- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Intervention / Treatment
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:
- 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410013
- Third Xiangya Hospital of Central South University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Follow-up Group
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.
|
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.
|
|
Experimental: Smart Application Follow-up Group
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Unplanned Readmission Rate
Time Frame: 12 months
|
The proportion of participants who experience unplanned hospital readmission during the 12-month follow-up period.
|
12 months
|
|
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.
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Renal Insufficiency, Chronic
Other Study ID Numbers
- 2024167
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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