Clinical trial NCT01107548: Prevention of Stroke and Dementia in Primary Care
Official title: Intervention Project of Cerebrovascular Diseases and Dementia in the District of Ebersberg
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Dementia
Disability
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: AOK Bayern
name: Stiftung Deutsche Schlaganfall-Hilfe
name: Ratiopharm GmbH
name: Sanofi-Synthelabo
name: Organon
name: Teva Pharma GmbH
name: Bayer
name: Berlin-Chemie Menarini
First posted: 2010-04-21
Enrollment: 3908
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incidence of long-term care disability
timeFrame: 8 years
measure: Incidence of stroke
timeFrame: 8 Years
Secondary outcomes:
measure: Reduction of cardiovascular risk factors
timeFrame: 8 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Depts. of Psychiatry and Neurology, Technische Universität München
Study officials:
affiliation: Dept. of Psychiatry, Technical University of Munich
name: Horst Bickel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.