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

Study Overview

• Status: Completed
• Conditions: Risk Reduction
• Intervention / Treatment: Behavioral: Intensive training group

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
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hallym University Sacred Hospital Puyngchon
  • Incheon, Korea, Republic of
    • Gachon University Gil Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Eulji Medical Center
  • Seoul, Korea, Republic of
    • Hallym University Sacred Hospital Gangdong
  • Gyeonggi-do
    • Gunpo, Gyeonggi-do, Korea, Republic of
      • Wonkwang University, Sanbon Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Exit site infection	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
time to the first peritonitis	24 months
Number of ESIs per patient-month	24 months
Days of hospitalization per year	24 months
Systolic pressure and diastolic pressure measured at every visit	24 months
Average number of antihypertensive medications	24 months
Kt/V	24 months
Residual renal function	24 months
Fluid balance score	24 months
Patient survival rate	24 months
Total medical cost	24 months
Total hours of education and training	24 months
Unplanned home visit and education by peritoneal dialysis nurse	24 months
Compliance score of patients	24 months
HbA1c only for patients with diabetes	24 months
Intact PTH level	24 months
Hemoglobin level	24 months
nPNA	24 months
QOL	24 months
SGA	24 months
K level	24 months
Total number of hospitalizations by cause over the last 1 and/or 2 years after the dialysis	24 months
Technical survival rate	24 months
peritonitis rate	24 months

Collaborators and Investigators

• Sponsor: Kook-Hwan Oh
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Kook-Hwan Oh, M.D., PhD, Seoul National University

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 16, 2010
• First Submitted That Met QC Criteria: September 16, 2010
• First Posted (Estimate): September 17, 2010

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 12, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: peritoneal dialysis
• Other Study ID Numbers: TEACH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO