Trial document





This trial has been registered retrospectively.
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  DRKS00014273

Trial Description

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Title

Daily-life function and self-reported quality of life (QoL) of geriatric patients before and after emergency treatment. Analysis of the status quo and potentials of health care improvements using the example of proximal femoral fracture

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Trial Acronym

EMAAge

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URL of the Trial

https://emanet.charite.de

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Brief Summary in Lay Language

Demographic change represents a big challenge to emergency and acute medicine: Numbers of geriatric patients in emergency departments (EDs) are increasing and will grow further during the next decades. However, data on characteristics of those patients, their health care patterns, and medium-term outcomes after their ED treatment are scarce - at least for the German situation.
EMAAge investigates ED patients presenting with hip fractures - one of the most common and typical injuries among older people. Patients will be interviewed at the bedside and six months after especially regarding their daily -life functions and their quality of life. Furthermore, administrative hospital and health insurance data will be analyzed. Health care providers' perspective (phyisicians, nurses, etc.) will be studied through qualitative interviews.

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Brief Summary in Scientific Language

EMAAge is a mixed-methods study with a prospective, multicenter cohort study at its core focusing upon the emergency and follow-up health care of multimorbid, geriatric patients and exemplarily evaluates one of the most frequent urgent health issues of this vulnerable group: the proximal femoral fracture. The project’s main aims are to characterize the patient population in terms of daily-life function, independence, and quality of life before and after admission to the emergency department, and to identify potentials for health care improvements.
Patients are consecutively recruited in the 8 Berlin-Mitte emergency departments. Primary data are collected through standardized face-to-face interviews during patients’ hospital stay, and 6 months follow-up interviews. Secondary data from Hospital Information Systems are linked to primary data.
Additionally, professional health care providers from all relevant professions and settings are interviewed qualitatively.

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Organizational Data

  •   DRKS00014273
  •   2018/05/16
  •   [---]*
  •   yes
  •   Approved
  •   EA1/362/16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   S72.0 -  Fracture of neck of femur
  •   S72.1 -  Pertrochanteric fracture
  •   S72.2 -  Subtrochanteric fracture
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Interventions/Observational Groups

  •   Patients presenting with a proximal femoral fracture in one of the participating EDs are interviewed using a questionnaire with validated instruments on quality of life (EQ-5D-5L), health status, and activities of daily living (Barthel Index); a telephone follow-up interview is carried out 6 months after;
    In addition, qualitative interviews with relevant health care providers on emergency health services for geriatric patients
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Characteristics

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

Daily-life functions: patient-reported before fracture (retrospective, t0) and follow-up 6 months after, instruments: Barthel Index, Oxford Hip Score;

Quality of life: patient-reported before fracture (retrospective, t0) and follow-up 6 months after, instrument: EQ-5D-5L

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/06/06
  •   350
  •   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

Treatment in one of the participating EDs in Berlin-Mitte due to a hip fracture

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Exclusion Criteria

no sufficient language skills in one of the provided languages

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Addresses

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    • Institut für Medizinische Soziologieund RehabilitationswissenschaftCharité - Universitätsmedizin Berlin
    • Ms.  PD Dr. phil.  Liane  Schenk 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin;Campus Charité Mitte
    • Mr.  Johannes  Deutschbein 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Campus Charité Mitte
    • Ms.  Daniela  Nagel 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • 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.