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
1 other identifier
interventional
150
1 country
1
Brief Summary
To examine whether retraining via operation inspection or verbal education can reduce the risk for peritonitis in PD patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 14, 2012
CompletedFirst Posted
Study publicly available on registry
June 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedAugust 28, 2020
July 1, 2019
7.5 years
June 14, 2012
August 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
first-episode enteric peritonitis,first-episode non-enteric peritonitis
48 moths
transition transition to haemodialysis, and all-cause death.
48 moths
Study Arms (3)
operation inspection
EXPERIMENTALDuring 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.
verbal education
EXPERIMENTALPatients 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.
usual care
EXPERIMENTALPatients in the usual care group did not receive any retraining
Interventions
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 Criteria
You may qualify if:
- CAPD patients.
- Medically stable and receiving PD for\<1 week
- age between 18 and 80 years
You may not qualify if:
- followed up at least every 2 months
- dialyzed with glucose lactate-buffered PD solutions produced by Baxter Corp, China
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jie Dong
Beijing, Beijing Municipality, 100034, China
Related Publications (1)
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.
PMID: 31821491DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Dong, MD,PhD,
Peking University First Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Institute of Nephrology, Division of Renal
Study Record Dates
First Submitted
June 14, 2012
First Posted
June 18, 2012
Study Start
December 1, 2010
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
August 28, 2020
Record last verified: 2019-07