Skip to main content
OpenTrials
Completed

NCT Number: NCT01204619

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Risk Reduction Behavior Risk Reduction Behavior

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wonkwang University, Sanbon Medical Center, Gunpo, Gyeonggi-do, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive training group

Behavioral

an extra structured patient centric training program on PD technique and diet according to the developed training curriculum

Primary outcomes

  1. Exit site infection

    Time frame: 24 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kook-Hwan Oh

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Acronym: TEACH

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Sep 17, 2010
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.