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

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ClinicalTrials.gov Identifier: NCT00792064
Recruitment Status : Unknown
Verified August 2009 by Hannover Medical School.
Recruitment status was:  Recruiting
First Posted : November 17, 2008
Last Update Posted : August 25, 2009
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
Hannover Medical School

Brief Summary:
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.

Condition or disease
Organ Transplantation Anxiety Depression

Study Type : Observational
Estimated Enrollment : 700 participants
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
Study Start Date : February 2009
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
Kidney-Tx-recipients
2
Liver-Tx-recipients
3
Heart-Tx-recipients
4
Lung-Tx-recipients



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

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


Information from the National Library of Medicine

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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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00792064


Contacts
Contact: Christiane Kugler, PhD ++49.511.532.6586 Kugler.Christiane@mh-hannover.de

Locations
Germany
Hannover Medical School, Clinic für cardias, thoracic, transplantation and vascular surgery Recruiting
Hannover, Germany, 30625
Contact: Christiane Kugler    0049-511-5326586    kugler.christiane@mh-hannover.de   
Principal Investigator: Christiane Kugler         
Sponsors and Collaborators
Hannover Medical School
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Christiane Kugler, PhD Clinic for Cardiac, Thoracic, Transplantation and

Responsible Party: Dr. rer. biol. hum. Christiane Kugler, Hannover Medical School
ClinicalTrials.gov Identifier: NCT00792064     History of Changes
Other Study ID Numbers: IRB No_378
First Posted: November 17, 2008    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009

Keywords provided by Hannover Medical School:
quality of life
adverse effects