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Systematic Evaluation of Predictors of Quality of Life in the Long-term After Solid Organ Transplantation

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 August 2009 by Hannover Medical School.
Recruitment status was:  Recruiting
German Federal Ministry of Education and Research
Information provided by:
Hannover Medical School Identifier:
First received: November 14, 2008
Last updated: August 24, 2009
Last verified: August 2009
A systematic evaluation of predictors of health related quality of life (HRQoL) leads to multiple level of data analysis. The aim of the herein described observational project is to create a transplant patients registry on psychosocial outcomes and to evaluate longitudinally predictors of HRQoL after different types of solid organ transplantation in the long-term. A sample size of 700 participants consisting of all solid organ types is envisioned. Data will be compared with published healthy normative data. Data Evaluation of predictors of HRQoL may guide development of tailored interventions to reduce complications and to further improve outcomes.

Organ Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Systematic Evaluation of Predictors of Quality of Life in the Long-term After Solid Organ Transplantation- a Prospective Cohort Study

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • HRQoL after transplantation [ Time Frame: 5 yrs ]

Secondary Outcome Measures:
  • Social re-integration [ Time Frame: 5 yrs ]

Estimated Enrollment: 700
Study Start Date: February 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients immediately after solid organ transplantation

Inclusion Criteria:

  • Follow-up at our outpatient clinics
  • Written informed consent
  • Sufficient German language skills to read and answer a battery of questionnaires
  • Min 18 years

Exclusion Criteria:

  • Illiteracy
  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: NCT00792064

Contact: Christiane Kugler, PhD ++49.511.532.6586

Hannover Medical School, Clinic für cardias, thoracic, transplantation and vascular surgery Recruiting
Hannover, Germany, 30625
Contact: Christiane Kugler    0049-511-5326586   
Principal Investigator: Christiane Kugler         
Sponsors and Collaborators
Hannover Medical School
German Federal Ministry of Education and Research
Principal Investigator: Christiane Kugler, PhD Clinic for Cardiac, Thoracic, Transplantation and
  More Information

Responsible Party: Dr. rer. biol. hum. Christiane Kugler, Hannover Medical School Identifier: NCT00792064     History of Changes
Other Study ID Numbers: IRB No_378
Study First Received: November 14, 2008
Last Updated: August 24, 2009

Keywords provided by Hannover Medical School:
quality of life
adverse effects processed this record on May 25, 2017