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

This study is currently recruiting participants.
Verified February 2014 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: February 20, 2014
Last verified: February 2014

June 14, 2012
February 20, 2014
January 2012
December 2015   (final data collection date for primary outcome measure)
first-episode peritonitis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01621997 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Peritonitis
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.

  • Experimental: operation inspection
    Intervention: Behavioral: operation inspection
  • Experimental: verbal education
    Intervention: Behavioral: operation inspection
  • Experimental: usual care
    Intervention: Behavioral: operation inspection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
July 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Jie Dong, MD, PhD 851083572388 dongjie@medmail.com.cn
China
 
NCT01621997
PD TRAINING
No
Dong Jie, Peking University First Hospital
Peking University First Hospital
Not Provided
Principal Investigator: Jie Dong, MD,PhD, Peking University First Hospital
Peking University First Hospital
February 2014

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