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

Sponsor

Peking University First Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01621997

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Peritonitis	Behavioral: operation inspection	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

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

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

Experimental: usual care

Patients in the usual care group did not receive any retraining

Behavioral: operation inspection

Outcome Measures

Primary Outcome Measures

first-episode peritonitis [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.

Secondary Outcome Measures

first-episode enteric peritonitis,first-episode non-enteric peritonitis [48 moths]
Enteric organisms included enterococcus and enterobacter.
transition transition to haemodialysis, and all-cause death. [48 moths]
transition to haemodialysis, and all-cause death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jie Dong	Beijing	Beijing	China	100034

Sponsors and Collaborators

Peking University First Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dong Jie, Institute of Nephrology, Division of Renal, Peking University First Hospital

ClinicalTrials.gov Identifier:

NCT01621997

Other Study ID Numbers:

PD TRAINING

First Posted:

Jun 18, 2012

Last Update Posted:

Aug 28, 2020

Last Verified:

Jul 1, 2019

Keywords provided by Dong Jie, Institute of Nephrology, Division of Renal, Peking University First Hospital

peritoneal dialysis

retraining

peritonitis

Additional relevant MeSH terms:

Peritonitis

Study Results

No Results Posted as of Aug 28, 2020