Development and Effects of a Structural Education Program in Adult Kidney Transplant Recipients

University of Jena

Status: Unknown

Conditions: Chronic Kidney Disease

Treatments: Other: Structured education program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01630824

NTXEdu2012

Details and patient eligibility

About

Kidney transplantation is the treatment of choice for patients with end-stage renal disease. The purpose of this randomized and controlled study is to evaluate the efficacy of a structured education program for adult kidney transplant recipients. Patients are randomly assigned to an educational program or to a standard care control group. The education group receives 8 lessons (each 90 minutes, 1 lesson per day), starting 4 days after kidney transplantation. Kidney transplant survival, number of rejections, infectious complications, length of hospital stay, blood pressure, HbA1c, glomerular filtration rate, quality of life (QoL) and knowledge are measured in both groups after 6, 12 and 24 months. The investigators postulate that the education group will have superior outcomes compared to the control group.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• being over 18 years recently had a kidney transplantation able to speak, write and understand german willing to participate regular visits after kidney transplantation

Exclusion criteria

• severe complications after recent kidney transplantation early loss of the kidney allograft severe allograft dysfunction

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 2 patient groups

Education

Other group

Description:

Kidney transplant recipients, who undergo the structured education program

Treatment:

Other: Structured education program

Control

No Intervention group

Description:

Kidney transplant recipients without structured education programm