Development and Effects of a Structural Education Program in Adult Kidney Transplant Recipients
Development an Effects of a Structural Education Programm in Adult Kidney Transplant Recipients
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 26, 2012
CompletedFirst Posted
Study publicly available on registry
June 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedMay 22, 2013
May 1, 2013
2 years
June 26, 2012
May 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
transplant survival
2 years
Secondary Outcomes (5)
number of rejections
2 years
days at hospital
2 years
blood pressure control
2 years
number of infectious complications
2 years
quality of life (QoL)
2 years
Study Arms (2)
Education
OTHERKidney transplant recipients, who undergo the structured education program
Control
NO INTERVENTIONKidney transplant recipients without structured education programm
Interventions
Eligibility Criteria
You may qualify if:
- being over 18 years recently had a kidney transplantation able to speak, write and understand german willing to participate regular visits after kidney transplantation
You may not qualify if:
- severe complications after recent kidney transplantation early loss of the kidney allograft severe allograft dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Jenalead
- Novartiscollaborator
Study Sites (1)
Department of Nephrology, University of Jena
Jena, Thuringia, 07749, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gunter Wolf
University of Jena
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med. Claudia Schinkoethe
Study Record Dates
First Submitted
June 26, 2012
First Posted
June 28, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2014
Last Updated
May 22, 2013
Record last verified: 2013-05