Trial document




drksid header

  DRKS00000090

Trial Description

start of 1:1-Block title

Title

Primary prevention of alcohol-related disorders in older migrants - development and evaluation of a transcultural prevention concept

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

MigPräv

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Alcohol-related diseases constitute the diseases with the highest impact in Germany in terms of social medicine. In migrants, alcohol becomes a frequent problem in particular from the age of 50 onwards. By the same token, migrants come up against diverse communicative and administrative barriers in the routine health care system and are not sufficiently reached by offers of help in combating addiction. In addition, preventive behaviour is influenced by cultural differences in terms of how alcohol consumption is evaluated and dealt with. Although health promotion as primary prevention is rated positively, there are not yet any evaluated primary preventive measures for older people.
Thus the project will develop and evaluate a transcultural prevention concept of alcohol-related disorders in older migrants in collaboration with migrants as well as professionals in specialist services for immigrants and addiction.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Background: Alcohol-related diseases constitute the diseases with the highest impact in Germany in terms of social medicine. In migrants, alcohol becomes a frequent problem in particular from the age of 50 onwards. Considering the fact that older migrants are among the most strongly growing population groups in the country, the future socio-political and health economic significance of the problem of alcohol-related disorders in this population group is clear. By the same token, migrants come up against diverse communicative and administrative barriers in the routine health care system and are not sufficiently reached by offers of help in combating addiction. In addition, preventive behaviour is influenced by cultural differences in terms of how alcohol consumption is evaluated and dealt with. Although health promotion as primary prevention is rated positively, there are not yet any evaluated primary preventive measures for older people.

Aims: The central aims of the intended research are to bring about a sensitisation with regard to health-conducive behaviours in terms of alcohol consumption and the prevention or reduction of risky alcohol consumption in older migrants. Furthermore, in the sense of an extended primary prevention, migrants with signs of abuse should be better detected and motivated to reduce their alcohol consumption (primary prevention of alcohol dependency). To this aim, as specific measures, language- and culture-sensitive patient-oriented materials and a specific transcultural prevention concept should be developed and evaluated. For the development and evaluation of the transnational prevention concept, primarily migrants from Turkey, Spain and Italy as well as ethnic German emigrants from the states of the former Soviet Union will be included.

Methodology: The project comprises following sub-steps: 1) Study on the utilisation of the health care system and on alcohol consumption in older migrants, 2) Development of a transcultural prevention concept, 3) randomised controlled implementation study on the evaluation of the transcultural prevention concept, and 4) Development of a transfer concept on the transfer into routine care services.
Through the intervention study, the aim is to show that a transcultural prevention measure concerning alcohol-related disorders, in comparison to a standard measure of primary prevention, leads to better knowledge regarding alcohol-related disorders as well as regarding risk behaviour and prevention behaviour and to more appropriate attitudes towards alcohol and how it is dealt with.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000090
  •   2009/02/24
  •   2008/01/09
  •   yes
  •   Approved
  •   311/07, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   UKF001395  (Register Klinischer Studien des Universitätsklinikums Freiburg)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   healthy persons as well as persons with risky alcohol consumption
  •   Z72.0 -  Tobacco use
  •   F10.1 -  Mental and behavioural disorders due to use of alcohol; Harmful use
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   trans-cultural precvention measures regarding alcohol-related diseases (trans-cultural prevention concept).
    The measure can be offered in the frame of existing courses or as single course and should be held in German. The trans-cultural prevention measure consists of the parts. The first part is a group course regarding alcohol-related disorders as well as regarding risk behaviour and prevention behaviour using specific language and cultural sensitive materials, particularly a specific language and cultural sensitive information brochure. A main facet is that this course is held as conjoint offer by members of both the migration and the addiction counselling services. The second part is the concerted possibility of individual counselling for attendees with problematic alcohol consumption.
  •   Control
    information measure regarding alcohol-related disorders and counselling in the frame of the routine care (TAU)
    The measure can be offered in the frame of existing courses or as single course and should be held in German. During these courses a generally information regarding alcohol and alcohol-related disorders should be given and a conventional information brochure distributed.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Knowledge regarding risk and prevention behaviour

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

a) Attitudes towards alcohol and prevention of alcohol-related disorders, b) alcohol consumption, c) health-related behaviour and d) intercultural cooperation between the specialist services.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2009/05/01
  •   300
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   45   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Elderly migrants (over 45 years) from Turkey, Spain and Italy as well as ethnic German emigrants from the states of the former Soviet Union

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Persons which do not belong to one of the target groups or which are jounger than 44 years

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • UNIVERSITAETSKLINIKUM FREIBURG Abteilung fuer Psychiatrie und Psychotherapie Sektion Klinische Epidemiologie und Versorgungsforschung
    • Mr.  Dr. phil.  Isaac  Bermejo 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • UNIVERSITAETSKLINIKUM FREIBURG Abteilung fuer Psychiatrie und Psychotherapie Sektion Klinische Epidemiologie und Versorgungsforschung
    • Mr.  Dr. phil.  Isaac  Bermejo 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • UNIVERSITAETSKLINIKUM FREIBURG Abteilung fuer Psychiatrie und Psychotherapie Sektion Klinische Epidemiologie und Versorgungsforschung
    • Ms.  Dr. phil.  Daniela  Ruf 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Projektträger im DLR Abt. Gesundheitsforschung
    • Ms.  Dr. phil.  Judith  Hesse-Husain 
    • Heinrich-Konen-Str. 1
    • 53227  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.