Trial document




drksid header

  DRKS00017316

Trial Description

start of 1:1-Block title

Title

Analysis of the care situation with regard to the specific immunotherapy in cases of allergic respiratory diseases.

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

Trial Acronym

VerSITA

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

URL of the Trial

https://innovationsfonds.g-ba.de/projekte/versorgungsforschung/versita-versorgungssituation-der-sit-bei-allergischen-atemwegserkrankungen.159

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

Brief Summary in Lay Language

The project VerSITA examines the use of specific immunotherapy in cases of allergic respiratory diseases. Groups of patients which are not optimal treated will be identified. An extensive analysis will be done to describe the recent care situation. Therefore routine data of a statutory health insurance and primary data will be evaluated.

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

Brief Summary in Scientific Language

Objective of the study is an analysis of the care situation of patients with allergic respiratory diseases focusing the specific immunotherapy (SIT) (now mainly called allergen immunotherapy (AIT)). Predictive factors of a deficient care situation will be identified. In addition, further aims are pursued:
- quantifying of the deficient care situation and its potential of optimisation,
- description of symptoms, quality of life and cost of illness in cases of allergic respiratory diseases,
- identification of significant predictive factors for a AIT treatment.
A retrospective, cross-sectional, cohort based study based on a patient survey and routine data of DAK-Gesundheit is used to analyse the care situation.

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

Organizational Data

  •   DRKS00017316
  •   2019/05/21
  •   [---]*
  •   yes
  •   Approved
  •   19-8598-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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

  •   J30.1 -  Allergic rhinitis due to pollen
  •   J30.2 -  Other seasonal allergic rhinitis
  •   J30.3 -  Other allergic rhinitis
  •   J30.4 -  Allergic rhinitis, unspecified
  •   J45.0 -  Predominantly allergic asthma
  •   J45.8 -  Mixed asthma
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   allergic rhinitis and no AIT
    (one-time patient survey and routine data analysis)
  •   allergic rhinitis and AIT (see arm 1)
  •   allergic asthma and no AIT (see arm 1)
  •   allergic asthma and AIT (see arm 1)
  •   allergic rhinitis and allergic asthma and no AIT (see arm 1)
  •   allergic rhinitis and allergic asthma and AIT ((see arm 1)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

by questionnaire and routine data: existing of a deficent care situation regarding AIT

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

Secondary Outcome

by questionnaire and routine data: patient characteristics which correlates with a deficient care situation regarding AIT; health related quality of life; cost of illness

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

  •   Planned
  •   2019/06/20
  •   7000
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

Inclusion criteria for insurred with allergic rhinitis:
in the index period (01.07.2017-30.06.2018)
at least 5 years old,
at least one secure outpatient diagnosis (J30.1; J30.2; J30.3 or J30.4) in at least one quarter,
insured by the DAK Gesundheit in the index period and the previous four years.

Inclusion criteria for insured with allergic asthma:
in the index period (01.07.2017-30.06.2018),
at least 5 years old,
at least secure outpatient diagnosis in at least two quarter or an inpatient diagnosis in at least one quarter,
at least one of the below listed drugs prescribed,
insurred by the DAK Gesundheit in the index period and the previous four years.

ATC-Code asthma medication: R03AA, R03AC, R03AK, R03BA, R03BB, R03BC, R03CB, R03CC, R03DA, R03DC, R03DH, R03DX

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

Exclusion Criteria

none

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Lehrstuhl für Medizinmanagement, Universität Duisburg-Essen
    • Mr.  Prof. Dr.  Jürgen  Wasem 
    • Thea-Leymann-Straße 9
    • 45127  Essen
    • 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 other
    • DAK-Gesundheit
    • Nagelsweg 27-31
    • 20097  Hamburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Deutsche AllergieLiga e.V.
    • Blumenstraße 14
    • 63303  Dreieich
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Lehrstuhl für Medizinmanagement, Universität Duisburg-Essen
    • Ms.  Dr.  Janine  Biermann-Stallwitz 
    • Frau Dr. Janine Biermann-Stallwitz
    • 45127  Essen
    • 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
    • Lehrstuhl für Medizinmanagement, Universität Duisburg-Essen
    • Mr.  Frederik  Valbert 
    • Thea-Leymann-Straße 9
    • 45127  Essen
    • 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
    • Innovationsfond des Gemeinsamen Bundesausschussess (vertreten durch: Deutsches Zentrum für Luft und Raumfahrt e.V. (DLR))
    • Heinrich-Konen-Straße 5
    • 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 planned
  •   [---]*
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.