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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Seoul National University Hospital
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Kook-Hwan Oh, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01204619
First received: September 16, 2010
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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 Intervention
Education
Behavioral: Intensive training group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • number of hospitalization per year [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to the first peritonitis episode [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Time to the first ESI episode [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of ESIs per patient-month [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Days of hospitalization per year [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Systolic pressure and diastolic pressure measured at every visit [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Average number of antihypertensive medications [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Kt/V [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Residual renal function [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Fluid balance score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Patient survival rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Total medical cost [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Total hours of education and training [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Unplanned home visit and education by peritoneal dialysis nurse [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Compliance score of patients [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • HbA1c only for patients with diabetes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Intact PTH level [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Hemoglobin level [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • nPNA [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • QOL [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • SGA [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • K level [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Total number of hospitalizations by cause over the last 1 and/or 2 years after the dialysis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Technical survival rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • peritonitis rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional training group
in-center conventional training programs
Experimental: Intensive training group
in-center conventional training programs + an extra structured patient centric training program
Behavioral: Intensive training group
an extra structured patient centric training program on PD technique and diet according to the developed training curriculum

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Incident patients 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204619

Contacts
Contact: Kook-Hwan Oh, M.D., PhD 82-2-2072-0776 khoh@snu.ac.kr

Locations
Korea, Republic of
Wonkwang University, Sanbon Medical Center Recruiting
Gunpo, Gyeonggi-do, Korea, Republic of
Contact: Hyun-Wook Kim, MD         
Hallym University Sacred Hospital Puyngchon Recruiting
Anyang, Korea, Republic of
Contact: Seong Gyun Kim         
Gachon University Gil Hospital Recruiting
Incheon, Korea, Republic of
Contact: Jae Hyun Chang, M.D.         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kook-Hawn Oh, MD.,PhD    82-2-2072-0776    khoh@anu.ac.kr   
Principal Investigator: Kook-Hawn Oh         
Hallym University Sacred Hospital Gangdong Recruiting
Seoul, Korea, Republic of
Contact: Ji Eun Oh         
Eulji Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Young-Hwan Hwang         
Sponsors and Collaborators
Kook-Hwan Oh
Baxter Healthcare Corporation
Investigators
Principal Investigator: Kook-Hwan Oh, M.D., PhD Seoul National University
  More Information

No publications provided

Responsible Party: Kook-Hwan Oh, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01204619     History of Changes
Other Study ID Numbers: TEACH
Study First Received: September 16, 2010
Last Updated: June 6, 2012
Health Authority: Korea: Institutional Review Board, Seoul National University Hospital

Keywords provided by Seoul National University Hospital:
peritoneal dialysis

ClinicalTrials.gov processed this record on September 18, 2014