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.
調査の概要
詳細な説明
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
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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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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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Unplanned Readmission Rate
時間枠：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
時間枠：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.
|
12 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2024167
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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