Trial record 2 of 35 for:    Open Studies | "Peritonitis"

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

This study is currently recruiting participants. (see Contacts and Locations)
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: October 28, 2014
Last verified: February 2014
  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:


Further study details as provided by Peking University First Hospital:

Primary Outcome Measures:
  • first-episode peritonitis [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • exit-site infection [ Time Frame: 48 moths ] [ Designated as safety issue: Yes ]
  • technique survival [ Time Frame: 48 moths ] [ Designated as safety issue: Yes ]
  • total survival [ Time Frame: 48 moths ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: January 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: November 2016 (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 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


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:

  • 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;
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 28, 2014
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Peritonitis
Digestive System Diseases
Infection
Intraabdominal Infections
Peritoneal Diseases

ClinicalTrials.gov processed this record on October 29, 2014