Trial document




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  DRKS00010838

Trial Description

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Title

Workability, Health Literacy and Life Quality of Patients with Common Variable Immunodeficiency Disorders

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Trial Acronym

WoHL-CVID

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URL of the Trial

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Brief Summary in Lay Language

Patients with common variable immunodeficiency suffer from an impaired immune system due to reduced antibody production. As a consequence they are often affected by colds, sinusitis, pneumonia and other infections. For a substantial proportion of CVID patients, immunoglobulin substitution can improve these symptoms. However, infection frequency, hospital admissions as well as days absent from work are still elevated among CVID patients compared to healthy individuals. Various studies also reported an impaired quality of life among CVID patients compared to healthy individuals. Little research has been performed to evaluate the impact of the disease on the workability of patients. Therefore, this study will investigate whether reduced workability is a relevant topic among the CVID patient population. In that context we will assess the health literacy of CVID patients as well as other factors with putative impact on their workability as well as their quality of life. Results of this study shall contribute to the development of a program to improve health literacy as well as workability of patients with CVID.

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Brief Summary in Scientific Language

Common variable immunodeficiency (CVID) is the most prevalent primary immune deficiency disorder in adults. Because of impaired antibody provision, CVID is linked with recurrently infections of the upper and lower respiratory tract and can lead to restricted lung function, autoimmune diseases, granuloma and cancer. Immunoglobulin substitution leads to a significant improvement of symptoms in the majority of patients. However, an increased susceptibility to viral infections often persists. Overall, the number of infections, hospitalizations or days of absence from work due to this condition is higher in patients with CVID and on average their quality of life is lower than in healthy persons. Until now, little is known about the impact of the disease on patients’ workability. The objective of this exploratory study is to find out if subgroups of CVID patients exist who are characterized by a limited workability and which factors contribute to it. In this context we will assess health literacy and other factors which could have an impact on limited workability and reduced life quality. The results of this study will support the development of a patient program fostering patients with CVID to cope with their disease.

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Organizational Data

  •   DRKS00010838
  •   2016/07/19
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  •   yes
  •   Approved
  •   256/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1185-3874 
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Health Condition or Problem studied

  •   D83 -  Common variable immunodeficiency
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Interventions/Observational Groups

  •   Patients with common variable immunodeficiency (CVID) complete one questionnaire in terms of their workability, quality of life, health literacy, infections and socio-demographic characteristics.
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Characteristics

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

Description of the workability of patients with common variable immunodeficiency (CVID) assessed by the patient self-evaluated “Workability Index” (WAI) and by parts of the “Indicators of the Rehabilitation Status” (IRES).

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Secondary Outcome

(1) Statistical correlation of workability, quality of life and health literacy. (2) Identification of risk groups of impaired workability. (3) Data generation for the development of a patient program to enhance the health literacy and to foster the workability of patients with CVID.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/07/25
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Informed consent available

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Exclusion Criteria

(1) Patient with a serious progressive course of disease and short life expectancy. (2) Insufficient comprehension of German language.

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Addresses

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    • Universitätsklinikum Freiburg, Centrum für Chronische Immundefizienz (CCI) am Zentrum für Translationale Zellforschung (ZTZ), Clinical Research Unit
    • Ms.  PD Dr.  Alexandra  Nieters M.P.H 
    • Breisacher Str. 115
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Centrum für Chronische Immundefizienz (CCI) am Zentrum für Translationale Zellforschung (ZTZ), Clinical Research Unit
    • Ms.  PD Dr.  Alexandra  Nieters M.P.H 
    • Breisacher Str. 115
    • 79106  Freiburg
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Universitätsklinikum Freiburg, Centrum für Chronische Immundefizienz (CCI) am Zentrum für Translationale Zellforschung (ZTZ), Clinical Research Unit
    • Ms.  PD Dr.  Alexandra  Nieters M.P.H 
    • Breisacher Str. 115
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • BMBF Bundesministerium für Bildung und Forschung
    • 53175  53175 Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/11/18
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Trial Publications, Results and other Documents

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