NCT01204619

Trial on Education And Clinical Outcomes for Home PD Patients (TEACH)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Kook-Hwan Oh · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Since the emergence of home peritoneal dialysis as an alternative to in-center hemodialysis for chronic renal replacement therapy in the late 1970s, the percentage of dialysis patients on PD has continued to decrease each year. There have been a growing concern and research on patient and technique survival of peritoneal dialysis versus hemodialysis to find influential factors for better clinical outcomes. Meanwhile, technique failure rates were significantly higher in small centers treating less than twenty five PD patients. And there was a result for better technique survival after the second year, among the patients trained at the BREC(Baxter Renal Education Center). Better technique survival in large centers can be assumed with not only their more experience with patient management but also their educational infrastructure compared to small-sized centers. Throughout our experiences in the last 30 years, we have recognized that a major element of PD program is patient training, however few data are available in terms of the relationship between PD training and treatment outcome and mostly are retrospective and non-randomized. Moreover, the technique survival and patient survival were analyzed with no significant difference. From the insight, we decided to study prospectively to evaluate the efficacy of well-structured education program in terms of various patient outcomes in incident patients on PD.

Detailed description

This study will be conducted as multi-center, open-label, randomized, controlled trial. One hundred four patient starting PD will be randomized into two training groups. Patients in the conventional training group (CG) will be given non-standardized in-center conventional training programs plus two sessions of training by home visit, while those in intensive training group (IG) given in-center conventional training programs plus repeated home visits regularly over 24-month period (total thirteen visits). The primary end point of the study is exit site infection (ESI). Secondary endpoints are peritonitis and all-cause infection. Generalized Estimating Equations will be used to assess the adjusted effect of training level on the ESI and Cox regression model employed to evaluate the effect on the peritonitis and other secondary outcomes.

Conditions

• Risk Reduction

Interventions

Type	Name	Description
BEHAVIORAL	Intensive training group	an extra structured patient centric training program on PD technique and diet according to the developed training curriculum

Timeline

• Start date: 2010-12-01
• Primary completion: 2015-07-01
• Completion: 2016-03-01
• First posted: 2010-09-17
• Last updated: 2016-04-14

Locations

6 sites across 1 country: South Korea