Retraining Via Operation Inspection or Verbal Education vs Usual Care on the Prevention of Peritonitis in Peritoneal Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- first-episode peritonitis
研究概览
简要总结
To examine whether retraining via operation inspection or verbal education can reduce the risk for peritonitis in PD patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: operation inspection (Behavioral)
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.
干预措施: operation inspection (Behavioral)
usual care
Patients in the usual care group did not receive any retraining
干预措施: operation inspection (Behavioral)
结局指标
主要结局
first-episode peritonitis
时间窗: 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.
次要结局
- first-episode enteric peritonitis,first-episode non-enteric peritonitis(48 moths)
- transition transition to haemodialysis, and all-cause death.(48 moths)
研究者
Dong Jie
Institute of Nephrology, Division of Renal
Peking University First Hospital