Trial document




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  DRKS00005591

Trial Description

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Title

Psychometric properties of the De Morton Mobility Index (DEMMI) in older individuals with cognitive impairment in inpatient geriatric care

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Trial Acronym

[---]*

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URL of the Trial

http://www.hs-gesundheit.de/de/gesundheitswissenschaften/physiotherapie/forschung/mobilitaet-und-sturzrisiko-im-alter/mobilitaetsmessung-bei-demenzerkrankten/

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Brief Summary in Lay Language

The number of patients with cognitive impairment and dementia in geriatric inpatient care will increase within the next years.
A significant rehabilitation goal is an improvement of mobility, as a good level of mobility is crucial for the patient's independence and quality of life.
Established assessments are often not appropriate to measure mobility in these patients in a valid and reliable way.
The De Morton Mobility Index (DEMMI) is a mobility measure suitable for geriatric patients, that shows excellent psychometric properties, in other words, it is a valid, realiable, feasible and responsive measurement instrument.
The aim of this study is to examine the DEMMI's psychometric properties in older individuals with cognitive impairment in geriatric inpatient care.

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Brief Summary in Scientific Language

Methodological trial with examinations of validity, reliability, feasibility and responsiveness to change of a mobility measurement.

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Organizational Data

  •   DRKS00005591
  •   2015/02/04
  •   [---]*
  •   yes
  •   Approved
  •   14-110, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   Geriatric inpatients with cognitive impairment
  •   G00-G99 -  Diseases of the nervous system
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Interventions/Observational Groups

  •   To examine the DEMMI's psychometric properties, following procedures will be conducted:

    Convergent validity: All participants will be assessed with the DEMMI and other measures of mobility (Hierarchical Assessment of Balance and Mobility, Functional Ambulation Categories, Performance Oriented Mobility Assessment, gait speed, Timed Up And Go Test, 2 Minute Walk Test, Short Physical Performance Battery, Barthel Index-Mobility)

    Test-retest reliability: repetition of assessment on the same patient by the same rater within a short period of time (max. 1 day) in a sub-group of the whole sample.

    Parameters of feasibility will be: time to administer the test, occurence of adverse events (falls, vertigo, pain) during the test performance.

    Responsiveness to change: Repetition of tests prior to discharge (min. 7 days and max. 21 days after the first assessment). Additionally, assessment of a "Global Rating of Change" (GRC) based on nurse's and/or physiotherapists's jugement.

    Interpretability: floor- and ceiling effects

    Unidimensionality: Rasch analysis
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Characteristics

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

Convegent Validity: Hypothesis testing with respect to correlations between the index test (DEMMI) and other validated measures of mobility (Hierarchical Assessment of Balance and Mobility, Functional Ambulation Categories, Performance Oriented Mobility Assessment, gait speed, Timed Up And Go Test, 2 Minute Walk Test, Short Physical Performance Battery, Barthel Index-Mobility).

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Secondary Outcome

1) Test-retest reliability (level of agreement betwen 2 test results = Intra Class Coefficient [ICC]).

2) Feasibility (time to administer the DEMMI, number of adverse events).

3) Responsiveness-to-change: Hypothesis testing based on correlations between changes in the index test (DEMMI) and the reference tests. Area under the curve (AUC) with respect to a change in mobility levels (yes/no based on the "global rating of change").

4) Interpretability: floor- and ceiling-effects will be reported descriptively.

5) Unidimensionality: Rasch analysis.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/02/09
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- Acute geriatric inpatient
- Admission within the last 7 days
- Mini Mental State Examination score ≤24

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Exclusion Criteria

- contra-indication for mobilization
- Isolated due to infection
- Imminent death
- Blindness
- Deafness
- Discharged before assessment
- Non-German speaker
- In state of coma or severely reduced vigilance
- Akute severe organ failure
- Akute severe psychiatric condition
- Any other medical/physical condition where a mobility examination could worsen the medical state or where it would highly stress the participant.

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Addresses

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    • Hochschule für Gesundheit Bochum
    • Mr.  Prof. Dr.  Christian  Grüneberg 
    • Universitätsstr. 105
    • 44789  Bochum
    • Germany
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    • Hochschule für Gesundheit Bochum
    • Mr.  M.Sc.  Tobias  Braun 
    • Universitätsstr. 105
    • 44789  Bochum
    • Germany
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    • St. Marien-Hospital Köln GmbH
    • Mr.  Prof. Dr. med.  Ralf-Joachim  Schulz 
    • Kunibertskloster 11-13
    • 50668  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Hochschule für Gesundheit, Bochum
    • Mr.  Tobias  Braun 
    • Universitätsstr. 105
    • 44789  Bochum
    • Germany
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    • Lehrstuhl für Geriatrie der Universität zu Köln
    • Mr.  Tobias  Braun 
    • Kerpener-Str. 62
    • 50937  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/12/11
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Trial Publications, Results and other Documents

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