Background
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Can effects on performance be maintained 3 months post treatment?
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Does relearning of two relevant daily living tasks show any generalising effect on the patients' initiative or need for assistance in activities of daily living?
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Costs and practicability of as well as patients' satisfaction with treatment.
Methods/Design
Participants and setting
Inclusion criteria
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Persons diagnosed with Alzheimer's disease or mixed type dementia.
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Mini Mental State Examination: 14-24.
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Living at home.
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Carer available for rating the need for assistance in activities of daily living.
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At least moderate need for assistance in instrumental activities of daily living; mean score of the five household items in the performance scale of the Interview for Deterioration in Daily Living Activities in Dementia must be 2 or higher.
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Informed consent of patient and primary carer.
Exclusion criteria
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Major depression, Geriatric Depression Scale (15 items) ≥ 9.
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Major need of physical nursing care (level 2 or higher according to the German Long-Term Care Insurance Act indicated by 120 min or more per day).
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Severe behavioural disturbances, unstable medical conditions or lack of attention and understanding of simple task instructions in German language, which do not allow participation in the study as judged by the recruiting study physician.
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Involvement in other clinical trials.
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In order to achieve the recruitment of a naturalistic sample, there will be no limitation on drug therapy. During the trial duration, drug treatment should be kept as constant as it is appropriate for an optimal routine medication management. Within the statistical analysis, we will control for possible changes in anti-dementia drug treatment in both groups.
Setting
Intervention
Intervention scheme
Weeks |
0
| 1-10 |
11
|
16*
| 19-20 |
26
|
Measurement time points |
t
0
|
t
1
|
t
2
|
t
3
| ||
Intervention | 12 sessions | break | 3 refresher sessions |
Intervention sessions
Intervention adherence
Outcome
Weeks | 0 | 11 |
16*
| 19-20 | 26 | ||||
---|---|---|---|---|---|---|---|---|---|
Measurement time points | t0
| t1
|
t
2
| t3
| |||||
Intervention | 12 sessions | break | break | refresher | break | ||||
Primary outcome | |||||||||
Task Performance Scale (Rating of assessment video) | x | x |
x
| x | |||||
Secondary outcomes | |||||||||
Satisfaction with intervention (Verbal Rating Scale) | each session | each session | |||||||
Activities of daily living (Interview for Deterioration in Daily Living Activities in Dementia) | x |
x
| x | ||||||
Resource utilisation (Resource Utilisation in Dementia) | x |
x
| x | ||||||
Control measurements | |||||||||
Cognition (Mini Mental State Examination) | x | x | x | ||||||
Course of Dementia (Clinical Dementia Rating) | x | x | x | ||||||
Challenging behaviour (Neuropsychiatric Inventory, 12 items questionnaire) | x | x | x | ||||||
Socio-demographic data | x | ||||||||
Depression (Geriatric Depression Scale, 15 items) | x | ||||||||
Attention (Trail Making Test) | x | ||||||||
Intervention adherence (rating of treatment videos) | selected sessions |