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

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

Detailed Description
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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.

Official Title
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Retraining Via Operation Inspection or Verbal Education vs Usual Care on the Prevention of Peritonitis in Peritoneal Dialysis

Conditions
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Peritonitis

Intervention / Treatment
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* Behavioral: operation inspection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: operation inspection<br>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. | Behavioral: operation inspection<br>* 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<br>|
| Experimental: verbal education<br>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. | Behavioral: operation inspection<br>* 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<br>|
| Experimental: usual care<br>Patients in the usual care group did not receive any retraining | Behavioral: operation inspection<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first-episode enteric peritonitis,first-episode non-enteric peritonitis | Enteric organisms included enterococcus and enterobacter. | 48 moths | 
| transition transition to haemodialysis, and all-cause death. | transition to haemodialysis, and all-cause death. | 48 moths | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peritoneal dialysis, retraining, peritonitis