Trial document




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  DRKS00006001

Trial Description

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Title

Improving the detection of psychosomatic co-morbidity in general practice - a pilot project

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Many studies highlight the impact of psychosomatic comorbidity on health care utilisation in general practice. Patients with depression, anxiety and somatisation are frequently contacting their general practitioners and specialists and have more days of disability than patients without psychosomatic comorbidity. These patients remain under-recognised despite the high relevance for patient management in primary care. We aim to develop an educational intervention for general practitioners to improve the communication and detection rate of patients with enhanced psychosomatic comorbidity. This is designed as a pilot project. Six practices with an educational intervention will be compared with six practices without intervention (usual care). Patients will fill in a psychometric questionnaire in the waiting room (t1) and three months after inclusion (t2). The general practitioner will rate the psychosomatic comorbidity of the patient after the consultation on a visual analogue scale (VAS) from 0 to 10. We aim to include 20 patients per practice, in total 240 patients (with follow-up). We will compare the correlations between the general practitioners estimation of the psychosomatic comorbidity of their patients and the patients´ self-rating (intervention group versus usual care).

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Brief Summary in Scientific Language

Background: Many studies highlight the impact of psychosomatic comorbidity on health care utilisation in general practice. Patients with depression, anxiety and somatisation are frequently contacting their general practitioners and specialists and have more days of disability than patients without psychosomatic comorbidity. These patients remain under-recognised despite the high relevance for patient management in primary care.
Aim: To develop an educational intervention for general practitioners to improve the communication and detection rate of patients with enhanced psychosomatic comorbidity. This is designed as a pilot project.
Design: Cluster randomised controlled trial with twelve general practices. Six practices with an educational intervention will be compared with six practices without intervention (usual care). Patients will fill in a psychometric questionnaire in the waiting room (t1) and three months after inclusion (t2). The general practitioner will rate the psychosomatic comorbidity of the patient after the consultation on a visual analogue scale (VAS) from 0 to 10. We aim to include 20 patients per practice, in total 240 patients (with follow-up).
Questionnaire: Patient Health Questionnaire (PHQ-D, German version), Big-Five-Inventory, Autonomy Preference Index.
Analysis: Descriptive and explorative analysis. Comparison of correlation coefficients between the general practitioners estimation of the psychosomatic comorbidity of their patients and the patients´ self-rating (intervention group versus usual care)

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Organizational Data

  •   DRKS00006001
  •   2014/03/19
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  •   yes
  •   Approved
  •   15/14, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   F32.1 -  Moderate depressive episode
  •   F45.0 -  Somatization disorder
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Interventions/Observational Groups

  •   Educational intervention (to optimise communication with patients suspected to suffer from psychosomatic co-morbidity; to improve diagnostic competencies; to enhance detection rate of psychosomatic co-morbidity)
  •   usual care
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Detection rate of psychosomatic co-morbidity

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Secondary Outcome

No secondary oucomes.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2014/03/10
  •   240
  •   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

At least 18 years,
Ability to read German language,
Agreement to the study

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Exclusion Criteria

younger than 18 years,
not able to read German language

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Allgemeinmedizin
    • Mr.  Prof. Dr. med.  Antonius  Schneider 
    • Orleansstr. 47
    • 81667  München
    • Germany
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    • Institut für AllgemeinmedizinKlinikum rechts der Isar, TU München
    • Mr.  Prof. Dr. med.  Antonius  Schneider 
    • Orleansstr. 47
    • 81667  München
    • Germany
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    • Institut für AllgemeinmedizinKlinikum rechts der IsarTU München
    • Mr.  Prof. Dr. med.  Antonius  Schneider 
    • Orleansstr. 47
    • 81667  München
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Allgemeinmedizin
    • Mr.  Prof. Dr. med.  Antonius  Schneider 
    • Orleansstr. 47
    • 81667  München
    • Germany
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Status

  •   Recruiting complete, follow-up complete
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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.