Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00013100

Trial Description

start of 1:1-Block title

Title

Drug consumption, especially self medication among overindepted citizens in North Rhine-Westphalia

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

Trial Acronym

ARSEMÜ

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

The deductible to fill a prescription for drugs can be challenging for overindepted citizens. Moreover it is possible that the high prevalence of diseases and health problems among overindepted people leads to a frequent use and a high self-medication with painkillers, sleeping pills and sedatives. Both national and international scientific studies dealing with the drug consumption, especially self-medication of overindepted citizens, are missing. That is why this study aims at identifying the drug consumption of overindepted citizens in North Rhine-Westphalia. In addition, the importance of potential impact factors should be examined. The objective is to inform and support overindepted people and thus optimize the handling of drugs. A written survey was distributed to more than 1600 overindepted citizens by staff of debtor and insolvency advisory ofiices.

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

Brief Summary in Scientific Language

The deductible to fill a prescription for drugs can be challenging for overindepted citizens. Moreover it is possible that the high prevalence of diseases and psychosomatic problems among overindepted people leads to a frequent use and a high self-medication with painkillers, sleeping pills and sedatives. Both national and international scientific studies dealing with the drug consumption, especially self-medication of overindepted citizen, are missing. That is why this study aims at identifying and quantifying the drug consumption of overindepted citizens in North Rhine-Westphalia. In addition, the importance of potential impact factors should be examined. The objective is to inform and support overindepted people and thus optimize the handling of drugs. A written, standardized survey was distributed to more than 1600 overindepted citizens by staff of debtor and insolvency advisory ofiices.

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

Organizational Data

  •   DRKS00013100
  •   2017/10/23
  •   [---]*
  •   yes
  •   Approved
  •   167/17, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   R52 -  Pain, not elsewhere classified
  •   F45.9 -  Somatoform disorder, unspecified
  •   self-medication
  •   drug consumption
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The study aims at identifying and quantifying the drug consumption of overindepted citizens in North Rhine-Westphalia. Besides the importance of potential impact factors should be examined.
    A written, standardized survey was distributed to more than 1600 overindepted citizens by staff of debtor and insolvency advisory ofiices. The participants sent back the completed surveys in the enclosed post-paid envelope.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

This study aims at measuring the drug consumption of overindepted people and identifying problems of supply as well as barriers to healthcare.
A standardized, written survey has been handed out in October 2017 by workers of deptor and insolvency advisory offices in North Rhine-Westphalia to about 1600 overindepted citizens.

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

Secondary Outcome

Moreover it should be gathered how overindepted people handle barriers in the access to drugs. Differences in drug consumption depending on age, sex, migration background and level of education should be identified.
A standardized, written survey has been handed out in September 2017 by workers of deptor and insolvency advisory offices in North Rhine-Westphalia to about 1600 overindepted citizens.

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

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/07/18
  •   1600
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

Overindepted people enclosed in the study have to keep at least the second individual counselling at an deptor advisory office in North Rhine-Westphalia. Moreover it's necessary that the person is the main one in the household to get advises (only one survey per household) and he/she has to be at least 16 years old.

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

Exclusion Criteria

Overindepted people who show up at the debtor advisory office for the first time or who are younger than 16 years old have not been enclosed in the study. Besides people with other members of the household, who already received the survey, have been excluded.

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Landeszentrum Gesundheit NRW
    • Gesundheitscampus-Süd 9
    • 44801  Bochum
    • 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
    • Institut für Hausarztmedizin, medizinische Fakultät der Universität Bonn
    • Ms.  Prof. Dr.  Eva  Münster 
    • Sigmund-Freud-Str. 25
    • 53105  Bonn
    • 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
    • Institut für Hausarztmedizin, medizinische Fakultät der Universität Bonn
    • Ms.  Prof. Dr.  Eva   Münster 
    • Sigmund-Freud-Str. 25
    • 53105  Bonn
    • 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
    • Landeszentrum Gesundheit NRW
    • Gesundheitscampus-Süd 9
    • 44801  Bochum
    • 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 complete
  •   2017/10/31
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.