Lighthouse Project on Dementia, Ulm, Germany (ULTDEM)
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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). |
- Quality of life [ Time Frame: six months ] [ Designated as safety issue: No ]
- 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 |
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| 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 |
| 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 | |
| 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 June 18, 2013