Trial document




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  DRKS00005821

Trial Description

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Title

Care of patients with a lung transplantation - a study

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Trial Acronym

ELD-BeoNet-registry

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patientes with ELD (endstage lung disease) requiring special and intensive care. In germany there is a big grap in terms of patient-related treatment resultats and economic impact.

The management and the multi-disciplinary care of the ELD disease is reliant on the support by the acteurs of the care system. So aim of the study is to determine resource consumption, cost effects and effectiveness of treatment on ELD. This is achieved by merging data from settlement system of the doctors practice, the electronic patient record and by questionnaires filled out by the patient.

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Brief Summary in Scientific Language

Aim:
description of health- and economic-related effects of ELD

1. estimate the impact of health and economic aspects of ELD
2. optimisation of a cross-sectoral health care model for patientes with ELD
3. building a database for sectional and longitudinal studies in health care research to improve standard and specialised care

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Organizational Data

  •   DRKS00005821
  •   2014/04/23
  •   [---]*
  •   yes
  •   Approved
  •   1457-2012, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   J84 -  Other interstitial pulmonary diseases
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Interventions/Observational Groups

  •   target group 1: transplanted patients

    Survey with questions conerning quality of life and use of services takes place every three months.

    In addition, data from the electronic patient record will be collected. This data will collected monthly. 2015, the data will be exported daily.

    The study is monocentric since 2016.
  •   target group 2: patients on a transplantation waiting list

    Survey with questions conerning quality of life and use of services takes place every three months.

    In addition, data from the electronic patient record will be collected. This data will collected monthly. 2015, the data will be exported daily.

    The study is monocentric since 2016.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Health care system
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The patient will be recruted in the doctors office or in the clinic. Every three months the patients will be fill out a questionnaire. the questionnaire includes questions on their current state of health, their quality of life (EuroQol), their using behaviour of service offers and questions of their current job situation.

In addition, data will be collected from the electronic patient record. This data will be merged with the primary data. This study is a long-term study.

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Secondary Outcome

Besides the health-related aspects their also will be considered economic aspects. Cost analysis will be a special and important second outcome parameter.

The necessary data will be collected every three months. Furthermore data from the electronic patient record will be collected every month. This data will be merged with the primary data. This study is a long-term study.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2016/01/04
  •   420
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

ICD-10 J84, over 18 years, german-speaking person

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Exclusion Criteria

no ICD-10 J84, not over 18 years, not a german-speaking person

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Addresses

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  Dr. med., MPH  Heidrun  Lingner 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  Dr. med., MPH  Heidrun  Lingner 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung - BMBF
    • Hannoversche Straße 28-30
    • 10115   Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.