Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 14, 2008
First Posted Date November 17, 2008
Last Update Posted Date August 25, 2009
Study Start Date February 2009
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 14, 2008)
HRQoL after transplantation [ Time Frame: 5 yrs ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 14, 2008)
Social re-integration [ Time Frame: 5 yrs ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Systematic Evaluation of Predictors of Quality of Life in the Long-term After Solid Organ Transplantation
Official Title Systematic Evaluation of Predictors of Quality of Life in the Long-term After Solid Organ Transplantation- a Prospective Cohort Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients immediately after solid organ transplantation
Condition
  • Organ Transplantation
  • Anxiety
  • Depression
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Kidney-Tx-recipients
  • 2
    Liver-Tx-recipients
  • 3
    Heart-Tx-recipients
  • 4
    Lung-Tx-recipients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 14, 2008)
700
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00792064
Other Study ID Numbers IRB No_378
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. rer. biol. hum. Christiane Kugler, Hannover Medical School
Study Sponsor Hannover Medical School
Collaborators German Federal Ministry of Education and Research
Investigators
Principal Investigator: Christiane Kugler, PhD Clinic for Cardiac, Thoracic, Transplantation and
PRS Account Hannover Medical School
Verification Date August 2009