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

This study has been completed.
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: April 12, 2016
Last verified: April 2016
September 16, 2010
April 12, 2016
December 2010
July 2015   (Final data collection date for primary outcome measure)
Exit site infection [ Time Frame: 24 months ]
number of hospitalization per year [ Time Frame: 24 months ]
Complete list of historical versions of study NCT01204619 on ClinicalTrials.gov Archive Site
  • time to the first peritonitis [ Time Frame: 24 months ]
  • Number of ESIs per patient-month [ Time Frame: 24 months ]
  • Days of hospitalization per year [ Time Frame: 24 months ]
  • Systolic pressure and diastolic pressure measured at every visit [ Time Frame: 24 months ]
  • Average number of antihypertensive medications [ Time Frame: 24 months ]
  • Kt/V [ Time Frame: 24 months ]
  • Residual renal function [ Time Frame: 24 months ]
  • Fluid balance score [ Time Frame: 24 months ]
  • Patient survival rate [ Time Frame: 24 months ]
  • Total medical cost [ Time Frame: 24 months ]
  • Total hours of education and training [ Time Frame: 24 months ]
  • Unplanned home visit and education by peritoneal dialysis nurse [ Time Frame: 24 months ]
  • Compliance score of patients [ Time Frame: 24 months ]
  • HbA1c only for patients with diabetes [ Time Frame: 24 months ]
  • Intact PTH level [ Time Frame: 24 months ]
  • Hemoglobin level [ Time Frame: 24 months ]
  • nPNA [ Time Frame: 24 months ]
  • QOL [ Time Frame: 24 months ]
  • SGA [ Time Frame: 24 months ]
  • K level [ Time Frame: 24 months ]
  • Total number of hospitalizations by cause over the last 1 and/or 2 years after the dialysis [ Time Frame: 24 months ]
  • Technical survival rate [ Time Frame: 24 months ]
  • peritonitis rate [ Time Frame: 24 months ]
  • Time to the first peritonitis episode [ Time Frame: 24 months ]
  • Time to the first ESI episode [ Time Frame: 24 months ]
  • Number of ESIs per patient-month [ Time Frame: 24 months ]
  • Days of hospitalization per year [ Time Frame: 24 months ]
  • Systolic pressure and diastolic pressure measured at every visit [ Time Frame: 24 months ]
  • Average number of antihypertensive medications [ Time Frame: 24 months ]
  • Kt/V [ Time Frame: 24 months ]
  • Residual renal function [ Time Frame: 24 months ]
  • Fluid balance score [ Time Frame: 24 months ]
  • Patient survival rate [ Time Frame: 24 months ]
  • Total medical cost [ Time Frame: 24 months ]
  • Total hours of education and training [ Time Frame: 24 months ]
  • Unplanned home visit and education by peritoneal dialysis nurse [ Time Frame: 24 months ]
  • Compliance score of patients [ Time Frame: 24 months ]
  • HbA1c only for patients with diabetes [ Time Frame: 24 months ]
  • Intact PTH level [ Time Frame: 24 months ]
  • Hemoglobin level [ Time Frame: 24 months ]
  • nPNA [ Time Frame: 24 months ]
  • QOL [ Time Frame: 24 months ]
  • SGA [ Time Frame: 24 months ]
  • K level [ Time Frame: 24 months ]
  • Total number of hospitalizations by cause over the last 1 and/or 2 years after the dialysis [ Time Frame: 24 months ]
  • Technical survival rate [ Time Frame: 24 months ]
  • peritonitis rate [ Time Frame: 24 months ]
Not Provided
Not Provided
 
Trial on Education And Clinical Outcomes for Home PD Patients (TEACH)
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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Risk Reduction
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 + two home visits
  • Experimental: Intensive training group
    in-center conventional training programs + an extra structured patient home visits repeatedly and regularly
    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.
 
Completed
104
March 2016
July 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01204619
TEACH
No
Not Provided
Plan to Share IPD: 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
April 2016

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