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

This study is currently recruiting participants.

Verified June 2012 by Peking University First Hospital

Sponsor:

Information provided by (Responsible Party):

Dong Jie, Peking University First Hospital

ClinicalTrials.gov Identifier:

NCT01621997

First received: June 14, 2012

Last updated: NA

Last verified: June 2012

History: No changes posted

Tracking Information

First Received Date ^ICMJE

June 14, 2012

Last Updated Date

June 14, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

first-episode peritonitis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

exit-site infection [ Time Frame: 24 moths ] [ Designated as safety issue: Yes ]
technique survival [ Time Frame: 24 moths ] [ Designated as safety issue: Yes ]
total survival [ Time Frame: 24 moths ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Peritonitis

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: operation inspection
Intervention: Behavioral: operation inspection
Experimental: verbal education
Intervention: Behavioral: operation inspection
No Intervention: usual care
Intervention: Behavioral: operation inspection

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

January 2016

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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;
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;
cognitive or psychological dysfunction;
communication barrier

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jie Dong, MD, PhD

851083572388

dongjie@medmail.com.cn

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01621997

Other Study ID Numbers ^ICMJE

PD TRAINING

Has Data Monitoring Committee

Responsible Party

Dong Jie, Peking University First Hospital

Study Sponsor ^ICMJE

Peking University First Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jie Dong, MD,PhD,

Peking University First Hospital

Information Provided By

Peking University First Hospital

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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