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

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ClinicalTrials.gov Identifier: NCT01621997
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Dong Jie, Peking University First Hospital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : December 2010
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: operation inspection 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 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 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





Primary Outcome Measures :
  1. first-episode peritonitis [ Time Frame: 48 months ]

Secondary Outcome Measures :
  1. exit-site infection [ Time Frame: 48 moths ]
  2. technique survival [ Time Frame: 48 moths ]
  3. total survival [ Time Frame: 48 moths ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621997


Locations
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China, Beijing
Jie Dong
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital
Investigators
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Principal Investigator: Jie Dong, MD,PhD, Peking University First Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: June 18, 2012    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Keywords provided by Dong Jie, Peking University First Hospital:
peritoneal dialysis
retraining
peritonitis
Additional relevant MeSH terms:
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Peritonitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases