Trial document





This trial has been registered retrospectively.
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  DRKS00017042

Trial Description

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Title

Development of expectations and their influence on treatment response in patients with rheumatoid arthritis

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Trial Acronym

YOSO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In a previous study, we were able to show that the therapeutic response of patients with rheumatoid arthritis is influenced by their treatment expectations. It is our aim to investigate the development of treatment expectations and identify influencing factors. For this purpose, we assess expectations of patients with rheumatoid arthritis with an upcoming change in therapy by means of a self-designed questionnaire as well as questionnaires on physician-patient relationship, quality of life, previous experience with medication and adherence to therapy. Before the change in therapy and after 3 months, the disease activity is recorded and correlated with expectations and the results of the questionnaires.
In a subproject we are also investigating the influence of the autonomic nervous system on expectations and response to therapy by means of a five-minute ECG measurement and blood testing.

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Brief Summary in Scientific Language

In a previous study, we were able to show that expectations of patients with rheumatoid arthritis (RA) regarding their therapy influence their treatment response. However, little is known about the development of expectations. In this prospective study, the influence of several factors on the development of expectations and treatment response is being assessed. 150 patients with RA with an upcoming change or initiation of therapy are being included. At timepoint T0 before initiation of therapy the physician-patient relationship, quality of life, the previous experience with medication and patient adherence are being assessed. A self-designed questionnaire on expectations as well as disease activity are being recorded at T0 and after three months (T1) and correlated with the parameters assessed at T0.
In a subproject, heart rate variability (HRV) is measured by means of a five-minute ECG and the activity of the autonomous nervous system (ANS) is evaluated by determination of serological markers (including neuropeptide Y and vasoactive intestinal peptide). Changes in HRV and the activity of the ANS are being correlated with expectations and treatment response.

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Organizational Data

  •   DRKS00017042
  •   2019/03/26
  •   [---]*
  •   yes
  •   Approved
  •   6243R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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

  •   M05 -  Seropositive rheumatoid arthritis
  •   M06 -  Other rheumatoid arthritis
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Interventions/Observational Groups

  •   At timepoint T0 before change of therapy in patients with rheumatoid arthritis the following questionnaires are assessed: Questionnaire on patient expectations, questionnaire on physician-patient relationship (FAPI), adherence (Morisky score), questionnaire on previous experience with drugs (self-designed), disease activity (DAS28), health-related quality of life (SF-12 + FFbH). In addition, the attending physician is asked about his attitude towards the patient's new therapy. Also, heart rate variability is measured and a blood sample is taken to determine serological markers of the autonomous nervous system.
    3 months after the change of therapy, a reduced set of questionnaires (expectations, quality of life, disease activity, adverse effects of the new drug) is collected and the heart rate variability and serological markers are measured again.

    All therapy decisions are made independently of the study.
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Characteristics

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

Treatment response at 3 months (change in DAS28)

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Secondary Outcome

Change in heart rate variabiliy at 3 months, change in neuropeptide Y and vasoactive intestinal peptide - concentrations at 3 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/03/06
  •   150
  •   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

rheumatoid arthritis according to ACR/EULAR classifications criteria, age >18 years, sufficient German language skills

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Exclusion Criteria

insufficient German language skills, no written informed consent

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Addresses

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    • Poliklinik und Funktionsbereich für Rheumatologie und Hiller-Forschungszentrum, Universitätsklinikum Düsseldorf
    • Mr.  Prof. Dr. med.  Matthias  Schneider 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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    • Poliklinik und Funktionsbereich für Rheumatologie und Hiller-Forschungszentrum, Universitätsklinikum Düsseldorf
    • Ms.  Dr. med.  Johanna  Mucke 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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    • Poliklinik und Funktionsbereich für Rheumatologie und Hiller-Forschungszentrum, Universitätsklinikum Düsseldorf
    • Ms.  Dr. med.  Johanna  Mucke 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Poliklinik und Funktionsbereich für Rheumatologie und Hiller-Forschungszentrum, Universitätsklinikum Düsseldorf
    • Mr.  Prof. Dr. med.  Matthias  Schneider 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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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.