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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 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:
Exclusion Criteria:
Interventions:
Conventional Follow-up Group:
Smart Application Follow-up Group:
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:
Outcome Measures:
Primary Outcome Measures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Follow-up | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
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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.
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None (Open Label)
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| Weiyin Health Smart Application | Device | 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. |
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|
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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