Lighthouse Project on Dementia, Ulm, Germany (ULTDEM)
Primary Purpose
Dementia
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
advice (e.g. medical and social aspects, care, support at home, residential advice, legal aspects, demonstration of help and support for the relatives)
Sponsored by
About this trial
This is an interventional health services research trial for Dementia focused on measuring dementia, system of care, level of care, interventional study, evaluation, dementia diagnostic, Evaluation of the care study
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
Sites / Locations
- Geriatric Center Ulm (GZU), Bethesda Geriatrische Klinik UlmRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
interventional group
Control group
Arm Description
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)
only informative flyer, no further advice in any direction
Outcomes
Primary Outcome Measures
Quality of life
Secondary Outcome Measures
health economical effects, progress of disease, level of evidence based on diagnosis, institutionalization, hospitalization, using support possibilities, use of drugs
Full Information
NCT ID
NCT00693888
First Posted
June 5, 2008
Last Updated
August 16, 2010
Sponsor
University of Ulm
Collaborators
Federal Ministry of Health, Germany, Geriatric Center Ulm, Robert Bosch Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00693888
Brief Title
Lighthouse Project on Dementia, Ulm, Germany
Acronym
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).
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Ulm
Collaborators
Federal Ministry of Health, Germany, Geriatric Center Ulm, Robert Bosch Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
dementia, system of care, level of care, interventional study, evaluation, dementia diagnostic, Evaluation of the care study
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
interventional group
Arm Type
Experimental
Arm Description
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)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
only informative flyer, no further advice in any direction
Intervention Type
Behavioral
Intervention Name(s)
advice (e.g. medical and social aspects, care, support at home, residential advice, legal aspects, demonstration of help and support for the relatives)
Intervention Description
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
Primary Outcome Measure Information:
Title
Quality of life
Time Frame
six months
Secondary Outcome Measure Information:
Title
health economical effects, progress of disease, level of evidence based on diagnosis, institutionalization, hospitalization, using support possibilities, use of drugs
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Albert Lukas, M.D.
Phone
1149-7311-87196
Email
albert.lukas@bethesda-ulm.de
First Name & Middle Initial & Last Name or Official Title & Degree
Thorsten Nikolaus, M.D., professor
Phone
1149-7311-87185
Email
thorsten.nikolaus@bethesda-ulm.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thorsten Nikolaus, M.D., professor
Organizational Affiliation
Geriatric Center Ulm / Alb-Donau (GZU)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geriatric Center Ulm (GZU), Bethesda Geriatrische Klinik Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89073
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Lukas, M.D.
Phone
1149-731-187196
Email
albert.lukas@bethesda-ulm.de
First Name & Middle Initial & Last Name & Degree
Thorsten Nikolaus, M.D., professor
Phone
1149-7311-87185
Email
thorsten.nikolaus@bethesda-ulm.de
First Name & Middle Initial & Last Name & Degree
Thorsten Nikolaus, M.D., professor
12. IPD Sharing Statement
Learn more about this trial
Lighthouse Project on Dementia, Ulm, Germany
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