Trial document





This trial has been registered retrospectively.
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  DRKS00006260

Trial Description

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Title

Health Literacy under the conditions of Systems Medicine concerning mental health problems / subproject of the interdisciplinary consortium project: Systems Medicine and Health Literacy

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Trial Acronym

SysKomp

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Systems medicine draws on an interdisciplinary approach to connect a large amount and variety of biological, neuropsychological, clinical and socio demographic data in order to study the human body as an integrated whole. On this basis, systems medicine aims to advance our understanding as well as the detection, prevention and treatment of diseases.
The success or failure of systems medicine depends on the institutional framework of the healthcare system and on the individual competences to use it. Patients and persons at risk need to know how to take advantage of the new opportunities. This requires sufficient health literacy. Health literacy describes the ability to access, to understand and to appraise health relevant information, as well as the ability to act appropriately.
SysKomp surveys the health literacy of people with mental health problems and their attitudes towards systems medicine. About 300 people between 15 and 40 years old and suffering from early stages of mental disorders will be included in the survey. Taking into account further theoretical and normative reflection, the concept of health literacy will be specified for this type of disorder.
On this basis, recommendations to promote health literacy especially in people with mental health problems will be developed.

Amendment: Due to recruiting problems caused by institutional structural changes, a further early detection centre was included.
Based on the preliminary results (03/16), the planned number of participants was reduced to a minimum of 300.

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Brief Summary in Scientific Language

Mental disorders are one of the most common diseases in today's society. Every year approximately one in three people aged between 18 and 79 in Germany are affected by at least one mental disorder, more than a third of them have more than one diagnosis.
Intense research of valid indicators and risk factors in affective and non-affective mental disorders has been ongoing in the recent years. In long term, this knowledge is aimed to be used in routine medical practice in order to develop and facilitate prevention and early treatment.
The success or failure of systems medicine depends on the individual competences to use it. Patients and persons at risk need to know how to take advantage of the new opportunities. The necessary health literacy is often not sufficient. Due to the growing structural complexity of the health care system and the holistic approach of systems medicine, individuals are facing complex challenges. The medical focus shifts from patients suffering from diseases to persons at risk, the so called healthy ill. It can be expected, that there will be significant difficulties in accessing, understanding, appraising and applying health relevant information in the context of systems medicine.
In terms of such a dynamic environment, the question how individuals can gain sufficient health literacy and ultimately be able to make informed decisions concerning health is becoming increasingly urgent.

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Organizational Data

  •   DRKS00006260
  •   2014/12/22
  •   [---]*
  •   yes
  •   Approved
  •   14-165, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   F00-F99 -  Mental and behavioural disorders
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Interventions/Observational Groups

  •   Help-seeking persons who contact an early detection center for mental disorders for the first time will be aske to asked to fill in the questionnaire on individual health literacy "HLS -EU Q47",questions on Socio-demographic data and their attitude towards innovative diagnostic medical options. Pseudonymous information on clinical findings will be collected separatly.

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Characteristics

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

Cross-sectional survey of individual health literacy of persons with mental health problems (Self - assessment ) using a validated questionnaire: German version of "HLS -EU Q47",
Socio-demographic data and
pseudonymous information on clinical findings

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Secondary Outcome

attitude of people with mental health problems towards innovative diagnostic medical options by qualitative items

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/09/01
  •   300
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   15   Years
  •   40   Years
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Additional Inclusion Criteria

Help-seeking persons who contact an early detection center for mental disorders for the first time and undergo diagnostic examination.
Individuals have consented to participate ( voluntary participation ) . The participant is aged from 15 to 40 years. The participant is fluent in German.

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Exclusion Criteria

At least one inclusion criterion is not the case.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Forschungsstelle Ethik
    • Ms.  Prof. Dr. med.  Christiane  Woopen 
    • Herderstr. 54
    • 50931  Köln
    • Germany
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    • Forschungsstelle Ethik
    • Ms.  Prof. Dr. med.  Christiane  Woopen 
    • Herderstraße 54
    • 50931  Köln
    • Germany
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    • Forschungsstelle Ethik
    • Ms.  Prof. Dr. med.  Christiane   Woopen 
    • Herderstraße 54
    • 50931   Köln
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung
    • 11055  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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* This entry means the parameter is not applicable or has not been set.