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.
研究概览
详细说明
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
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Hunan
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Changsha、Hunan、中国、410013
- Third Xiangya Hospital of Central South University
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器: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.
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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.
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实验性的: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.
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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.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Unplanned Readmission Rate
大体时间:12 months
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The proportion of participants who experience unplanned hospital readmission during the 12-month follow-up period.
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12 months
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Peritonitis Incidence
大体时间:12 months
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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.
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12 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2024167
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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