Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00011510

Trial Description

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Title

Not-interventional health care project “RA-Express” to implement an efficient screening system for early arthritis

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Trial Acronym

RA Express

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URL of the Trial

http://www.ra-express.de/

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Brief Summary in Lay Language

Early stages of inflammatory rheumatic and musculoskeletal diseases (RMD) including rheumatoid arthritis (RA) are difficult to diagnose. For this reason, incorrect referrals to a rheumatologist result in a high use of resources in outpatient clinics.
Since more than 10 years different ways in screening patients with an early inflammatory RMDs are existing. Many different assisting diagnostic tools are used. The efficiency of various screening strategies shall be evaluated based on different disease specific key data as well as on economic key data.

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Brief Summary in Scientific Language

This project shall be realized in six different rheumatologic outpatient clinics. A total of 216 study participants with early joint symptoms shall be analyzed. The aim is to find out
- if an early arthritis can be diagnosed and
- which screening strategy leads ERA patients to an early basis therapy start.
Secondary endpoint is to evaluate if actually used diagnostic tools (patient anamnesis questionnaire, rheumachec®/ MCV-test kits and CRP-test kits) are
- suitable for an early diagnostic,
- do they increase the hit rate for diagnosis and
- do they ease the classification of the various disease symptoms in an short diagnostic time slot in the early phase.
Beside the physicians efficiency also the efficiency of rheumatologic health professional assistants, which are established meanwhile in Rheumatology, shall be evaluated.
Furthermore the use of POCT-tests and the use of the computer based documentation system (Berliner Modell) shall be analyzed not only regarding medical but also economic aspects in their impact on consultation efficiency.

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Organizational Data

  •   DRKS00011510
  •   2017/03/02
  •   [---]*
  •   yes
  •   Approved
  •   EA1/039/14, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   L93 -  Lupus erythematosus
  •   L95 -  Vasculitis limited to skin, not elsewhere classified
  •   M05 -  Seropositive rheumatoid arthritis
  •   M06 -  Other rheumatoid arthritis
  •   M07 -  Psoriatic and enteropathic arthropathies
  •   M08 -  Juvenile arthritis
  •   M13 -  Other arthritis
  •   M32 -  Systemic lupus erythematosus
  •   M35 -  Other systemic involvement of connective tissue
  •   M45 -  Ankylosing spondylitis
  •   M60 -  Myositis
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Interventions/Observational Groups

  •   Patients with joint symptoms (no longer than 12 month) get appointment after telephone screening and are seen by physician. If there is a rheumatic disease diagnosed the patient will get a new appointment otherwise there will be a follow up after 6 month by phone.
  •   Patients with joint symptoms (no longer than 12 month) fill in an online questionnaire to get an appointment. During their visit they are seen by physician. If there is a rheumatic disease diagnosed the patient will get a new appointment otherwise there will be a follow up after 6 month by phone.
  •   Patients with joint symptoms (no longer than 12 month) can visit an open consultation hour and are seen by physician. If there is a rheumatic disease diagnosed the patient will get a new appointment otherwise there will be a follow up after 6 month by phone.
  •   Patients with joint symptoms (no longer than 12 month) get appointment after telephone screening and are seen first by a rheumatologic health professional assistants and then by physician. If there is a rheumatic disease diagnosed the patient will get a new appointment otherwise there will be a follow up after 6 month by phone.
  •   Patients with joint symptoms (no longer than 12 month) fill in an online questionnaire to get an appointment. During their visit they are seen first by a rheumatologic health professional assistants and then by physician. If there is a rheumatic disease diagnosed the patient will get a new appointment otherwise there will be a follow up after 6 month by phone.
  •   Patients with joint symptoms (no longer than 12 month) can visit an open consultation hour and are seen seen first by a rheumatologic health professional assistants and then by physician. If there is a rheumatic disease diagnosed the patient will get a new appointment otherwise there will be a follow up after 6 month by phone.
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Characteristics

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

The aim of this study is to evaluate efficiency of different screening strategies in patients with early arthritis

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Secondary Outcome

Secondary endpoints
•frequency of other inflammatory rheumatic diseases with involvement of joint symptoms
•number of screened patients diagnosed by physician
•number of screened patients diagnosed by health professional assistance using structured screening path
•number of patients using
a) online questionnaire on our website
b) appointment after questioning by phone
c) consultation hour without appointment
•evaluation of the accuracy of the diagnosis with and without using POCT rheumachec®/ MCV-test kits and CRP-test kits
•comparison between supposed diagnosis and final diagnosis
•collecting duration between first contact and
a) supposed diagnosis
b) final diagnosis
c) therapy start
•collecting duration between first
a) supposed diagnosis
b) final diagnosis
c) therapy start
with and without using POCT rheumachec®/ MCV-test kits and CRP-test kits
•evaluation of process costs

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/01/15
  •   216
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Prescreening (by phone, online, consultation hours without appointment)
•Disease duration from four weeks to maximum 12 months
•At least one tender and swollen joint for more than four weeks
•No trauma or infection as cause of disorder
•No rheumatic diagnostic by other physician (e.g. family doctor, orthopaedist)
Requirement for the evaluation of the screened patients:
Signed agreement to scientific data collection, data storage and data evaluation.

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Exclusion Criteria

None

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Addresses

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    • Charité - Universitätsmedizin Berlin Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie
    • Mr.  Prof. Dr. med.  Gerd-Rüdiger  Burmester 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin BerlinKlinik mit Schwerpunkt Rheumatologie und klinische Immunologie
    • Ms.  Dr. med.  Jacqueline  Detert 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Studiengruppe InsiderCharité - Universitätsmedizin Berlin Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • AbbVie Deutschland GmbH & Co. KG
    • Max-Planck-Ring 2a
    • 65205  Wiesbaden
    • Germany
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.