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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01204619
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : April 14, 2016
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Kook-Hwan Oh, Seoul National University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Risk Reduction Behavioral: Intensive training group Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial on Education And Clinical Outcomes for Home PD Patients (TEACH)
Study Start Date : December 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : March 2016

Arm Intervention/treatment
No Intervention: Conventional training group
in-center conventional training programs + two home visits
Experimental: Intensive training group
in-center conventional training programs + an extra structured patient home visits repeatedly and regularly
Behavioral: Intensive training group
an extra structured patient centric training program on PD technique and diet according to the developed training curriculum

Primary Outcome Measures :
  1. Exit site infection [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. time to the first peritonitis [ Time Frame: 24 months ]
  2. Number of ESIs per patient-month [ Time Frame: 24 months ]
  3. Days of hospitalization per year [ Time Frame: 24 months ]
  4. Systolic pressure and diastolic pressure measured at every visit [ Time Frame: 24 months ]
  5. Average number of antihypertensive medications [ Time Frame: 24 months ]
  6. Kt/V [ Time Frame: 24 months ]
  7. Residual renal function [ Time Frame: 24 months ]
  8. Fluid balance score [ Time Frame: 24 months ]
  9. Patient survival rate [ Time Frame: 24 months ]
  10. Total medical cost [ Time Frame: 24 months ]
  11. Total hours of education and training [ Time Frame: 24 months ]
  12. Unplanned home visit and education by peritoneal dialysis nurse [ Time Frame: 24 months ]
  13. Compliance score of patients [ Time Frame: 24 months ]
  14. HbA1c only for patients with diabetes [ Time Frame: 24 months ]
  15. Intact PTH level [ Time Frame: 24 months ]
  16. Hemoglobin level [ Time Frame: 24 months ]
  17. nPNA [ Time Frame: 24 months ]
  18. QOL [ Time Frame: 24 months ]
  19. SGA [ Time Frame: 24 months ]
  20. K level [ Time Frame: 24 months ]
  21. Total number of hospitalizations by cause over the last 1 and/or 2 years after the dialysis [ Time Frame: 24 months ]
  22. Technical survival rate [ Time Frame: 24 months ]
  23. peritonitis rate [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Incident patients who have PD catheter insertion for starting PD with Baxter solutions
  • > 20 yr of age

Exclusion Criteria:

  • Patients who have undergone dialysis or received kidney transplant (note, however, that patients who are currently undergoing emergency hemodialysis temporarily right before the PD do not fall under the exclusion criteria.)
  • Patients who are likely to receive kidney transplant or shift to hemodialysis within the following 1 year
  • Patients diagnosed with acute inflammatory disease for the past three months
  • Patients currently diagnosed with chronic inflammatory disease
  • Currently pregnant or breastfeeding
  • Patients who are involved in other clinical trial within 30 days prior to enrollment
  • Patients who are currently hospitalized in care facilities such as nursing home, etc., or those who are expected to be hospitalized for the duration of the clinical test
  • Patients who cannot perform PD by themselves
  • Patients considered by the person in charge of the clinical test to have difficulty in participating in this clinical test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01204619

Korea, Republic of
Wonkwang University, Sanbon Medical Center
Gunpo, Gyeonggi-do, Korea, Republic of
Hallym University Sacred Hospital Puyngchon
Anyang, Korea, Republic of
Gachon University Gil Hospital
Incheon, Korea, Republic of
Eulji Medical Center
Seoul, Korea, Republic of
Hallym University Sacred Hospital Gangdong
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Kook-Hwan Oh
Baxter Healthcare Corporation
Principal Investigator: Kook-Hwan Oh, M.D., PhD Seoul National University

Responsible Party: Kook-Hwan Oh, Associate Professor, Seoul National University Hospital Identifier: NCT01204619     History of Changes
Other Study ID Numbers: TEACH
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kook-Hwan Oh, Seoul National University Hospital:
peritoneal dialysis