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Completed

NCT Number: NCT00732329

Effectiveness of Home Based Occupational Therapy for Dementia.

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

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Psychotherapy, Dresden, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dementia (according to DSM-IV TR)
  • A score 26 to 12 on the MMSE
  • Must be 55 or older
  • Patient is living at home or therapeutical flat sharing
  • Primary care giver at least 2 days / week available at home
  • Written informed consent from patient and care giver
  • German as dominant language

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

Treatment and study plan

occupational therapy

Behavioral

optimized home Based Occupational Therapy including:

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

Primary outcomes

  1. 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 outcomes

  1. - 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)

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • Federal Ministry of Health, Germany

Registry information

Official study title

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

Acronym: ERGODEM

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 12, 2008
Registry last updated
Feb 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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