Trial document




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  DRKS00009619

Trial Description

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Title

Evaluation of the attitude of patients suffering from psychiatric disease and staff personal in psychiatric hospitals regarding clinical studies underlying the German Drug law.

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Trial Acronym

EPMSA

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URL of the Trial

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Brief Summary in Lay Language

Introduction:
Often, it is difficult to include patients into clinical studies underlying the Germand Drug Law (GDL). Several factors have been detected to have an impact to recruitment in studies. Looking for recruitment to psychiatric studies there is poor evidence for factors influencing recruitment.

Aim of the study:
Patients suffering from psychotic or depressive disorders as well as medical staff are included to investigate several clinical and epidemiological factor which might have an impact on the attitude to clinical studies.

Hypothesis:

1. Physicians and nurses have got a different attitude to clinical studies underlyiing the GDL.
2. Patients with depressive disorder differ in the attitude to clinical studies underlying the GDL compared with patients suffering from psychotic disorder.
3. The severity of the disease is correlated with the attitude to clinical studies underlying the GSL.

Method:
Participants to the study will be asked to fulfill a questionaire which was conducted for the study. The questionaire is composed of validated items from somatic studies and of items specific for psychiatric diseases.
Scores are correlated to different clinical and epidemiological factors. Additionally, patientgroups (psychotic vs. affective disorder, F20 and F25 vs. F32 and F33) and medical staff (physicians and nurses) are compared to each other.

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Brief Summary in Scientific Language

Introduction:
Often, it is difficult to include patients into clinical studies underlying the Germand Drug Law (GDL). Several factors have been detected to have an impact to recruitment in studies. Looking for recruitment to psychiatric studies there is poor evidence for factors influencing recruitment.

Aim of the study:
Patients suffering from psychotic or depressive disorders as well as medical staff are included to investigate several clinical and epidemiological factor which might have an impact on the attitude to clinical studies.

Hypothesis:

1. Physicians and nurses have got a different attitude to clinical studies underlyiing the GDL.
2. Patients with depressive disorder differ in the attitude to clinical studies underlying the GDL compared with patients suffering from psychotic disorder.
3. The severity of the disease is correlated with the attitude to clinical studies underlying the GDL.

Method:
One time only, participants to the study will be asked to fulfill a questionaire which was conducted for the study.The questionaire is composed of validated items from somatic studies and of items specific for psychiatric diseases.
Scores are correlated to different clinical and epidemiological factors. Additionally, patientgroups (psychotic vs. affective disorder, F20 and F25 vs. F32 and F33) and medical staff (physicians and nurses) are compared to each other.

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Organizational Data

  •   DRKS00009619
  •   2015/11/05
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  •   yes
  •   Approved
  •   2015320, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

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Health Condition or Problem studied

  •   F20 -  Schizophrenia
  •   F25 -  Schizoaffective disorders
  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   Patientgroup 1:
    Patients which are included suffer from depressive disorder (ICD10: F32.*) or recurrent depressive disorder (ICD10: F33.*).
    Age from 18 to 65 years
    Patients must stay voluntary in psychiatric hospital when included into the study.

    Aim of the study is to investigate factors which might have an impacot in recruitment to studies underlying the GML. This is of interest as in lot of psychiatric studies underlying the GML recruitment ist difficult

    One-time-only, patients are asked to fullfill a questionaire which assesses the attitude of different groups of patients suffering from psychiatric diseases. Several factors, which might have an impact on recruitment to studies underlying the GML, are analysed.

    Additionally, the severity of the psychiatric disease and the compliance is correlated to the attitude of patients.
  •   Patientgroup 2:
    Patients which are included suffer from Schizophreniar (ICD10: F20.*) or schizoaffective disorder (ICD10: F25.*).
    Age from 18 to 65 years
    Patients must stay voluntary in psychiatric hospital when included into the study.


    Aim of the study is to investigate factors which might have an impacot in recruitment to studies underlying the GML. This is of interest as in lot of psychiatric studies underlying the GML recruitment ist difficult

    One-time-only, patients are asked to fullfill a questionaire which assesses the attitude of different groups of patients suffering from psychiatric diseases. Several factors, which might have an impact on recruitment to studies underlying the GML, are analysed.

    Additionally, the severity of the psychiatric disease and the compliance is correlated to the attitude of patients.
  •   medical staff group 1:
    Medical staff personal in psychiatric hospital will be included. Staff personal must belong to the occupation group of nurses (state qualified nurse, trained nurse or nurse in training)

    In the study, we investigate the attitude of nurses in psychiatric hospital to studies underlying the GML. This is of interest, as it is difficult to win approval of patients to participate in psychiatric GML-studies. Nurses are confidential persons to psychiatric patients.
    A positive attitude of nurses to GML-studies may have an impact on recruitment of patients in GML-studies. It is of interest to understand factors which have an impact on the attitude of nurses. This can be used to gain nurses support in recruitment in GML-studies.

    One-time-only, nurses are asked to fullfill a questionaire which assesses the attitude to GML-studies. Several factors, which might have an impact on recruitment to studies underlying the GML, are analysed. Teh extracted factors are compared with the attitude of physicians in psychiatric hospitals.
  •   medical staff group 2:

    Medical staff personal in psychiatric hospital will be included. Staff personal with state examination in human medicine.

    In the study, we investigate the attitude of physicians in psychiatric hospital to studies underlying the GML. This is of interest, as it is difficult to win approval of patients to participate in psychiatric GML-studies. Physicians are confidential persons to psychiatric patients.
    A positive attitude of physicians to GML-studies may have an impact on recruitment of patients in GML-studies. It is of interest to understand factors which have an impact on the attitude of physicians. This can be used to gain physicians support in recruitment in GML-studies.

    One-time-only, physicians are asked to fullfill a questionaire which assesses the attitude to GML-studies. Several factors, which might have an impact on recruitment to studies underlying the GML, are analysed
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The staff personal groups "physicians" and "nurses" are asked to fullfill one-time-only the questionaire.

Primary endpoint:
Group comparison of the sum score in the questionaire "Attitude of sphysicians and careers to clinical studies underlying the GML".

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Secondary Outcome

Both patientgroups are asked to fullfill one-time-only the questionaires "Attitude of patients suffering from psychiatric diseases to clinical studies underlying the GML" and the "DAI-10", German version.

Hypothesis 2:
Groupcomparison of patientgroup 1 and patientgroup 2. Sumscore of the questionaire "Attitude of patients suffering from psychiatric diseases to clinical studies underlying the GML".


Hypothesis 3:
Evaluation of the sumscore of the questionaire "Attitude of patients suffering from psychiatric diseases to clinical studies underlying the GML" and sumscore of the questionaire "DAI-10", German version.
- Correlation of both sumscores in patientgroup 1.
- Correlation of both sumscores in patientgroup 2.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/01/01
  •   320
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Patientgroup 1:
actually treatment in hospital
age 18-65 years
diagnosis (ICD10): F32 and F33


Patientgroup 2:
actually treatment in hospital
age 18-65 years
diagnosis (ICD10): F20 and F25

medical staff group 1:
physicians in psychiatric hospital

medical staff group 2:
nurses in psychaitric hospital

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Exclusion Criteria

enforced stay in hospital
limited contractual capability

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Addresses

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    • LVR-Klinik Köln
    • Wilhelm-Griesinger-Str. 23
    • 51109  Köln
    • Germany
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    • LVR-Klinik Köln
    • Mr.  Dr. med.  Dirk  Reske 
    • Wilhelm-Griesinger-Str. 23
    • 51109  Köln
    • Germany
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    • LVR-Klinik Köln
    • Mr.  Dr. med.  Dirk  Reske 
    • Wilhelm-Griesinger-Str. 23
    • 51109  Köln
    • Germany
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Sources of Monetary or Material Support

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    • LVR-Klinik Köln
    • Wilhelm-Griesinger-Str. 23
    • 51109  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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