NCT00732329CompletedNot Applicable
Effectiveness of an Optimized Home Based Occupational Therapy for Patients With Dementia.
Technische Universität Dresden3 sites in 1 country160 target enrollmentStarted: August 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 160
- Locations
- 3
- Primary Endpoint
- Alzheimer's Disease Cooperative Study/Activities of Daily Living
Study Overview
Brief Summary
The purpose of this study is to determine if a home based occupational therapy is effective in the treatment of dementia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A
Experimental
optimized home based occupational therapy including:
- diagnostic assessment
- patient-centered definition of targets involving the care giver
- occupational therapy
Intervention: Occupational Therapy (Behavioral)
B
No Intervention
treatment according to guidelines of German Society for Psychiatry, Psychotherapy and Nervous Diseases (DGPPN) and German Society of Neurology (DGN) without optimized occupational therapy
Outcomes
Primary Outcomes
Alzheimer's Disease Cooperative Study/Activities of Daily Living
Time Frame: 2 weeks, 3 and 6 months after invention or 9, 19 and 31 weeks after randomization (treatment-as-usual-group)
Secondary Outcomes
- - 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))
Investigators
Dr. Matthias Schützwohl
PD Dr.
Technische Universität Dresden
Study Sites (3)
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