NCT00732329

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 11, 2015

Status Verified

February 1, 2015

Enrollment Period

2.4 years

First QC Date

August 8, 2008

Last Update Submit

February 10, 2015

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

  • Alzheimer's Disease Cooperative Study/Activities of Daily Living

    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

    2 weeks, 3 and 6 months after invention or 9, 19 and 31 weeks after randomization (treatment-as-usual-group)

Study Arms (2)

A

EXPERIMENTAL

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

Behavioral: Occupational Therapy

B

NO INTERVENTION

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

Interventions

Occupational TherapyBEHAVIORAL

optimized home Based Occupational Therapy including: * diagnostic assessment * patient-centered definition of targets involving the care giver * occupational therapy

A

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Psychiatry and Psychotherapy

Dresden, 01307, Germany

Location

Department of Psychiatry, Psychotherapy and Psychosomatic

Günzburg, 89312, Germany

Location

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

Leipzig, 04289, Germany

Location

MeSH Terms

Conditions

Dementia

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Vjera Holthoff, Prof.

    Department of Psychiatry and Psychotherapy of University Hospital Dresden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr.

Study Record Dates

First Submitted

August 8, 2008

First Posted

August 12, 2008

Study Start

August 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 11, 2015

Record last verified: 2015-02

Locations

DE(3)