Back to resultsDevelopment and Effects of a Structural Education Program in Adult Kidney Transplant Recipients
Primary Purpose
Chronic Kidney Disease
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Structured education program
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Kidney Disease focused on measuring education program, kidney transplantation, renal transplantation, evaluation
Eligibility 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
Sites / Locations
- Department of Nephrology, University of JenaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Education
Control
Arm Description
Kidney transplant recipients, who undergo the structured education program
Kidney transplant recipients without structured education programm
Outcomes
Primary Outcome Measures
transplant survival
Secondary Outcome Measures
number of rejections
days at hospital
blood pressure control
number of infectious complications
quality of life (QoL)
Full Information
NCT ID
NCT01630824
First Posted
June 26, 2012
Last Updated
May 21, 2013
Sponsor
University of Jena
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT01630824
Brief Title
Development and Effects of a Structural Education Program in Adult Kidney Transplant Recipients
Official Title
Development an Effects of a Structural Education Programm in Adult Kidney Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
education program, kidney transplantation, renal transplantation, evaluation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Education
Arm Type
Other
Arm Description
Kidney transplant recipients, who undergo the structured education program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Kidney transplant recipients without structured education programm
Intervention Type
Other
Intervention Name(s)
Structured education program
Intervention Description
structured education program after kidney transplantation
Primary Outcome Measure Information:
Title
transplant survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
number of rejections
Time Frame
2 years
Title
days at hospital
Time Frame
2 years
Title
blood pressure control
Time Frame
2 years
Title
number of infectious complications
Time Frame
2 years
Title
quality of life (QoL)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Schinkoethe
Phone
004936419324623
Email
claudia.schinkoethe@med.uni-jena.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunter Wolf
Organizational Affiliation
University of Jena
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrology, University of Jena
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07749
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Schinkoethe
Phone
004936419324623
Email
claudia.schinkoethe@med.uni-jena.de
12. IPD Sharing Statement
Learn more about this trial
Development and Effects of a Structural Education Program in Adult Kidney Transplant Recipients
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