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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

September 16, 2010
June 6, 2012
December 2010
July 2014   (final data collection date for primary outcome measure)
number of hospitalization per year [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01204619 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Trial on Education And Clinical Outcomes for Home PD Patients (TEACH)
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Education
Behavioral: Intensive training group
an extra structured patient centric training program on PD technique and diet according to the developed training curriculum
  • 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
    Intervention: Behavioral: Intensive training group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
December 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Kook-Hwan Oh, M.D., PhD 82-2-2072-0776 khoh@snu.ac.kr
Korea, Republic of
 
NCT01204619
TEACH
No
Kook-Hwan Oh, Seoul National University Hospital
Kook-Hwan Oh
Baxter Healthcare Corporation
Principal Investigator: Kook-Hwan Oh, M.D., PhD Seoul National University
Seoul National University Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP