Different Retraining Methods vs Usual Care on the Prevention of Peritonitis in Peritoneal Dialysis
Retraining Via Operation Inspection or Verbal Education vs Usual Care on the Prevention of Peritonitis in Peritoneal Dialysis
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The design is prospective, randomized, controlled study. At baseline (during the first month), they will receive a standard training program on performing bag exchange and education on the prevention of peritonitis.
Then the participants will be randomized into three groups: retraining via operation inspection (G1), retraining via verbal education (G2) and usual care (G3). Retraining will be performed every 2 months in G1 and G2 group.
During the following 2 years or a longer period, all the participants will be followed up frequently with outcome events recorded.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100034
- Jie Dong
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- CAPD patients.
- Medically stable and receiving PD for<1 week
- age between 18 and 80 years
- self-care or doing bag exchange by a fixed assistant Exclusion Criteria
- followed up at least every 2 months
- dialyzed with glucose lactate-buffered PD solutions produced by Baxter Corp, China
Exclusion Criteria:
- Pregnancy;
- undergoing APD therapy
- Intolerance to the study protocols;
- Severe and unstable condition, acute or chronic inflammation disease;
- a high probability (assessed by the recruiting physician) of receiving a kidney transplant or transferring to HD or drop-out due to socioeconomic causes within 6 months;
- suffering peritonitis before receiving the interventions
- cognitive or psychological dysfunction;
- communication barrier
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: operation inspection
During retraining the patients performed bag exchange under the supervision of a nurse.
The nurse ensured that each error listed in the NAC form should be avoided, thus immediately corrected any wrong steps if only.
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Retraining via operation inspection means that nurses check if patients can follow the taught skill during the procedure of bag exchange and correct wrong steps in one-to-one way every 2 months. Retraining via verbal education means that nurses remind patients of key points of bag exchange through interactive quiz derived from above checklist every 2 months till 24 months |
|
Experimental: verbal education
Patients in the oral education group also underwent retraining every 2 months.
A nurse would address all items in the NAC form one by one, to remind the patient of the key points of bag exchange.
Scores calculated by the sum of error items during the bag exchange for patients in technique inspection group, or by the sum of "yes" in the interactive quiz for patients in verbal education group.
|
Retraining via operation inspection means that nurses check if patients can follow the taught skill during the procedure of bag exchange and correct wrong steps in one-to-one way every 2 months. Retraining via verbal education means that nurses remind patients of key points of bag exchange through interactive quiz derived from above checklist every 2 months till 24 months |
|
Experimental: usual care
Patients in the usual care group did not receive any retraining
|
Retraining via operation inspection means that nurses check if patients can follow the taught skill during the procedure of bag exchange and correct wrong steps in one-to-one way every 2 months. Retraining via verbal education means that nurses remind patients of key points of bag exchange through interactive quiz derived from above checklist every 2 months till 24 months |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
first-episode peritonitis
Periodo de tiempo: 48 months
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Infection rates were calculated as the number of infections divided by the total time at risk, and expressed as episodes per 100 patient-years at risk.
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48 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
first-episode enteric peritonitis,first-episode non-enteric peritonitis
Periodo de tiempo: 48 moths
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Enteric organisms included enterococcus and enterobacter.
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48 moths
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transition transition to haemodialysis, and all-cause death.
Periodo de tiempo: 48 moths
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transition to haemodialysis, and all-cause death.
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48 moths
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jie Dong, MD,PhD,, Peking University First Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
Otros números de identificación del estudio
- PD TRAINING
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