Trial document





This trial has been registered retrospectively.
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  DRKS00012543

Trial Description

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Title

Validation of German Version of the "Fear-of-Falling-questionnaire" (FFQr) for detection of fear of falling in hip and pelvic fracture patients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Hip and pelvic fractures are among the most common fall related injuries in older adults. After a serious fall a lot of people develop fear of falling which can lead to activity avoidance and reduced functional recovery. Effective evaluation and identification of fear of falling allows a more specific intervention for affected patients. Therefore, the German Version of an English fear-of-falling questionnaire will be tested for validity.
This trial is a supplement of the main study being registered under DRKS00008863.

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Brief Summary in Scientific Language

This trial is a supplement of the main study being registered under DRKS00008863. For further detection of psychological dimensions of fear of falling, the English version of the Fear-of-Falling Questionnaire (FFQr, Bower and Wetherell, 2015) has already been selected for the main study and, for the first time, translated in German according to the common iterative process of translation and retranslation. For the main study, psychometric quality of the questionnaire will be evaluated for mild to moderate cognitively impaired patients after hip and pelvic fractures. In the presented supplementary trial, psychometric quality of the questionnaire will similarly be evaluated for hip and pelvic fracture patients without cognitive impairment.
The supplementary trial includes one contact for data collection during inpatient rehabilitation. All patients with a MMSE-result of more than 26 points during consecutive screening of the main study are asked for participation in the supplement trial.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012543
  •   2017/06/06
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  •   yes
  •   Approved
  •   207/2017B02, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   Hip or pelvic fracture, no cognitive impairment (MMSE 27-30)
  •   S72.0 -  Fracture of neck of femur
  •   S72.1 -  Pertrochanteric fracture
  •   S72.2 -  Subtrochanteric fracture
  •   S32.1 -  Fracture of sacrum
  •   S32.2 -  Fracture of coccyx
  •   S32.3 -  Fracture of ilium
  •   S32.4 -  Fracture of acetabulum
  •   S32.5 -  Fracture of pubis
  •   S32.7 -  Multiple fractures of lumbar spine and pelvis
  •   S32.8 -  Fracture of other and unspecified parts of lumbar spine and pelvis
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Interventions/Observational Groups

  •   Validation of the German version of the English Fear-of-Falling-Questionnaire (FFQr). One time of measurement for data collection during inpatient rehabilitation (45 minutes). Interview related to fear of falling and other aspects as well as testing of functional performance
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Characteristics

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

Validation of the German version of the original English Fear-of-Falling-Questionnaire (FFQr),
Comparison with
- the short version of the Fall related self-efficacy scale (FES-I short),
- the Montgomery-Asperg Depression Scale (MADRS),
- the Perceived Control over Falling Questionnaire (PCOF),
- the Perceived Ability to Manage Risk of Falls (PAMF)
- the Hospital Anxiety and Depression Scale (HADS), subscale anxiety,
- the Munich Personality Test (MPT), subscales extraversion and neuroticism,
- the Western Ontario and McMaster Universtities Osteoarthritis Index (WOMAC) and bodychart,
- functional performance (Short Physical Performance Battery (SPPB) and sensor-based measurement (Dynaport, McRoberts)),
Evaluation of methodological quality criteria.

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/04/13
  •   40
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

According to inclusion criteria in main study (DRKS00008863) except parameter cognitive function:

(1) No cognitive deficit (MMSE 27-30)
2) Hip or pelvic fracture within the last 3 months
(3) Community-dwelling
(4) 4 m independent walking with walking aid
(5) Age: 65 or older
(6) Vision (Snellen fraction > 20/400)

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Exclusion Criteria

According to exclusion criteria of main study (DRKS00008863):

(1) Delir
(2) severe somatic or mental disease, which does not allow participation
(3) patient is not able to understand and speak German
(4) no telephone
(5) place of domicile not reachable by public transport in the region of the study center Stuttgart or >50 km away from the study center Heidelberg
(6) moderate to severe aphasia (amnestic aphasia is not an exclusion criteria) or severe apraxia of speech
(7) terminal disease
(8) insufficient hearing ability

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Addresses

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    • Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
    • Auerbachstr. 112
    • 70376  Stuttgart
    • Germany
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    • Robert-Bosch-Krankenhaus, Klinik für Geriatrische Rehabilitation
    • Mr.  Dr.  Klaus  Pfeiffer 
    • Auerbachstr. 110
    • 70376  Stuttgart
    • Germany
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    • Robert-Bosch-Krankenhaus, Klinik für Geriatrische Rehabilitation
    • Ms.  Anja  Dautel 
    • Auerbachstr. 110
    • 70376  Stuttgart
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung
    • Kapelle-Ufer 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/11/29
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* This entry means the parameter is not applicable or has not been set.