Lighthouse Project on Dementia, Ulm, Germany (ULTDEM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University of Ulm.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Federal Ministry of Health, Germany
Geriatric Center Ulm
Robert Bosch Medical Center
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00693888
First received: June 5, 2008
Last updated: August 16, 2010
Last verified: March 2009
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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).

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Quality of life [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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
No Intervention: Control group
only informative flyer, no further advice in any direction

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693888

Contacts
Contact: Albert Lukas, M.D. 1149-7311-87196 albert.lukas@bethesda-ulm.de
Contact: Thorsten Nikolaus, M.D., professor 1149-7311-87185 thorsten.nikolaus@bethesda-ulm.de

Locations
Germany
Geriatric Center Ulm (GZU), Bethesda Geriatrische Klinik Ulm Recruiting
Ulm, Baden-Württemberg, Germany, 89073
Contact: Albert Lukas, M.D.    1149-731-187196    albert.lukas@bethesda-ulm.de   
Contact: Thorsten Nikolaus, M.D., professor    1149-7311-87185    thorsten.nikolaus@bethesda-ulm.de   
Principal Investigator: Thorsten Nikolaus, M.D., professor         
Sponsors and Collaborators
University of Ulm
Federal Ministry of Health, Germany
Geriatric Center Ulm
Robert Bosch Medical Center
Investigators
Principal Investigator: Thorsten Nikolaus, M.D., professor Geriatric Center Ulm / Alb-Donau (GZU)
  More Information

No publications provided

Responsible Party: Thorsten Nikolaus, M.D. professor, Geriatric Center Ulm (GZU)
ClinicalTrials.gov Identifier: NCT00693888     History of Changes
Other Study ID Numbers: LTDemenz-44-052
Study First Received: June 5, 2008
Last Updated: August 16, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University of Ulm:
dementia
system of care
level of care
interventional study
evaluation
dementia diagnostic
Evaluation of the care study

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014