Trial record 3 of 75 for:    Open Studies | "Occupational Therapy"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Technische Universität Dresden.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Federal Ministry of Health, Germany
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00732329
First received: August 8, 2008
Last updated: December 23, 2010
Last verified: December 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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) ] [ 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: January 2011
Estimated 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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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 of Psychiatry, Psychotherapy and Psychosomatic Recruiting
Günzburg, Germany, 89312
Contact: Thomas Becker, Prof.    0049822196    T.Becker@bkh-guenzburg.de   
Principal Investigator: Thomas Becker, Prof.         
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.         
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

No publications provided

Responsible Party: Prof. Vjera Holthoff, Department of Psychiatry and Psychotherapy of University Hospital Dresden
ClinicalTrials.gov Identifier: NCT00732329     History of Changes
Other Study ID Numbers: LT-DEMENZ-44-074
Study First Received: August 8, 2008
Last Updated: December 23, 2010
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014