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

Primary Purpose

Peritonitis

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

operation inspection

About this trial

This is an interventional prevention trial for Peritonitis focused on measuring peritoneal dialysis, retraining, peritonitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Jie Dong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

operation inspection

verbal education

usual care

Arm Description

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.

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.

Patients in the usual care group did not receive any retraining

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Enteric organisms included enterococcus and enterobacter.

transition transition to haemodialysis, and all-cause death.

transition to haemodialysis, and all-cause death.

Full Information

NCT ID

NCT01621997

First Posted

June 14, 2012

Last Updated

August 26, 2020

Sponsor

Peking University First Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01621997

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

June 2018 (Actual)

Study Completion Date

June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University First Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peritonitis

Keywords

peritoneal dialysis, retraining, peritonitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

operation inspection

Arm Type

Experimental

Arm Description

Arm Title

verbal education

Arm Type

Experimental

Arm Description

Arm Title

usual care

Arm Type

Experimental

Arm Description

Patients in the usual care group did not receive any retraining

Intervention Type

Behavioral

Intervention Name(s)

operation inspection

Intervention Description

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

Primary Outcome Measure Information:

Title

first-episode peritonitis

Description

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 Outcome Measure Information:

Title

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

Description

Enteric organisms included enterococcus and enterobacter.

Time Frame

48 moths

Title

transition transition to haemodialysis, and all-cause death.

Description

transition to haemodialysis, and all-cause death.

Time Frame

48 moths

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jie Dong, MD,PhD,

Organizational Affiliation

Peking University First Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jie Dong

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100034

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

31821491

Citation

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.

Results Reference

derived

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

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