Trial document





This trial has been registered retrospectively.
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  DRKS00016603

Trial Description

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Title

Evaluation of the impact of a disease specific informational meeting on disease related knowledge, health conditions and disease perception of patients with systemic lupus erythematosus (SLE) and granulomatosis with polyangiitis (GPA)

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Trial Acronym

InfoLupGraPA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study intends to determine the effect of a disease-specific informational meeting with respect to well-being, knowledge and burden of disease in patients with severe autoimmune diseases (systemic lupus erythematosus and granulomatosis with polyangiitis). Participants have to fill in a questionnaire to record the strength of their symptoms and their health impairment as well as the profoundness of their knowledge about their disorder. The survey will be repeated after three month to clarify, how much of the information was kept, and whether the given information resulted in any change of disease specific behavior. The results will be compared with a group of patients who will attend the informational meeting after a waiting period of three months. Potential participants are patients of the state Saxony Anhalt.

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Brief Summary in Scientific Language

In a prospective, randomised controlled study, patients with systemic lupus erythematosus and granulomatosis with polyangiitis are surveyed by means of a questionnaire with rexpect to their disease perception, their health condition and their diseases specific knowledge. Anfterwards, the patients take part in an informational one-day meeting that provides them with information regarding their disease, the respective treatment and life style modifications that are recommended in the context of their disorder. The survey will be repeated after the meeting as well as three months later to determine the long-term impact of the intervention. A second sample of patients who are on a waiting list of three months before attending the same informational meeting serves as a control group. Patients will be recruted from the whole area of the state Saxony Anhalt.

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Organizational Data

  •   DRKS00016603
  •   2019/10/10
  •   [---]*
  •   yes
  •   Approved
  •   2019-021, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   M32.9 -  Systemic lupus erythematosus, unspecified
  •   M31.3 -  Wegener granulomatosis
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Interventions/Observational Groups

  •   patients with systemic lupus erythematosus and granulomatosis with polyangiitis: Intervention group
  •   patients with systemic lupus erythematosus and granulomatosis with polyangiitis: Waiting list-control group
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

disease knowledge

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Secondary Outcome

perception of disease,
health condition

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/05/27
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

Valid diagnosis of
1.) systemic lupus erythematosus or
2.) granulomatosis with polyangiitis

- Adult patients of at least 18 years

-Fluent understandig of German language

- Willingness to takt part in the informational meeting and the survey

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Exclusion Criteria

- High disease activity or comorbid condition that prevents the patient from being capable to take part in the intervention

- Severe reduction of intelligence that renders the perception of information impossible.

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Addresses

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    • Universitätsklinikum Halle (Saale)Klinik für Innere Medizin II
    • Mr.  apl.Prof.Dr. med. habil.  Gernot  Keyßer 
    • Ernst-Grube-Str. 40
    • 06120  Halle (Saale)
    • Germany
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    • Universitätsklinikum Halle (Saale)Department für Innere MedizinUniversitätsklinik und Poliklinik für Innere Medizin II
    • Mr.  Dr. med.  Christoph Schäfer 
    • Ernst-Grube-Str. 40
    • 06017  Halle (Saale)
    • Germany
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    • Universitätsklinikum Halle (Saale)Department für Innere MedizinUniversitätsklinik und Poliklinik für Innere Medizin II
    • Ms.  Dr. med.  Nancy  Zipfel 
    • Ernst-Grube-Str. 40
    • 06097  Halle (Saale)
    • Germany
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    • Universitätsklinikum Halle (Saale)Department für Innere MedizinKlinik für Innere Medizin II
    • Mr.  apl. Prof. Dr. med.  Gernot  Keyßer 
    • Ernst-Grube-Str. 40
    • 06097  Halle (Saale)
    • Germany
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    • Universitätsklinikum Halle (Saale)Department für Innere MedizinKlinik und Poliklinik für Innere Medizin II
    • Mr.  Florian  Schmidt 
    • Ernst-Grube-Str. 40
    • 06097  Halle (Saale)
    • Germany
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    • Universitätsklinikum Halle (Saale)Department für Innere MedizinKlinik und Poliklinik für Innere Medizin II
    • Ms.  Annika  Pilz 
    • Ernst-Grube-Str. 40
    • 06097  Halle (Saale)
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Halle (Saale)Klinik für Innere Medizin II
    • Mr.  apl.Prof.Dr. med. habil.  Gernot  Keyßer 
    • Ernst-Grube-Str. 40
    • 06120  Halle (Saale)
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Ethik-Votum
  •   Studienprotokoll
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* This entry means the parameter is not applicable or has not been set.