Trial document




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  DRKS00016021

Trial Description

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Title

Fear of progression in idiopathic Parkinson ́s disease and the detection of influencing sociodemographic, clinical and neuropsychological factors

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Fear of progression is a fear that appears as a reaction to the diagnosis of a disease. Especially, patients with chronical diseases like idiopathic Parkinson’s Diseases or rheumatic symptoms seem to be affected. So far, there is only little research available regarding fear of progression in Parkinson’s disease. It has been shown that fear of progression is associated with the development of anxiety disorders and has a negative impact on patients’ quality of life and depression level.
The aim of this study is to provide further knowledge about the incidence and the mechanisms of fear of progression in patients with Parkinson’s Disease. On the one hand the number of patients with Parkinson’s Disease affected by fear of progression will be ascertained. On the other hand, it will be examined which sociodemographic, clinical and neuropsychological variables are highly correlated with fear of progression.
Therefore, 120 patients with Parkinson’s Disease will be examined while staying as an inpatient in one of the cooperating hospitals (Movement Disorders Clinic, Beelitz-Heilstätten, Germany and Centre of Parkinsonism and Movement Disorders, Paracelsus-Elena Hospital, Kassel, Germany). The testing includes extensive neuropsychological and clinical screening (paper- and pencil-tests, motor examination), self-reporting questionnaires and a short interview between the patient and the examiner. While testing takes place at the cooperating hospitals, the data-analyses will be realised in the department of Medical Psychology | Neuropsychology and Gender Studies at the University Hospital Cologne.

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Brief Summary in Scientific Language

Background: Fear of progression is a reactive and conscious fear that appears either as a reaction to the diagnosis of a disease or during the course of a disease. So far, there is only little research available regarding fear of progression. Some studies, mainly with patients affected by cancer, have shown that fear of progression has a huge clinical impact regarding the development of anxiety disorders as well as on patients’ quality of life and depression levels. Research focussing on fear of progression in patients with chronic diseases found that Parkinson’s Disease (PD) patients (as well as patients with rheumatic diseases) score highest in fear of progression.


Aim: The overall aim of this project is to extensively investigate fear of progression in patients with Parkinson’s Disease. On the one hand, the prevalence of fear of progression in patients with Parkinson's disease will be examined. On the other hand, the impact of sociodemographic, clinical and neuropsychological that are associated with fear of progression will be analysed.


Study design: In a single cross-sectional survey 120 patients will be examined while staying in one of the cooperating hospitals as an inpatient: Movement Disorders Clinic, Beelitz-Heilstätten, Germany and Centre of Parkinsonism and Movement Disorders, Paracelsus-Elena Hospital, Kassel, Germany, respectively. The design contains an elaborated neuropsychological and clinical examination, self-reporting questionnaires and a short semi-structured qualitative interview.



Outcomes: Neuropsychological and clinical examination will be realised using paper-pencil-method. The primary outcome will be fear of progression (operationalized with an established self-reporting questionnaire and by conducting a semi-structured qualitative interview). Secondary outcomes mainly include tests and questionnaires in the domains of sociodemographic, clinical, cognitive and psychiatric parameters.



Analysis: The data management and analyses will take place in the department of Medical Psychology | Neuropsychology and Gender Studies at the University Hospital Cologne. After data collection is completed descriptive analyses, correlation and prediction analyses will be done using the statistics program IBM SPSS Statistics 25. The results of the semi structured qualitative interview will be analysed using MAXQDA 2018.1.

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Organizational Data

  •   DRKS00016021
  •   2019/01/28
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  •   yes
  •   Approved
  •   18-398, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   G20 -  Parkinson disease
  •   Fear of progression
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Interventions/Observational Groups

  •   Cross-sectional study to assess the the prevalence of fear of progression in patients with idiopathic Parkinson's disease and to determine influencing sociodemographic, clinical and neuropsychological factors; single neuropsychological and clinical assessment regarding the specified outcomes; no intervention.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Fear of progression (operationalized with the fear of progression questionnaire (PA-F) by Herschbach et al. (2005) and Waadt et al. (2011); the two-hour examination of this outcome takes place within one scheduled neuropsychological and clinical assessment.

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Secondary Outcome

Disease severity (UPDRS-III, Hoehn and Yahr-Stage); activities of daily living (UPDRS-II); pain (visual analogue scale); globale cognition (MoCA); executive functions (RWT, Key Search, TMT A and B); reasoning (LPS 50+, Subtest 4); depression (HADS-D); anxiety (HADS-D); hypochondria (Whiteley-Index); personality (NEO-FFI); quality of life (PDQ-8); sense of coherence (Sense of Coherence-Scale, SOC-L9); coping/introspection/self-verbalisation/hope/social support/motivation to change (FERUS); healthy literacy (HLS-EU-Q47); knowledge about Parkinson's disease (self-rating on a multi-level analogue scale); the examination of these outcomes takes place within one scheduled two-hour neuropsychological and clinical assessment.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2019/01/29
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Inpatient in the cooperating hospitals (Movement Disorders Clinic, Beelitz-Heilstätten, Germany; Centre of Parkinsonism and Movement Disorders, Paracelsus-Elena Hospital, Kassel, Germany); idiopathic Parkinson's disease with and without cognitive impairment diagnosed by a neurologist/psychiatrist; the patient is able to follow instructions and to complete questionnaires; age: above 50 years; normal or corrected-to normal vision and hearing; German as first language or excellent knowledge of the German language.

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Exclusion Criteria

Severe cognitive impairment that are not compatible with participating in the study (operationalized with the MoCA < 13 points): instructions cannot be realized; unable to consent in study participation; severe/life-threatening comorbidities that are not compatible with participating in the study; acute suicidal tendency.


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Addresses

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    • Medizinische Psychologie | Neuropsychologie und Gender Studies, Uniklinik Köln
    • Ms.  Prof. Dr.  Elke  Kalbe 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Kliniken Beelitz, Neurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson
    • Mr.  Prof. Dr. med.  Georg  Ebersbach 
    • Straße nach Fichtenwalde 16
    • 14547  Beelitz-Heilstätten
    • Germany
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    • Paracelsus-Elena-Klinik Kassel - Neurologisches Akutkrankenhaus
    • Ms.  Prof. Dr. med.  Claudia  Trenkwalder 
    • Klinikstraße 16
    • 34128  Kassel
    • Germany
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    • Medizinische Psychologie | Neuropsychologie und Gender Studies, Uniklinik Köln
    • Ms.  M.A.  Ann-Kristin  Folkerts 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Medizinische Psychologie | Neuropsychologie und Gender Studies, Uniklinik Köln
    • Ms.  M.A.  Ann-Kristin  Folkerts 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Psychologie | Neuropsychologie und Gender Studies, Uniklinik Köln
    • Ms.  Prof. Dr.  Elke  Kalbe 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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