Trial record 13 of 432 for:    Open Studies | kidney transplantation

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Jena
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Claudia Schinkoethe, University of Jena
ClinicalTrials.gov Identifier:
NCT01630824
First received: June 26, 2012
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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: 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 University of Jena:

Primary Outcome Measures:
  • transplant survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of rejections [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • days at hospital [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • blood pressure control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • number of infectious complications [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • quality of life (QoL) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01630824

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

Locations
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
Principal Investigator: Gunter Wolf University of Jena
  More Information

No publications provided

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

Keywords provided by University of Jena:
education program
kidney transplantation
renal transplantation
evaluation

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 29, 2014