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

Depression Clinical Trial

Official title:

Systematic Evaluation of Predictors of Quality of Life in the Long-term After Solid Organ Transplantation- a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00792064
• Other study ID #: IRB No_378
• Status: Recruiting
• Phase: N/A
• First received: November 14, 2008
• Last updated: August 24, 2009
• Start date: February 2009
• Est. completion date: July 2014

Study information

• Verified date: August 2009
• Source: Hannover Medical School
• Contact: Christiane Kugler, PhD
• Phone: ++49.511.532.6586
• Email: Kugler.Christiane[@]mh-hannover.de
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: July 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety
• Depression
• Organ Transplantation

Locations

Country	Name	City	State
Germany	Hannover Medical School, Clinic für cardias, thoracic, transplantation and vascular surgery	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HRQoL after transplantation		5 yrs	No
Secondary	Social re-integration		5 yrs	No