Clinical trial NCT00693888: Lighthouse Project on Dementia, Ulm, Germany
Official title: Lighthouse Project on Dementia, Ulm, Germany - Improvement of Advice and Diagnostics for People Suffering From Dementia After the Classification of Their Level of Care (ULTDEM Study).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Keywords: dementia
system of care
level of care
interventional study
evaluation
dementia diagnostic
Evaluation of the care study
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: Federal Ministry of Health, Germany
name: Geriatric Center Ulm
name: Robert Bosch Medical Center
First posted: 2008-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* result from the inclusion criteria
* cancer
* consuming disease

Primary outcomes:
measure: Quality of life
timeFrame: six months
Secondary outcomes:
measure: health economical effects, progress of disease, level of evidence based on diagnosis, institutionalization, hospitalization, using support possibilities, use of drugs
timeFrame: 6 months
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Geriatric Center Ulm (GZU), Bethesda Geriatrische Klinik Ulm
state: Baden-Württemberg
Study officials:
affiliation: Geriatric Center Ulm / Alb-Donau (GZU)
name: Thorsten Nikolaus, M.D., professor
role: PRINCIPAL_INVESTIGATOR
References: