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).”

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: interventional group
  • 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)
• No Intervention: Control group
  • only informative flyer, no further advice in any direction

Primary Measures

• Quality of life
  • Time Frame: six months
    Safety Issue?: No

Secondary Measures

• health economical effects, progress of disease, level of evidence based on diagnosis, institutionalization, hospitalization, using support possibilities, use of drugs
  • Time Frame: 6 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Ulm Other

Overall Clinical Trial Officials and Contacts

Thorsten Nikolaus, M.D., professor Principal Investigator Geriatric Center Ulm / Alb-Donau (GZU)  

Overall Contact: Albert Lukas, M.D. 1149-7311-87196 albert.lukas@bethesda-ulm.de

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00693888

Study ID Number: LTDemenz-44-052

ClinicalTrials.gov Identifier: NCT00693888

Health Authority: Germany: Ethics Commission