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

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

Study Overview

• Status: Completed
• Conditions: Peritonitis
• Intervention / Treatment: Behavioral: operation inspection

Detailed Description

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
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Jie Dong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: operation inspection; 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.	Behavioral: operation inspection; 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	Behavioral: operation inspection; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Investigators: Principal Investigator: Jie Dong, MD,PhD,, Peking University First Hospital

Publications and helpful links

General Publications

• Xu Y, Zhang Y, Yang B, Luo S, Yang Z, Johnson DW, Dong J. Prevention of peritoneal dialysis-related peritonitis by regular patient retraining via technique inspection or oral education: a randomized controlled trial. Nephrol Dial Transplant. 2020 Apr 1;35(4):676-686. doi: 10.1093/ndt/gfz238.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: June 14, 2012
• First Submitted That Met QC Criteria: June 14, 2012
• First Posted (Estimate): June 18, 2012

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: peritoneal dialysis; peritonitis; retraining
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Intraabdominal Infections; Peritonitis
• Other Study ID Numbers: PD TRAINING