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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Claudia Schinkoethe, University of Jena

Study Description
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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

Study Design
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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


Arms and Interventions
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Arm Intervention/treatment
Education
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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01630824


Contacts
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Contact: Claudia Schinkoethe 004936419324623 claudia.schinkoethe@med.uni-jena.de

Locations
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Germany
Department of Nephrology, University of Jena Recruiting
Jena, Thuringia, Germany, 07749
Contact: Claudia Schinkoethe    004936419324623    claudia.schinkoethe@med.uni-jena.de   
Sponsors and Collaborators
University of Jena
Novartis
Investigators
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Principal Investigator: Gunter Wolf University of Jena
More Information
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Responsible Party: Claudia Schinkoethe, Dr. med. Claudia Schinkoethe, University of Jena
ClinicalTrials.gov 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
evaluation
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency