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

NCT ID: NCT01621997

Last Updated: 2020-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2018-06-30

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.

Conditions

Peritonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

operation inspection

During retraining the patients performed bag exchange under the supervision of a nurse. The nurse ensured that each error listed in the NAC form should be avoided, thus immediately corrected any wrong steps if only.

Group Type: EXPERIMENTAL

operation inspection

Intervention Type: BEHAVIORAL

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

verbal education

Patients in the oral education group also underwent retraining every 2 months. A nurse would address all items in the NAC form one by one, to remind the patient of the key points of bag exchange. Scores calculated by the sum of error items during the bag exchange for patients in technique inspection group, or by the sum of "yes" in the interactive quiz for patients in verbal education group.

Group Type: EXPERIMENTAL

operation inspection

Intervention Type: BEHAVIORAL

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

usual care

Patients in the usual care group did not receive any retraining

Group Type: EXPERIMENTAL

operation inspection

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• CAPD patients.
• Medically stable and receiving PD for<1 week
• age between 18 and 80 years

Exclusion Criteria

• followed up at least every 2 months
• dialyzed with glucose lactate-buffered PD solutions produced by Baxter Corp, China

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dong Jie

Institute of Nephrology, Division of Renal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jie Dong, MD,PhD,

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Jie Dong

Beijing, Beijing Municipality, China

Countries

China

References

Xu Y, Zhang Y, Yang B, Luo S, Yang Z, Johnson DW, Dong J. Prevention of peritoneal dialysis-related peritonitis by regular patient retraining via technique inspection or oral education: a randomized controlled trial. Nephrol Dial Transplant. 2020 Apr 1;35(4):676-686. doi: 10.1093/ndt/gfz238.

Reference Type: DERIVED

PMID: 31821491 (View on PubMed)

Other Identifiers

PD TRAINING

Identifier Type: -

Identifier Source: org_study_id