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

Peking University

Status: Completed

Conditions: Peritonitis

Treatments: Behavioral: operation inspection

Study type: Interventional

Funder types: Other

Identifiers

NCT01621997

PD TRAINING

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

operation inspection

Experimental group

Description:

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.

Treatment:

Behavioral: operation inspection

verbal education

Experimental group

Description:

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.

Treatment:

Behavioral: operation inspection

usual care

Experimental group

Description:

Patients in the usual care group did not receive any retraining

Treatment:

Behavioral: operation inspection