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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
  Purpose

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


Condition Intervention
Peritonitis
 Behavioral: operation inspection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by Peking University First Hospital:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
No Intervention: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01621997

Contacts
Contact: Jie Dong, MD, PhD 851083572388 dongjie@medmail.com.cn

Locations
China, Beijing
Jie Dong Recruiting
Beijing, Beijing, China, 100034
Contact: Jie Dong, MD, PhD     861083572388     dongjie@medmail.com.cn    
Sponsors and Collaborators
Peking University First Hospital
Investigators
Principal Investigator: Jie Dong, MD,PhD, Peking University First Hospital
  More Information

No publications provided

Responsible Party: Dong Jie, Institute of Nephrology, Division of Renal, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT01621997     History of Changes
Other Study ID Numbers: PD TRAINING
Study First Received: June 14, 2012
Last Updated: June 14, 2012
Health Authority: China: Ethics Committee

Keywords provided by Peking University First Hospital:
peritoneal dialysis
retraining
peritonitis

Additional relevant MeSH terms:
Peritonitis
Peritoneal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013