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

NCT ID: NCT00792064

Last Updated: 2009-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2014-07-31

Brief Summary

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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

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Conditions

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Organ Transplantation Anxiety Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Kidney-Tx-recipients

No interventions assigned to this group

2

Liver-Tx-recipients

No interventions assigned to this group

3

Heart-Tx-recipients

No interventions assigned to this group

4

Lung-Tx-recipients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Hannover Medical School

Principal Investigators

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Christiane Kugler, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinic for Cardiac, Thoracic, Transplantation and

Locations

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Hannover Medical School, Clinic für cardias, thoracic, transplantation and vascular surgery

Hanover, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Christiane Kugler, PhD

Role: CONTACT

++49.511.532.6586

Facility Contacts

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Christiane Kugler

Role: primary

0049-511-5326586

Other Identifiers

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IRB No_378

Identifier Type: -

Identifier Source: org_study_id

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