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

This study is currently recruiting participants.
Verified August 2009 by Hannover Medical School
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00792064
First received: November 14, 2008
Last updated: August 24, 2009
Last verified: August 2009
History of Changes
  Purpose

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
Organ Transplantation
Anxiety
Depression

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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression
U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • HRQoL after transplantation [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social re-integration [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
1
Kidney-Tx-recipients
2
Liver-Tx-recipients
3
Heart-Tx-recipients
4
Lung-Tx-recipients

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: November 14, 2008
Last Updated: August 24, 2009
Health Authority: Germany: Federal Ministry of Education and Research

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

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
 Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on May 23, 2013