- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Hunan
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Changsha, Hunan, Porcelana, 410013
- Third Xiangya Hospital of Central South University
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Unplanned Readmission Rate
Periodo de tiempo: 12 months
|
The proportion of participants who experience unplanned hospital readmission during the 12-month follow-up period.
|
12 months
|
|
Peritonitis Incidence
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedad crónica
- Atributos de la enfermedad
- Insuficiencia renal
- Condiciones Patológicas, Signos y Síntomas
- Insuficiencia Renal Crónica
Otros números de identificación del estudio
- 2024167
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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