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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Beijing
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Beijing, Beijing, Chine, 100034
- Jie Dong
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Expérimental: 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 |
|
Expérimental: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
first-episode peritonitis
Délai: 48 months
|
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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
first-episode enteric peritonitis,first-episode non-enteric peritonitis
Délai: 48 moths
|
Enteric organisms included enterococcus and enterobacter.
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48 moths
|
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transition transition to haemodialysis, and all-cause death.
Délai: 48 moths
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transition to haemodialysis, and all-cause death.
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48 moths
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jie Dong, MD,PhD,, Peking University First Hospital
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PD TRAINING
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