Trial document




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  DRKS00015686

Trial Description

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Title

Depression in the nursing home: Using a stepped collaborative care model to improve treatment

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Trial Acronym

DAVOS

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URL of the Trial

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Brief Summary in Lay Language

Study to investigate the effectiveness of a complex intervention (measure) to improve medical, psychotherapeutic and nursing care in nursing home residents.

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Brief Summary in Scientific Language

Depression in old age and the psychotherapeutic treatment of those concerned is a subject that has received relatively little attention both in research and unfortunately also from the public. At the same time, depression is the second most common psychiatric illness in elderly persons after dementia. At as much as 30%, the prevalence of depression in nursing homes is almost twice as high as in elderly people as a whole. Consequently, the DAVOS research project has implemented an innovative and structured case management program for the improvement of depression treatment in nursing home residents and is evaluating its effectiveness under everyday conditions. The main hypothesis is that the implementation of the intervention program will lead to a reduction in the prevalence of depression and a sustainable decrease in depressive symptoms among residents in the 10 participating nursing homes. Furthermore, it is expected to have positive effects on functioning ability, quality of life and social participation. The results of the project would thus provide the basis for the improved health care of nursing home residents with late-life depression in Germany.

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Organizational Data

  •   DRKS00015686
  •   2018/10/10
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  •   yes
  •   Approved
  •   129/18, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

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Health Condition or Problem studied

  •   Depression in old age
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Interventions/Observational Groups

  •   DAVOS is a controlled cluster-randomized study that employs the stepped-wedge design. This type of waiting control group design employs repeated assessments, whereby each cluster and cluster group begins in the control phase, and the intervention is gradually introduced in individual clusters after a certain delay. During the control phases, patients receive "usual care". The point at which clusters pass from the control to the intervention phase is randomized. As soon as a new cluster group passes into the intervention phase, relevant data is collected from all the clusters. In this way, data is collected throughout the duration of the intervention (T1-T4), irrespective of whether the intervention has already begun or not. Furthermore, data is collected both at baseline and during follow-up, four months before and after the intervention. Each cluster group in DAVOS includes 3-4 nursing homes in Frankfurt am Main.
  •   care-as-usual till control group becomes intervention group
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Validated questionnaires and psychometric instruments that have proven their value in clinical and gerontological research are used in the face-to-face data collection interviews. The primary outcomes of DAVOS are the prevalence of depressive disorders and the manifestation of depressive symptoms (and changes therein) in the nursing home residents (measure times Baseline, T1 to T4 and Follow-up). The primary outcomes (prevalence of depressive disorders and severity of depression symptoms) will be measured using the structured clinical interview for DSM-IV (= Diagnostic and Statistical Manual of Mental Disorders) (SCID-I) and the geriatric depression scale (GDS).

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Secondary Outcome

The secondary outcomes are quality of life, functional ability (instrumental activities of daily living), social participation and the type, frequency and duration of hospitalization during the observation period (also measure time Baseline, T1 to T4 and Follow-up). Established scales and instruments that have been specially developed for use in elderly populations such as the WHOQOL-OLD (WHO Quality of Life) questionnaire to investigate age-related dimensions of quality of life, or the Social and Emotional Loneliness questionnaire, will be used to measure secondary outcomes such as quality of life, functional ability and social participation. Information on the frequency and duration of hospitalizations will be taken from nursing home records.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2018/12/03
  •   380
  •   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

Participants in the study must be nursing home residents that are over 60 years of age and able to give their consent to take part.

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Exclusion Criteria

Exclusion criteria are an age of under 60 years, the presence of dementia, addictive disorders, bipolar disorders and other severe psychiatric diseases with the exception of depression.

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Addresses

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    • Arbeitsbereich Altersmedizin, Institut für Allgemeinmedizin der Goethe-Universität Frankfurt am Main
    • Mr.  Prof. Dr.   Johannes  Pantel 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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    • Arbeitsbereich Altersmedizin, Institut für Allgemeinmedizin der Goethe-Universität Frankfurt am Main
    • Mr.  Prof. Dr.  Johannes  Pantel 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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    • Arbeitsbereich Altersmedizin, Institut für Allgemeinmedizin der Goethe-Universität Frankfurt am Main
    • Mr.  Prof. Dr.  Johannes  Pantel 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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Sources of Monetary or Material Support

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    • DLR / BMBF im Rahmen der Forschungsprojekte zur Gesundheits- und Sozialversorgung bei Neurodegenerativen Erkrankungen im Rahmen des EU Joint Programme − Neurodegenerative Disease Research (JPND)
    • Mr.  DLR Projektträger − Gesundheit − 
    • Heinrich-Konen-Straße 1
    • 53227  Bonn
    • Germany
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Status

  •   Recruiting planned
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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.