NCT00693888

Brief Summary

The Geriatric Center Ulm scientifically supported a three-year pilot study (ProjektDEMENZ Ulm), in which numerous findings on the system of care regarding people suffering from dementia and their relatives were determined. One of the most important conclusions is the significant lack of information on the well-functioning network of the care system in Ulm. The full potential of the network is not being exploited. The situation in the Alb-Donau-Kreis - the area surrounding Ulm - is very similar. The investigators' aim is to improve the utilization of the system of care for those suffering from dementia in Ulm/Alb-Donau-Kreis by using a newly designed advisory approach (Lighthouse Project on Dementia, Ulm, ULTDEM study). The purpose of the study is to prove the effectiveness of this procedure by using a prospective, open, randomized, controlled, interventional study. After the randomization, the interventional group is given comprehensive, individual advice about available treatment possibilities for people suffering from dementia. In addition, they have the opportunity to re-evaluate their present diagnostic procedure. The participants of the control group receive the standard treatment. Inclusion criterion is the application of a care level ( level 0 or 1). Recruitment will take one year. A final assessment will be taken every six months.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

August 17, 2010

Status Verified

March 1, 2009

Enrollment Period

1.7 years

First QC Date

June 5, 2008

Last Update Submit

August 16, 2010

Conditions

Dementia

Keywords

dementiasystem of carelevel of careinterventional studyevaluationdementia diagnosticEvaluation of the care study

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    six months

Secondary Outcomes (1)

  • health economical effects, progress of disease, level of evidence based on diagnosis, institutionalization, hospitalization, using support possibilities, use of drugs

    6 months

Study Arms (2)

interventional group

EXPERIMENTAL

individual comprehensive primary advice (e.g. medical and social aspects, care, support at home, residential advice, legal aspects, demonstration of help and support for the relatives)

Behavioral: advice (e.g. medical and social aspects, care, support at home, residential advice, legal aspects, demonstration of help and support for the relatives)

Control group

NO INTERVENTION

only informative flyer, no further advice in any direction

Interventions

advice (e.g. medical and social aspects, care, support at home, residential advice, legal aspects, demonstration of help and support for the relatives)BEHAVIORAL

initial comprehensive assessment, stratified (city, suburbs) randomization into two groups: interventional group: individual comprehensive primary advice (medical and social aspects, care, support at home, residential advice, legal aspects, demonstration of help and support for the relatives), control group: standard support, observation over a period of 6 months, possibility of completing the diagnostic after final assessment

interventional group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • dementia (MMSE \< 24)
  • signing up for classification of care level (0 or 1)
  • community dwelling elderly (older than 60 years)
  • member of certain health insurance provider (AOK, Barmer, DAK)
  • residents of Ulm / Alb-Donau-Kreis

You may not qualify if:

  • cancer
  • consuming disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Center Ulm (GZU), Bethesda Geriatrische Klinik Ulm

Ulm, Baden-Wurttemberg, 89073, Germany

RECRUITING

MeSH Terms

Conditions

Dementia

Interventions

CounselingJurisprudencePalliative Care

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesSocial Control, FormalHealth Care Economics and OrganizationsPatient CareTherapeutics

Study Officials

  • Thorsten Nikolaus, M.D., professor

    Geriatric Center Ulm / Alb-Donau (GZU)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Albert Lukas, M.D.

CONTACT

1149-7311-87196albert.lukas@bethesda-ulm.de

Thorsten Nikolaus, M.D., professor

CONTACT

1149-7311-87185thorsten.nikolaus@bethesda-ulm.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 9, 2008

Study Start

June 1, 2008

Primary Completion

February 1, 2010

Study Completion

September 1, 2010

Last Updated

August 17, 2010

Record last verified: 2009-03

Locations

DE(1)