Trial document




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  DRKS00013793

Trial Description

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Title

Individualized music for people with dementia - Improvement of quality of life and social participation for people with dementia in institutional care

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The increasing prevalence rate of dementia raises the question of how the quality of life and care for people with dementia can be maintained and enhanced.

Previous research shows that listening to personally meaningful music can promote positive emotions and memories as well as a reduction of stress, agitation, and anxiety of people with dementia. Thus, individualized music can be regarded as a promising, non-pharmacological intervention for people with dementia. This study investigates whether listening to individualized music improves quality of life, well-being, social participation and reduces disruptive behavior of people with dementia. It aims at evaluating the efficacy, applicability, and acceptance of an individualized music intervention for people with dementia in institutional care.

The participants will be randomly assigned to an intervention or a control group. Over a period of 6 weeks, participants of the intervention group will listen to their individualized music playlist every other day for 20 minutes. The control group participants will receive standard care. During this period, observation of behavior will be conducted for both groups every other week.
To evaluate the effects of the music intervention, nursing staff will assess the well-being, social participation, and problem behavior of the participants as well as the acceptance and applicability of the music intervention.
The results of the study are intended to contribute to the further development and improvement of care for people with dementia.

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Brief Summary in Scientific Language

First promising evidence has been provided for the effects of individualized music therapy for people with dementia. Findings indicated a reduction of agitation, depressive symptoms, and anxiety as well as a positive effect on psychosocial factors. However, there are inconsistencies and methodological limitations of these studies (e.g. lack of a clear description of the intervention, lack of an evaluation of the implementation, small sample sizes) which complicate the interpretation of the results. Thus, further research is needed.
The aim of the present study is to evaluate an individualized music intervention for people with dementia in institutional care regarding the efficacy, applicability and acceptance of the intervention. The study uses a randomized controlled pretest, posttest, follow-up design.
Six weeks before the interventions starts (T0), the severity of dementia will be assessed with the Mini-Mental State Examination. At the same time, the first external assessments by the nursing staff will be conducted regarding well-being, social participation, problem behavior, and daily behavior of the people with dementia. Between the baseline assessment (T0) and the beginning of the intervention (T1), the participants will be randomly assigned to an intervention or a control group. After randomization, the individualized playlists of the preferred music will be created for the intervention group participants in collaboration with the participants themselves (if possible), employees of the nursing home and relatives. During the six weeks of intervention, the intervention group participants listen to their individualized playlist through headphones every other day for 20 minutes. In this period of time, observation of behavior will be conducted for both groups every other week for 60 minutes.
Further external assessments will be conducted directly before the intervention starts (T1), directly after the intervention (T2), and at follow-up 6 weeks after the end of the intervention (T3). Additionally, acceptance and applicability of the music intervention will be assessed at T2.

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Organizational Data

  •   DRKS00013793
  •   2018/03/01
  •   2018/04/04
  •   yes
  •   Approved
  •   FSV 18/06, Ethikkommision der Fakultät für Sozial- und Verhaltenswissenschaften, Universität Jena
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Secondary IDs

  •   ISRCTN59052178  (ISRCTN)
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Health Condition or Problem studied

  •   F00 -  Dementia in Alzheimer disease
  •   F01 -  Vascular dementia
  •   F02 -  Dementia in other diseases classified elsewhere
  •   F03 -  Unspecified dementia
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Interventions/Observational Groups

  •   Over a period of 6 weeks, the intervention group participants will listen to their individualized music playlist through headphones every other day for 20 minutes in the presence of employees of the nursing home or project staff. Observation of behavior will be conducted by the project staff every other week before, during and after the music intervention.
  •   The control group receives standard care. The observation of behavior will be conducted with the same frequency and duration as in the intervention group.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

1. Quality of life
a) external assessment by the nursing staff at all four assessment points: mood, sleep quality, social participation (assessed with a visual analogue scale, based on Wilz & Soellner, 2015), depressive symptoms (assessed with the Cornell Scale for Depression in Dementia, CSDD)
b) Observation of behavior will be conducted three times during the intervention period using an adapted rating scale: emotional and motor changes (facial expression, body movement, other (positive) reactions), activation regarding social participation

2. Problem behavior:
a) external assessment by the nursing staff at all four assessment points: resistance to care (assessed with a visual analogue scale, based on Wilz & Soellner, 2015), problem behavior/behavioral syndromes (assessed with the Cohen-Mansfield Agitation Inventory (CMAI) and the Nurses Observation Scale for Geriatric Patients (NOSGER II)
b) Observation of behavior (see above): appearance of problem behavior or other negative reactions

Assessment points:
6 weeks before start of the intervention (T0)
beginning of the intervention (T1)
directly after the intervention (T2)
follow-up 6 weeks after the end of the intervention (T3)

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Secondary Outcome

At the second assessment point, the nursing staff will evaluate the acceptance and applicability of the intervention using a self-developed questionnaire

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2018/02/21
  •   130
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Care-dependent people with a dignosed dementia, living in a nursing home

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Exclusion Criteria

hearing problems

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Addresses

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    • Friedrich-Schiller-Universität Jena
    • Humboldstraße 11
    • 07743  Jena
    • Germany
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    • Friedrich-Schiller-Universität Jena
    • Ms.  Prof. Dr.   Gabriele  Wilz 
    • Humboldtstraße 11
    • 07743  Jena
    • Germany
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    • Friedrich-Schille-Universität Jena
    • Ms.  M. Sc.   Lisette  Weise 
    • Humboldtstraße 11
    • 07743  Jena
    • Germany
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    • Friedrich-Schiller-Universität Jena
    • Ms.  M. Sc.  Elisabeth  Jakob 
    • Humboldtstraße 11
    • 07743  Jena
    • Germany
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Sources of Monetary or Material Support

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    • GKV Spitzenverband der Pflege- und Krankenkassen
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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