Lighthouse Project on Dementia, Ulm, Germany

Study Overview
=================
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.

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).

Conditions
-----------------
Dementia

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


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional group<br>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)<br>* 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<br>|
| No Intervention: Control group<br>only informative flyer, no further advice in any direction | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health economical effects, progress of disease, level of evidence based on diagnosis, institutionalization, hospitalization, using support possibilities, use of drugs |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dementia, system of care, level of care, interventional study, evaluation, dementia diagnostic, Evaluation of the care study