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

August 24, 2009 updated by: Hannover Medical School

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Recruiting
        • Hannover Medical School, Clinic für cardias, thoracic, transplantation and vascular surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients immediately after solid organ transplantation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HRQoL after transplantation
Time Frame: 5 yrs
5 yrs

Secondary Outcome Measures

Outcome Measure
Time Frame
Social re-integration
Time Frame: 5 yrs
5 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

November 14, 2008

First Submitted That Met QC Criteria

November 14, 2008

First Posted (Estimate)

November 17, 2008

Study Record Updates

Last Update Posted (Estimate)

August 25, 2009

Last Update Submitted That Met QC Criteria

August 24, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB No_378

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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