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

Risk Reduction Clinical Trial

— TEACH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204619
• Other study ID #: TEACH
• Status: Completed
• Phase: N/A
• First received: September 16, 2010
• Last updated: April 12, 2016
• Start date: December 2010
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Risk Reduction

Intervention

Behavioral:
• Intensive training group
an extra structured patient centric training program on PD technique and diet according to the developed training curriculum

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Kook-Hwan Oh	Baxter Healthcare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exit site infection		24 months	No
Secondary	time to the first peritonitis		24 months	No
Secondary	Number of ESIs per patient-month		24 months	No
Secondary	Days of hospitalization per year		24 months	No
Secondary	Systolic pressure and diastolic pressure measured at every visit		24 months	No
Secondary	Average number of antihypertensive medications		24 months	No
Secondary	Kt/V		24 months	No
Secondary	Residual renal function		24 months	No
Secondary	Fluid balance score		24 months	No
Secondary	Patient survival rate		24 months	No
Secondary	Total medical cost		24 months	No
Secondary	Total hours of education and training		24 months	No
Secondary	Unplanned home visit and education by peritoneal dialysis nurse		24 months	No
Secondary	Compliance score of patients		24 months	No
Secondary	HbA1c only for patients with diabetes		24 months	No
Secondary	Intact PTH level		24 months	No
Secondary	Hemoglobin level		24 months	No
Secondary	nPNA		24 months	No
Secondary	QOL		24 months	No
Secondary	SGA		24 months	No
Secondary	K level		24 months	No
Secondary	Total number of hospitalizations by cause over the last 1 and/or 2 years after the dialysis		24 months	No
Secondary	Technical survival rate		24 months	No
Secondary	peritonitis rate		24 months	No