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

Not Applicable

• Conditions: Chronic Kidney Disease
• Interventions: Other: Structured education program

• Registration Number: NCT01630824
• Lead Sponsor: University of Jena

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-28
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-21
• Last Update Posted: 2013-05-22
• Primary Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education	Structured education program	Kidney transplant recipients, who undergo the structured education program

Primary Outcome Measures

Name	Time	Method
transplant survival	2 years

Secondary Outcome Measures

Name	Time	Method
number of rejections	2 years
days at hospital	2 years
blood pressure control	2 years
quality of life (QoL)	2 years
number of infectious complications	2 years

Trial Locations

Locations (1)

Department of Nephrology, University of Jena; 🇩🇪 Jena, Thuringia, Germany