmission Rate | 12 months | The proportion of participants who experience unplanned hospital readmission during the 12-month follow-up period. |
| Peritonitis Incidence | 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. |
Countries
China