Effectiveness of Home Based Occupational Therapy for Dementia.

Dementia Clinical Trial

— ERGODEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732329
• Other study ID #: LT-DEMENZ-44-074
• Status: Completed
• Phase: N/A
• First received: August 8, 2008
• Last updated: February 10, 2015
• Start date: August 2008
• Est. completion date: January 2011

Study information

• Verified date: February 2015
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• Occupational Therapy
optimized home Based Occupational Therapy including: diagnostic assessment patient-centered definition of targets involving the care giver occupational therapy

Locations

Country	Name	City	State
Germany	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

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	Federal Ministry of Health, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	- 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)	No