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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01630824
Recruitment Status : Unknown
Verified May 2013 by Claudia Schinkoethe, University of Jena.
Recruitment status was:  Recruiting
First Posted : June 28, 2012
Last Update Posted : May 22, 2013
Information provided by (Responsible Party):
Claudia Schinkoethe, 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: Structured education program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Development an Effects of a Structural Education Programm in Adult Kidney Transplant Recipients
Study Start Date : June 2012
Estimated Primary Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Kidney transplant recipients, who undergo the structured education program
Other: Structured education program
structured education program after kidney transplantation

No Intervention: Control
Kidney transplant recipients without structured education programm

Primary Outcome Measures :
  1. transplant survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. number of rejections [ Time Frame: 2 years ]
  2. days at hospital [ Time Frame: 2 years ]
  3. blood pressure control [ Time Frame: 2 years ]
  4. number of infectious complications [ Time Frame: 2 years ]
  5. quality of life (QoL) [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01630824

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Contact: Claudia Schinkoethe 004936419324623

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Department of Nephrology, University of Jena Recruiting
Jena, Thuringia, Germany, 07749
Contact: Claudia Schinkoethe    004936419324623   
Sponsors and Collaborators
University of Jena
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Principal Investigator: Gunter Wolf University of Jena
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Responsible Party: Claudia Schinkoethe, Dr. med. Claudia Schinkoethe, University of Jena Identifier: NCT01630824    
Other Study ID Numbers: NTXEdu2012
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013
Keywords provided by Claudia Schinkoethe, University of Jena:
education program
kidney transplantation
renal transplantation
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency