Trial document





This trial has been registered retrospectively.
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  DRKS00006350

Trial Description

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Title

The Choice of Renal Replacement Therapy (CORETH) Project:
Patient Participation, Quality of Life, and Economic Consequences

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Trial Acronym

CORETH

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URL of the Trial

http://coreth.uni-halle.de/

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Brief Summary in Lay Language

The CORETH study (Choice of Renal Replacement Therapy) is focused on the two dialysis modalities hemodialysis and peritoneal dialysis. Key questions regarding the medical care explore personal needs and the social conditions of patients: How does the dialysis modality affect their quality of life? Which physical, psychological, mental and social conditions contribute to the choice of the dialysis modality? Furthermore, we want to determine the patients‘ demands for autonomous health-decisions. Finally, there will also be an economic evaluation. The participation of each individual is of great significance in order to eventually improve the medical care for patients and other persons involved. Although every third end-stage renal disease patient could opt for peritoneal dialysis, this decision is made in less than five per cent of cases. The CORETH-project wants to investigate reasons, why until now peritoneal dialysis has been so infrequently used. Possible influencing aspects such as the physical, mental and social disposition have been neglected so far. The CORETH-project aims at gaining new scientific insights about potential deficits of the health care system with respect to dialysis as well as the dialogue between patient and physicians.

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Brief Summary in Scientific Language

From the medical point of view every third patient with end-stage renal disease (ESRD) could choose peritoneal dialysis (PD) instead of hemodialysis (HD). However, the actual proportion of patients receiving PD in Germany is below 5 %. To date, research has neglected the role of psychosocial and cognitive conditions in ESRD as contributing factors to dialysis modality decision making. Hence, the CORETH study aims to examine these conditions with regard to their impact on the choice of dialysis treatment. Furthermore, both modalities will be compared economically.
Two groups of patients will be compared after having chosen PD or HD as permanent treatment. About 1,200 participants from 50 dialysis centres all over Germany will be questioned by a mobile study team. The questionnaires addresses social conditions (social support, social network), psychological factors (depression, autonomy preference), and shared decision making aspects between patients and nephrologists. Furthermore, cognitive functioning (selective attention and task switching) will be tested. For economic evaluation direct and indirect costs of ESRD treatment will be calculated. During a one-year follow-up changes will be examined.
The results will enlighten the causes of the low utilisation of PD up to date and the potential deficits of the German health care system. From the patients’ point of view the results will help to strengthen their participation in the individual process of health related decision making.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006350
  •   2014/07/16
  •   [---]*
  •   yes
  •   Approved
  •   2013-134, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

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

  •   N18.5 -  Chronic kidney disease, stage 5
  •   end-stage renal disease, dialysis treatment
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Interventions/Observational Groups

  •   Hemodialysis patients: Questionnaire survey with two measurement points (T1 = baseline and T2 = 1 year follow-up). Items: psychological, cognitive, social and physically decision determinants towards a specific dialysis modality.

  •   Peritoneal dialysis patients: Questionnaire survey with two measurement points (T1 = baseline and T2 = 1 year follow-up). Items: psychological, cognitive, social and physically decision determinants towards a specific dialysis modality.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Health care system
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

prognostic validity of a multi-factorial model in order to explain variance in decision making determinants with regard to dialysis modality choice from the viewpoint of ESRD-patients

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/05/19
  •   1600
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

patients with ESRD (ICD10:N18.5) of
any cause, undergoing renal replacement therapy
for 6 to 24 month, absence of acute psychiatric disorders, able to read and write German, informed written consent

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Exclusion Criteria

unable or unwilling to give informed consent, age < 18 years, acute psychiatric disorder

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Addresses

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    • Klinik für Innere Medizin II (SP Nephrologie, Rheumatologie und Endokrinologie),Martin-Luther-Universität Halle-Wittenberg
    • Mr.  Prof. Dr.  Matthias  Girndt 
    • Ernst-Grube-Str. 40
    • 06120   Halle (Saale)
    • Germany
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    • Institut für Rehabilitationsmedizin, Martin-Luther-Universität Halle-Wittenberg
    • Mr.  Prof. Dr.  Wilfried  Mau 
    • Magdeburger Str. 8
    • 06097  Halle (Saale)
    • Germany
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    •   Mitantragsteller
    •   [---]*
    •   [---]*
    •   [---]*
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    • Institut für Rehabilitationsmedizin, Martin-Luther-Universität Halle-Wittenberg
    • Ms.  Denise  Neumann 
    • Magdeburger Str. 8
    • 06097  Halle (Saale)
    • Germany
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    • Institut für Rehabilitationsmedizin, Martin-Luther-Universität Halle-Wittenberg
    • Ms.  Denise  Neumann 
    • Magdeburger Str. 8
    • 06097  Halle (Saale)
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung (BMBF) Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/09/30
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Trial Publications, Results and other Documents

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