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NCT01630824 Clinical Trial

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

Chronic Kidney Disease Clinical Trial

Official title:
Development an Effects of a Structural Education Programm in Adult Kidney Transplant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01630824
Other study ID # NTXEdu2012
Secondary ID
Status Recruiting
Phase N/A
First received June 26, 2012
Last updated May 21, 2013
Start date June 2012

Study information
Verified date May 2013
Source University of Jena
Contact Claudia Schinkoethe
Phone 004936419324623
Email claudia.schinkoethe@med.uni-jena.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Other:
• Structured education program
structured education program after kidney transplantation

Locations
Country Name City State
Germany Department of Nephrology, University of Jena Jena Thuringia

Sponsors (2)
Lead Sponsor Collaborator
University of Jena Novartis

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary transplant survival 2 years No
Secondary number of rejections 2 years No
Secondary days at hospital 2 years No
Secondary blood pressure control 2 years No
Secondary number of infectious complications 2 years No
Secondary quality of life (QoL) 2 years No
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