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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

August 8, 2008
December 23, 2010
August 2008
January 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00732329 on ClinicalTrials.gov Archive Site
- 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 ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Home Based Occupational Therapy for Dementia.
Effectiveness of an Optimized Home Based Occupational Therapy for Patients With Dementia.

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Dementia
Behavioral: Occupational Therapy

optimized home Based Occupational Therapy including:

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

    optimized home based occupational therapy including:

    • diagnostic assessment
    • patient-centered definition of targets involving the care giver
    • occupational therapy
    Intervention: Behavioral: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
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
Germany
 
NCT00732329
LT-DEMENZ-44-074
No
Prof. Vjera Holthoff, Department of Psychiatry and Psychotherapy of University Hospital Dresden
Technische Universität Dresden
Federal Ministry of Health, Germany
Study Chair: Vjera Holthoff, Prof. Department of Psychiatry and Psychotherapy of University Hospital Dresden
Technische Universität Dresden
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP