Effectiveness of Home Based Occupational Therapy for Dementia.

NCT ID: NCT00732329

Last Updated: 2015-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-01-31

Brief Summary

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

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

optimized home based occupational therapy including:

• diagnostic assessment
• patient-centered definition of targets involving the care giver
• occupational therapy

Group Type: EXPERIMENTAL

Occupational Therapy

Intervention Type: BEHAVIORAL

optimized home Based Occupational Therapy including:

• diagnostic assessment
• patient-centered definition of targets involving the care giver
• occupational therapy

B

treatment according to guidelines of German Society for Psychiatry, Psychotherapy and Nervous Diseases (DGPPN) and German Society of Neurology (DGN) without optimized occupational therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Occupational Therapy

optimized home Based Occupational Therapy including:

• diagnostic assessment
• patient-centered definition of targets involving the care giver
• occupational therapy

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Dementia (according to DSM-IV TR)

2. A score 26 to 12 on the MMSE

3. Must be 55 or older

4. Patient is living at home or therapeutical flat sharing

5. Primary care giver at least 2 days / week available at home

6. Written informed consent from patient and care giver

7. German as dominant language

Exclusion Criteria

1. Other dementia (p.e. frontotemporal dementia, dementia with Lewy Bodies, Creutzfeldt-Jakob disease, Parkinson's disease or atypical Parkinson's syndromes

2. Dementia with relevant displaying behavioural problems (neuropsychiatric Inventory; NPI, Subscore ≥ 8)

3. Depressive episodes (Geriatric Depression Scale, GDS (short version) ≥ 6)

4. Mental disability

5. Home Based Occupational Therapy for Dementia within the last 6 months

6. Impairment of visual and/or acoustic cognition which does not allow Occupational Therapy

7. Apoplexy with movement disorders which does not allow Occupational Therapy

8. Severe physical/systemic illnesses (cardio-pulmonal, Hematological or metabolic) which do not allow participating

9. Recent history of addictive disorder

10. Intermittent intake of depressant medication, that likely causes an impairment of cognitive performance during the trial

11. Participation in another clinical trial

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal Ministry of Health, Germany

OTHER_GOV

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Dr. Matthias Schützwohl

PD Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vjera Holthoff, Prof.

Role: STUDY_CHAIR

Department of Psychiatry and Psychotherapy of University Hospital Dresden

Locations

Department of Psychiatry and Psychotherapy

Dresden, , Germany

Department of Psychiatry, Psychotherapy and Psychosomatic

Günzburg, , Germany

Department for Psychiatry, Psychosomatic und Psychotherapy (of "Park-Krankenhaus Leipzig-Südost GmbH")

Leipzig, , Germany

Countries

Germany

Other Identifiers

LT-DEMENZ-44-074

Identifier Type: -

Identifier Source: org_study_id