Trial document





This trial has been registered retrospectively.
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  DRKS00012387

Trial Description

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Title

Investigating the health care situation of cholinergic urticaria patients

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Trial Acronym

VERSICholU

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this project is to investigate the journey of patients suffering from cholinergic urticaria in the medical health care system in Germany. Only by better understanding their pathways in the medical healthcare network, it will be possible to control the patient’s treatment more accurately and thereby generating an improved treatment of patients with cholinergic urticaria.
Hypothesis are inter alia:
- A high percentage of patients have consulted no or just very late specialized medical doctors due to their disease
- A substantial percentage of patients does not receive medical care
- A high percentage of patients is not satisfied with both the treatment itself and its attending physician
- The carried out treatment often differs from the medical guideline’s references
Important target criteria of this inquiry are:
- Amount of consulted physicians
- Qualification of consulted physicians
- Guideline corresponding treatment
- Patient satisfaction with the attending physicians
- General satisfaction with the treatment
- Influencing factors in the decision making process of patients
The planned survey involves a two-step project:
1. Retrospective data evaluation:
In this subproject, records of cholinergic urticaria patients from the allergy center of the Charité shall be analyzed in oder to improve the characterization and recording of previous therapeutic interventions. The thereby gathered data shall assist with the developing of questions for the online patient survey.
2. Online patient survey:
Aim of this survey are not the patients of the Charité, but all cholinergic urticaria patients in Germany to gain a total overview of the care situation of cholinergic urticaria patients in Germany.

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Brief Summary in Scientific Language

Cholinergic urticaria patients either do not consult physicians or only with a delay of many years. It is suspected that this mainly involves general partitioners and only infrequent and late specialists like dermatologist or allergists. On the whole the treatment’s quality appears to be low and the patient’s satisfaction not adequate. The aim of this project is to elucidate and to better understand the pathways cholinergic urticaria patients take in the medical health care system in Germany. Until now, it is unclear which percentage of patients consults a general practitioner at first and which percentage of those is then referred to a specialist or how many patients directly seek advice from specialists. Furthermore, its remains unclear which reasons are important for consulting doctors.
Only by better understanding their pathways in the medical healthcare network, it will be possible to control the patient’s treatment more accurately and thereby generating an improved treatment of patients with cholinergic urticaria.

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Organizational Data

  •   DRKS00012387
  •   2017/06/06
  •   [---]*
  •   yes
  •   Approved
  •   EA1/241/15, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   L50.5 -  Cholinergic urticaria
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Interventions/Observational Groups

  •   Step 1: Patients with cholinergic urticaria will be retrospectively assessed for their disease severity and past therapeutic interventions recorded in their patient files.
  •   Step 2: Patients with cholinergic urticaria will be assessed for their disease severity and their use of the medical health care system via online survey.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Health care system
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The aim of this project is to investigate the journey of patients suffering from cholinergic urticaria in the medical health care system in Germany.

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Secondary Outcome

Step1: retrospective assessement of disease severity and clinical characteristics and past therapeutic interventions.

Step2: detailed analysis of the use of the medical health care system of patients with different grade of disease severity, descriptive

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/05/01
  •   700
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Subproject 1: All patient records were selected from patients who visited and were treated by the allergy center within the course of urticaria consultation hours of the Charite-Universitätsmedizin Berlin due to cholinergic urticaria between December 2005 and July 2015.
Subproject 2: All adult patients suffering from cholinergic urticaria, may participate.

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Exclusion Criteria

Subproject 2: minors

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Addresses

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    • Charite-Universitätsmedizin Berlin, Klinik für Dermatologie und Allergologie
    • Ms.  Dr.  Sabine  Altrichter 
    • Chariteplatz 1
    • 10117  Berlin
    • Germany
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    • Charite-Universitätsmedizin Berlin, Klinik für Dermatologie und Allergologie
    • Ms.  Dr.  Sabine  Altrichter 
    • Chariteplatz 1
    • 10117  Berlin
    • Germany
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    • Charite-Universitätsmedizin Berlin, Klinik für Dermatologie und Allergologie
    • Ms.  Dr.  Sabine  Altrichter 
    • Chariteplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charite-Universitätsmedizin Berlin, Klinik für Dermatologie und Allergologie
    • Ms.  Dr.  Sabine  Altrichter 
    • Chariteplatz 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/08/01
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Trial Publications, Results and other Documents

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