Trial document





This trial has been registered retrospectively.
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  DRKS00007720

Trial Description

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Title

Effects of a cognitive stimulation program for people with dementia in nursing homes

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Non-pharmacological group interventions in demented patients are increasingly becoming an important approach in nursing homes. There is evidence that regular participation in cognitive stimulation programs can promote cognition, quality of life and psychological and behavior symptoms in persons with mild to moderate dementia. However, further research in this field is urgently required.

The aim of this study is to evaluate the effects of a cognitive stimulation program in persons with mild to moderate dementia residing in nursing homes. The cognitive stimulation program NEUROvitalis sinnreich was developed on the basis of actually scientific findings and consists of exercises to strengthen memory, attention and language as well as activation exercises. The program is offered in small groups with a maximum of five persons. It consists of sixteen 60-minute-sessions and will be offered two times per week over eight weeks. The planned study compares two arms of groups: the intervention group (cognitive stimulation program) and the control group (no intervention; program is offered at the end of the study). Before and after the intervention period, respectively after the 8 weeks without intervention, effects will be assessed in a neuropsychological test and in external assessments by involved nursing persons.

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Brief Summary in Scientific Language

The aim of the study is to evaluate the effects of a cognitive stimulation program in persons with mild to moderate dementia in a randomized controlled and single-blind trial. Participants will be randomly allocated to one of the two conditions: the intervention group (participation in the cognitive stimulation program) or the control group (no intervention; participation in the regular daily engagement and provisioning of the nursing home; the program will be offered at the end of the study). The program consists of sixteen 60-minute-group-sessions over eight weeks with groups of 3-5 persons. Outcome variables are cognitive functions, psychological and behavior symptoms, quality of life and activities of daily living. Before and after the intervention period, respectively after the 8 weeks without intervention, effects will be assessed in a neuropsychological test and in external assessments by involved nursing persons. Additionally, six weeks after the posttest a follow up assessment will be carried out.

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Organizational Data

  •   DRKS00007720
  •   2015/02/04
  •   [---]*
  •   yes
  •   Approved
  •   01_12, Ethikkommission der Universität Vechta
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Secondary IDs

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

  •   F00 -  Dementia in Alzheimer disease
  •   F01 -  Vascular dementia
  •   F02 -  [---]*
  •   F03 -  Unspecified dementia
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Interventions/Observational Groups

  •   Intervention group: NEUROvitalis sinnreich is a neuropsychological, cognitive stimulation program for persons with mild to moderate dementia. The program is completely structured and includes exercises to promote cognitive functions and social interaction as well as sensory perception. The program will be offered in small groups of 3-5 persons. In the study, there are two 60-minute-group-sessions per week over a period of eight weeks (in sum 16 sessions).
  •   Control group: Participants do not receive the intervention program. They participate in the regular daily engagement and provisioning of the nursing home. NEUROvitalis sinnreich will be offered at the end of the study.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Effects on cognitive functions (ADAS-Cog) and psychological and behavioural symptoms (Neuropsychiatric Inventory – Version for Nursing Homes)
The primary outcomes will be assessed at T0 (pretest), T1 (posttest after the intervention respectively after the 8 weeks without intervention) and T2 (follow-up 6 weeks after the posttest).

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Secondary Outcome

Effects on quality of life (QoL-AD and QoL-AD Proxy) and activities of daily living (ADCS-ADL Scale)
The secondary outcomes will be assessed at T0 (pretest), T1 (posttest after the intervention respectively after the 8 weeks without intervention) and T2 (follow-up 6 weeks after the posttest).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/07/14
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Persons with dementia, residing in nursing homes
Mild to moderate dementia, operationalized by the MMST: 10-25 points
German as native language or a sufficient knowledge of german language
Intact, slightly impaired or corrected eyesight and hearing ability
Persons, who are able to participate in a cognitive stimulation program
Persons, who give their written consent to participate in the study:
- by the person itself.
- if capacity for consent is limited, by a legal representative.

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Exclusion Criteria

Persons, who suffer from a life-threatening disease
Persons, with drug or alcohol abuse (at present or in the past)

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Addresses

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    • Universität Vechta, Institut für Gerontologie und Center für Neuropsychologische Diagnostik & Intervention (CeNDI)
    • Ms.  Prof. Dr.  Elke  Kalbe 
    • Driverstr. 22
    • 49377  Vechta
    • Germany
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    • Universität Vechta, Institut für Gerontologie und Center für Neuropsychologische Diagnostik & Intervention (CeNDI)
    • Ms.  Prof. Dr.  Elke  Kalbe 
    • Driverstr. 22
    • 49377  Vechta
    • Germany
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    • Universität Vechta, Institut für Gerontologie und Center für Neuropsychologische Diagnostik & Intervention (CeNDI)
    • Ms.  M.A.  Jennifer  Liesk 
    • Driverstr. 22
    • 49377  Vechta
    • Germany
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Sources of Monetary or Material Support

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    • Universität Vechta, Institut für Gerontologie und Center für Neuropsychologische Diagnostik & Intervention (CeNDI)
    • Ms.  Prof. Dr.  Elke  Kalbe 
    • Driverstr. 22
    • 49377  Vechta
    • 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.