Different Retraining Methods vs Usual Care on the Prevention of Peritonitis in Peritoneal Dialysis

N/ACompletedNCT01621997

Peking University First Hospital150 enrolled

Overview

To examine whether retraining via operation inspection or verbal education can reduce the risk for peritonitis in PD patients.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

150

Conditions

Peritonitis

Interventions

operation inspectionBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Jie Dong

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

first-episode peritonitis

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.

Time frame: 48 months

Secondary Outcomes

first-episode enteric peritonitis,first-episode non-enteric peritonitis

Enteric organisms included enterococcus and enterobacter.

Time frame: 48 moths

transition transition to haemodialysis, and all-cause death.

transition to haemodialysis, and all-cause death.

Time frame: 48 moths

Data from ClinicalTrials.gov

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