Effectiveness of Home Based Occupational Therapy for Dementia.

Study Overview
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Brief Summary
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The purpose of this study is to determine if a home based occupational therapy is effective in the treatment of dementia.

Official Title
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Effectiveness of an Optimized Home Based Occupational Therapy for Patients With Dementia.

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: Occupational Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dementia (according to DSM-IV TR) A score 26 to 12 on the MMSE Must be 55 or older Patient is living at home or therapeutical flat sharing Primary care giver at least 2 days / week available at home Written informed consent from patient and care giver German as dominant language Exclusion Criteria: Other dementia (p.e. frontotemporal dementia, dementia with Lewy Bodies, Creutzfeldt-Jakob disease, Parkinson's disease or atypical Parkinson's syndromes Dementia with relevant displaying behavioural problems (neuropsychiatric Inventory; NPI, Subscore ≥ 8) Depressive episodes (Geriatric Depression Scale, GDS (short version) ≥ 6) Mental disability Home Based Occupational Therapy for Dementia within the last 6 months Impairment of visual and/or acoustic cognition which does not allow Occupational Therapy Apoplexy with movement disorders which does not allow Occupational Therapy Severe physical/systemic illnesses (cardio-pulmonal, Hematological or metabolic) which do not allow participating Recent history of addictive disorder Intermittent intake of depressant medication, that likely causes an impairment of cognitive performance during the trial Participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>optimized home based occupational therapy including: diagnostic assessment patient-centered definition of targets involving the care giver occupational therapy | Behavioral: Occupational Therapy<br>* optimized home Based Occupational Therapy including: diagnostic assessment patient-centered definition of targets involving the care giver occupational therapy<br>|
| No Intervention: B<br>treatment according to guidelines of German Society for Psychiatry, Psychotherapy and Nervous Diseases (DGPPN) and German Society of Neurology (DGN) without optimized occupational therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Cooperative Study/Activities of Daily Living |  | 2 weeks, 3 and 6 months after invention or 9, 19 and 31 weeks after randomization (treatment-as-usual-group) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - for patients: cognitive performance, displaying behavioural problems, satisfaction with occupational therapy, costs of occupational therapy - for family care givers: burden, medical condition, life-satisfaction |  | 2 weeks, 3 and 6 months after invention or 9, 19 and 31 weeks after randomization (treatment-as-usual-group) |