Trial document




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  DRKS00004241

Trial Description

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Title

Culture-sensitive information for patients with migration background and a chronic disease

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Trial Acronym

KULTINFO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Many people have a migration background in Germany. They are only insufficiently reached by existing health offers. In the study, culture-sensitive patient information was developed. It was examined whether culture-sensitive patient information has a higher subjective value than standard-translated information. Patients with a Turkish, Polish, Russian or Italian migration background with a diagnosis of depressive disorder or chronic low back pain were included in the study. The study provides an empirically tested answer to the question of whether culture-sensitive patient information is evaluated as more useful by
migrants than translated information materials without cultural adaptation.

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Brief Summary in Scientific Language

Background:
Of the approx. 15 million persons with a migration background living in Germany (19% of the population), many are only insufficiently reached by existing health offers. In the literature, the necessity for culturally adapted information materials for patients with a migration background is often cited as a method for improving health care.
Aim and research question:
In the study, culture-sensitive patient information was developed and evaluated for patients with a migration background and chronic disease (depression or chronic low back pain). In this respect, it was examined whether culture-sensitive patient information has a higher subjective usefulness than standard-translated information.
Methods:
The implementation and evaluation of culture-sensitive patient information took place in the framework of a double-blind randomised-controlled study in four study centres (Freiburg/Lörrach; Leipzig; Hamburg; Oberhausen/Mülheim/Duisburg) with patients with a Turkish, Polish, Russian or Italian migration background with a diagnosis of depressive disorder or chronic low back pain. In the intervention group, culture-sensitive patient information was handed out to the patient within the physician consultation. In the control group, standard-translated patient information was applied. The patients were surveyed by means of nationally and internationally established, language- and culture-adapted questionnaires following the index consultation (T0) as well as after 8 weeks (T1) and 6 months (T2). In this respect, besides the measurement of the primary dependent variable (subjective usefulness), data on secondary dependent variables was also gathered. Additionally, the GPs were surveyed with regard to the practical relevance of culture-sensitive patient information.
Implementation:
At the beginning of the project, the disease-specific patient information on depression and chronic low back pain were developed and translated into the target languages. This standard-translated patient information was then be adapted in focus groups taking into account migration-, language-, and culture-specific aspects and developed further into culture-sensitive versions of patient information. The participating GPs were sought out by the four centre coordinators in their practices, from where they were instructed with regard to implementing the study. Following this, they were provided with the patient information in the languages relevant to the study. The randomisation and survey of the patients took place in the leading study centre in Freiburg.
Expected results:
The study provides an empirically tested answer to the question of whether culture-sensitive patient information is evaluated as more useful by migrants than translated information materials without cultural adaptation.

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Organizational Data

  •   DRKS00004241
  •   2013/04/17
  •   [---]*
  •   yes
  •   Approved
  •   375/10, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1135-8043 
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Health Condition or Problem studied

  •   F33 -  Recurrent depressive disorder
  •   F32 -  Depressive episode
  •   F34.1 -  Dysthymia
  •   M54.5 -  Low back pain
  •   M54.8 -  Other dorsalgia
  •   M54.9 -  Dorsalgia, unspecified
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Interventions/Observational Groups

  •   translated and culturally adapted information material
  •   translated information material without cultural adaptation
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Perceived usefullness of patient information material assessed after consultation (T0; Usefulness Scale for Patient Information Material [USE])

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Secondary Outcome

Perceived Usefullness (USE) 8 weeks (T1) and 6 month (T2) after index consultation;
Knowledge of disease (self-constructed items) T0, T1, T2;
Perceived Cultural Sensitivity (self-constructed items) T0; Behaviour Change (self-constructed items) T1, T2; Perception of Disease (Brief Illness Perception Questionnaire, Brief-IPQ) T0, T1, T2; Symptoms of Depression/back pain (Patient Health Questionnaire, PHQ-9/Core-Set) T0, T1, T2; Acceptance of Disease and Treatment (self-constructed items) T0, T1, T2; Adherence (Medical Outcomes Study General Adherence Items) T1, T2; Satisfaction with physician (ZAPA) T0, T1, T2;
Health service utilization (self-constructed items) T1, T2;
Quality of Life (WHO-Five Well-being Index, WHO-5) T0, T1, T2;
Acculturation (Stephension Multigroup Acculturation Scale, SMAS) T0

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2013/06/21
  •   480
  •   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 a Turkish, Polish, Russian or Italian
migration background with a diagnosis of depressive disorder or chronic low back pain.

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Exclusion Criteria

illiteracy

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Addresses

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    • Universitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie, AG Psychotherapie- und Versorgungsforschung
    • Mr.  Dr.   Lars P.  Hölzel 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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    • Parkklinik Wiesbaden Schlangenbad
    • Mr.  Dr.  Lars P.  Hölzel 
    • Rheingauer Str. 47
    • 65388  Schlangenbad
    • Germany
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    • Universitätsklinikum Freiburg,Klinik für Psychiatrie und Psychotherapie,AG Psychotherapie und Versorgungsforschung
    • Ms.  Dipl.-Psych.  Zivile  Ries 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/08/31
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* This entry means the parameter is not applicable or has not been set.