Lighthouse Project on Dementia, Ulm, Germany

Dementia Clinical Trial

— ULTDEM  

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00693888
• Other study ID #: LTDemenz-44-052
• Status: Recruiting
• Phase: N/A
• First received: June 5, 2008
• Last updated: August 16, 2010
• Start date: June 2008
• Est. completion date: September 2010

Study information

• Verified date: March 2009
• Source: University of Ulm
• Contact: Albert Lukas, M.D.
• Phone: 1149-7311-87196
• Email: albert.lukas[@]bethesda-ulm.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Dementia

Intervention

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

Locations

Country	Name	City	State
Germany	Geriatric Center Ulm (GZU), Bethesda Geriatrische Klinik Ulm	Ulm	Baden-Württemberg

Sponsors (4)

Lead Sponsor	Collaborator
University of Ulm	Federal Ministry of Health, Germany, Geriatric Center Ulm, Robert Bosch Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		six months	No
Secondary	health economical effects, progress of disease, level of evidence based on diagnosis, institutionalization, hospitalization, using support possibilities, use of drugs		6 months	No