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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00792064
Other study ID # IRB No_378
Secondary ID
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


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
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