We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00732329
First Posted: August 12, 2008
Last Update Posted: February 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Federal Ministry of Health, Germany
Information provided by (Responsible Party):
Dr. Matthias Schützwohl, Technische Universität Dresden
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of an Optimized Home Based Occupational Therapy for Patients With Dementia.

Resource links provided by NLM:


Further study details as provided by Dr. Matthias Schützwohl, Technische Universität Dresden:

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) ]

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) ]

Enrollment: 160
Study Start Date: August 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A

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
No Intervention: 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732329


Locations
Germany
Department of Psychiatry and Psychotherapy
Dresden, Germany, 01307
Department of Psychiatry, Psychotherapy and Psychosomatic
Günzburg, Germany, 89312
Department for Psychiatry, Psychosomatic und Psychotherapy (of "Park-Krankenhaus Leipzig-Südost GmbH")
Leipzig, Germany, 04289
Sponsors and Collaborators
Technische Universität Dresden
Federal Ministry of Health, Germany
Investigators
Study Chair: Vjera Holthoff, Prof. Department of Psychiatry and Psychotherapy of University Hospital Dresden
  More Information

Responsible Party: Dr. Matthias Schützwohl, PD Dr., Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT00732329     History of Changes
Other Study ID Numbers: LT-DEMENZ-44-074
First Submitted: August 8, 2008
First Posted: August 12, 2008
Last Update Posted: February 11, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders