Back to resultsPrevention of Stroke and Dementia in Primary Care (INVADE)
Primary Purpose
Stroke, Dementia, Disability
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Systematic detection of vascular risk factors and subsequent evidence-based treatment
Sponsored by
About this trial
This is an interventional prevention trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Age 55 years or over
- Member of a particular health insurance plan (AOK)
- Resident of the district of Ebersberg
Exclusion Criteria:
- None
Sites / Locations
- Depts. of Psychiatry and Neurology, Technische Universität München
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Evidence-based treatment, lifestyle counseling
Arm Description
Outcomes
Primary Outcome Measures
Incidence of long-term care disability
Incidence of stroke
Secondary Outcome Measures
Reduction of cardiovascular risk factors
Full Information
NCT ID
NCT01107548
First Posted
April 19, 2010
Last Updated
February 16, 2012
Sponsor
Technical University of Munich
Collaborators
AOK Bayern, Stiftung Deutsche Schlaganfall-Hilfe, Ratiopharm GmbH, Sanofi-Synthelabo, Organon, Teva Pharma GmbH, Bayer, Berlin-Chemie Menarini
1. Study Identification
Unique Protocol Identification Number
NCT01107548
Brief Title
Prevention of Stroke and Dementia in Primary Care
Acronym
INVADE
Official Title
Intervention Project of Cerebrovascular Diseases and Dementia in the District of Ebersberg
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Terminated
Study Start Date
January 2001 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Technical University of Munich
Collaborators
AOK Bayern, Stiftung Deutsche Schlaganfall-Hilfe, Ratiopharm GmbH, Sanofi-Synthelabo, Organon, Teva Pharma GmbH, Bayer, Berlin-Chemie Menarini
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In Western Countries, stroke and dementia are the main causes of long-term disability, dependency, and nursing home admission. Due to demographic trends a continuous increase of patient numbers can be expected.
There is growing evidence that vascular risk factors which are implicated in the etiology of stroke also play important etiologic roles in both vascular dementia and Alzheimer disease. The present project is aimed at the reduction of stroke and dementia by means of a systematic detection and subsequent treatment of vascular risk factors by the family doctor based on established guidelines.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Dementia, Disability
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3908 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evidence-based treatment, lifestyle counseling
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Systematic detection of vascular risk factors and subsequent evidence-based treatment
Primary Outcome Measure Information:
Title
Incidence of long-term care disability
Time Frame
8 years
Title
Incidence of stroke
Time Frame
8 Years
Secondary Outcome Measure Information:
Title
Reduction of cardiovascular risk factors
Time Frame
8 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 55 years or over
Member of a particular health insurance plan (AOK)
Resident of the district of Ebersberg
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horst Bickel, PhD
Organizational Affiliation
Dept. of Psychiatry, Technical University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depts. of Psychiatry and Neurology, Technische Universität München
City
Munich
ZIP/Postal Code
D-81675
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
12486573
Citation
Scherpinski U, Bickel H, Gnahn H, Forstl H, Conrad B, Sander D. [Intervention project on cerebrovascular diseases and dementia in the Ebersberg district (INVADE): rationale and design]. Nervenarzt. 2002 Dec;73(12):1199-204. doi: 10.1007/s00115-002-1443-8. German.
Results Reference
result
PubMed Identifier
16373634
Citation
Sander D, Schulze-Horn C, Bickel H, Gnahn H, Bartels E, Conrad B. Combined effects of hemoglobin A1c and C-reactive protein on the progression of subclinical carotid atherosclerosis: the INVADE study. Stroke. 2006 Feb;37(2):351-7. doi: 10.1161/01.STR.0000199034.26345.bc. Epub 2005 Dec 22.
Results Reference
result
PubMed Identifier
18302095
Citation
Sander K, Bickel H, Schulze Horn C, Huntgeburth U, Poppert H, Sander D. [Peripheral arterial disease: predictors and treatment intensity. Two-years of data from the population-based INVADE project]. Dtsch Med Wochenschr. 2008 Mar;133(10):455-9. doi: 10.1055/s-2008-1046731. German.
Results Reference
result
PubMed Identifier
32299118
Citation
Bickel H, Block M, Gotzler O, Hartmann J, Purner K, Sander D, Forstl H. [Prevention of stroke and dementia in general practice: evaluation of the project INVADE]. Dtsch Med Wochenschr. 2020 Jun;145(12):e61-e70. doi: 10.1055/a-1124-9124. Epub 2020 Apr 16. German.
Results Reference
derived
PubMed Identifier
23130154
Citation
Bickel H, Ander KH, Bronner M, Etgen T, Gnahn H, Gotzler O, Poppert H, Purner K, Sander D, Forstl H. Reduction of Long-Term Care Dependence After an 8-Year Primary Care Prevention Program for Stroke and Dementia: The INVADE Trial. J Am Heart Assoc. 2012 Aug;1(4):e000786. doi: 10.1161/JAHA.112.000786. Epub 2012 Aug 24.
Results Reference
derived
Links:
URL
http://www.invade.de/
Description
Related Info
Learn more about this trial
Prevention of Stroke and Dementia in Primary Care
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