This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Claudia Schinkoethe, University of Jena.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Claudia Schinkoethe, University of Jena Identifier:
First received: June 26, 2012
Last updated: May 21, 2013
Last verified: May 2013
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 Intervention
Chronic Kidney Disease Other: Structured education program

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Claudia Schinkoethe, University of Jena:

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

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

Estimated Enrollment: 180
Study Start Date: June 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01630824

Contact: Claudia Schinkoethe 004936419324623

Department of Nephrology, University of Jena Recruiting
Jena, Thuringia, Germany, 07749
Contact: Claudia Schinkoethe    004936419324623   
Sponsors and Collaborators
University of Jena
Principal Investigator: Gunter Wolf University of Jena
  More Information

Responsible Party: Claudia Schinkoethe, Dr. med. Claudia Schinkoethe, University of Jena Identifier: NCT01630824     History of Changes
Other Study ID Numbers: NTXEdu2012
Study First Received: June 26, 2012
Last Updated: May 21, 2013

Keywords provided by Claudia Schinkoethe, University of Jena:
education program
kidney transplantation
renal transplantation

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency processed this record on September 20, 2017