Effectiveness of Home Based Occupational Therapy for Dementia. - Full Text View

Effectiveness of Home Based Occupational Therapy for Dementia. (ERGODEM)

This study is currently recruiting participants.

Verified by Dresden University of Technology, August 2008

First Received: August 8, 2008 Last Updated: February 26, 2009 History of Changes

Sponsors and Collaborators:	Dresden University of Technology Federal Ministry of Health, Germany
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00732329

Purpose

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

Condition	Intervention
Dementia	Behavioral: Occupational Therapy

MedlinePlus related topics: Dementia

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Effectiveness of an Optimized Home Based Occupational Therapy for Patients With Dementia.

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

- for patients: cognitive performance, displaying behavioural problems, satisfaction with occupational therapy, costs of occupational therapy - for family care givers: burden, medical condition, life-satisfaction [ Time Frame: 2 weeks, 3 and 6 months after invention or 9, 19 and 31 weeks after randomization (treatment-as-usual-group) ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	August 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental optimized home based occupational therapy including: diagnostic assessment patient-centered definition of targets involving the care giver occupational therapy	Behavioral: Occupational Therapy optimized home Based Occupational Therapy including: diagnostic assessment patient-centered definition of targets involving the care giver occupational therapy
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

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732329

Contacts

Contact: Vjera Holthoff, Prof.	+49351 458 ext 2034	vjera.holthoff@uniklinikum-dresden.de
Contact: Matthias Schützwohl, Dr.	+49351 458 ext 5490	matthias.schuetzwohl@uniklinikum-dresden.de

Locations

Germany
Department of Psychiatry and Psychotherapy	Recruiting
Dresden, Germany, 01307
Contact: Vjera Holthoff, Prof. +49 (0)351458 ext 2034 vjera.holthoff@uniklinikum-dresden.de
Principal Investigator: Vjera Holthoff, Prof.
Sub-Investigator: Matthias Schützwohl, Dr.
Sub-Investigator: Thomas Reuster, PD
Department for Psychiatry, Psychosomatic und Psychotherapy (of "Park-Krankenhaus Leipzig-Südost GmbH")	Recruiting
Leipzig, Germany, 04289
Contact: Thomas Kallert, Prof. 0049341 8 64 ext 1260 thomas.kallert@parkkrankenhaus-leipzig.de
Principal Investigator: Thomas Kallert, Prof.
Department of Psychiatry, Psychotherapy and Psychosomatic	Recruiting
Günzburg, Germany, 89312
Contact: Thomas Becker, Prof. 0049822196 T.Becker@bkh-guenzburg.de
Principal Investigator: Thomas Becker, Prof.

Sponsors and Collaborators

Dresden University of Technology

Federal Ministry of Health, Germany

Investigators

Study Chair:

Vjera Holthoff, Prof.

Department of Psychiatry and Psychotherapy of University Hospital Dresden

More Information

No publications provided

Responsible Party:	Department of Psychiatry and Psychotherapy of University Hospital Dresden ( Prof. Vjera Holthoff )
Study ID Numbers:	LT-DEMENZ-44-074
Study First Received:	August 8, 2008
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00732329 History of Changes
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Diseases
Brain Diseases

Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases

Central Nervous System Diseases
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009