Clinical trial NCT01204619: Trial on Education And Clinical Outcomes for Home PD Patients (TEACH)
Official title: Trial on Education And Clinical Outcomes for Home PD Patients (TEACH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Reduction
Keywords: peritoneal dialysis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2010-09-17
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exit site infection
timeFrame: 24 months
Secondary outcomes:
measure: time to the first peritonitis
timeFrame: 24 months
measure: Number of ESIs per patient-month
timeFrame: 24 months
measure: Days of hospitalization per year
timeFrame: 24 months
measure: Systolic pressure and diastolic pressure measured at every visit
timeFrame: 24 months
measure: Average number of antihypertensive medications
timeFrame: 24 months
measure: Kt/V
timeFrame: 24 months
measure: Residual renal function
timeFrame: 24 months
measure: Fluid balance score
timeFrame: 24 months
measure: Patient survival rate
timeFrame: 24 months
measure: Total medical cost
timeFrame: 24 months
measure: Total hours of education and training
timeFrame: 24 months
measure: Unplanned home visit and education by peritoneal dialysis nurse
timeFrame: 24 months
measure: Compliance score of patients
timeFrame: 24 months
measure: HbA1c only for patients with diabetes
timeFrame: 24 months
measure: Intact PTH level
timeFrame: 24 months
measure: Hemoglobin level
timeFrame: 24 months
measure: nPNA
timeFrame: 24 months
measure: QOL
timeFrame: 24 months
measure: SGA
timeFrame: 24 months
measure: K level
timeFrame: 24 months
measure: Total number of hospitalizations by cause over the last 1 and/or 2 years after the dialysis
timeFrame: 24 months
measure: Technical survival rate
timeFrame: 24 months
measure: peritonitis rate
timeFrame: 24 months
Other outcomes:
Locations:
city: Gunpo
country: Korea, Republic of
facility: Wonkwang University, Sanbon Medical Center
state: Gyeonggi-do
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Hospital Puyngchon
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seoul
country: Korea, Republic of
facility: Eulji Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University Sacred Hospital Gangdong
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University
name: Kook-Hwan Oh, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: