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

NCT01204619 | Completed

• 1 other identifier: TEACH
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Risk Reduction

Keywords

peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

• Exit site infection

  24 months

Secondary Outcomes (23)

• 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

Study Arms (2)

Conventional training group

NO INTERVENTION

in-center conventional training programs + two home visits

Intensive training group

EXPERIMENTAL

in-center conventional training programs + an extra structured patient home visits repeatedly and regularly

Behavioral: Intensive training group

Interventions

Intensive training group BEHAVIORAL

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

Intensive training group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Incident patients who have PD catheter insertion for starting PD with Baxter solutions
• \> 20 yr of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Kook-Hwan Oh: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (6)

Wonkwang University, Sanbon Medical Center

Gunpo, Gyeonggi-do, South Korea

Location

Hallym University Sacred Hospital Puyngchon

Anyang, South Korea

Location

Gachon University Gil Hospital

Incheon, South Korea

Location

Eulji Medical Center

Seoul, South Korea

Location

Hallym University Sacred Hospital Gangdong

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kook-Hwan Oh, M.D., PhD

  Seoul National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 17, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 14, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6)