search
Back to results

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

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Occupational Therapy
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry and Psychotherapy
  • Department of Psychiatry, Psychotherapy and Psychosomatic
  • Department for Psychiatry, Psychosomatic und Psychotherapy (of "Park-Krankenhaus Leipzig-Südost GmbH")

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A

B

Arm Description

optimized home based occupational therapy including: diagnostic assessment patient-centered definition of targets involving the care giver occupational therapy

treatment according to guidelines of German Society for Psychiatry, Psychotherapy and Nervous Diseases (DGPPN) and German Society of Neurology (DGN) without optimized occupational therapy

Outcomes

Primary Outcome Measures

Alzheimer's Disease Cooperative Study/Activities of Daily Living

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

Full Information

First Posted
August 8, 2008
Last Updated
February 10, 2015
Sponsor
Technische Universität Dresden
Collaborators
Federal Ministry of Health, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT00732329
Brief Title
Effectiveness of Home Based Occupational Therapy for Dementia.
Acronym
ERGODEM
Official Title
Effectiveness of an Optimized Home Based Occupational Therapy for Patients With Dementia.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technische Universität Dresden
Collaborators
Federal Ministry of Health, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
optimized home based occupational therapy including: diagnostic assessment patient-centered definition of targets involving the care giver occupational therapy
Arm Title
B
Arm Type
No Intervention
Arm Description
treatment according to guidelines of German Society for Psychiatry, Psychotherapy and Nervous Diseases (DGPPN) and German Society of Neurology (DGN) without optimized occupational therapy
Intervention Type
Behavioral
Intervention Name(s)
Occupational Therapy
Intervention Description
optimized home Based Occupational Therapy including: diagnostic assessment patient-centered definition of targets involving the care giver occupational therapy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
- 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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vjera Holthoff, Prof.
Organizational Affiliation
Department of Psychiatry and Psychotherapy of University Hospital Dresden
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Department of Psychiatry, Psychotherapy and Psychosomatic
City
Günzburg
ZIP/Postal Code
89312
Country
Germany
Facility Name
Department for Psychiatry, Psychosomatic und Psychotherapy (of "Park-Krankenhaus Leipzig-Südost GmbH")
City
Leipzig
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Home Based Occupational Therapy for Dementia.

We'll reach out to this number within 24 hrs