Prevention of Stroke and Dementia in Primary Care (INVADE)

This study has been terminated.
Sponsor:
Collaborators:
Allgemeine Ortskrankenkasse Bayern (AOK)
Stiftung Deutsche Schlaganfall-Hilfe
Ratiopharm GmbH
Sanofi-Synthelabo
Organon
Teva Pharma GmbH
Bayer
Berlin-Chemie Menarini
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01107548
First received: April 19, 2010
Last updated: February 16, 2012
Last verified: April 2010
  Purpose

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.


Condition Intervention
Stroke
Dementia
Disability
Other: Systematic detection of vascular risk factors and subsequent evidence-based treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Intervention Project of Cerebrovascular Diseases and Dementia in the District of Ebersberg

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Incidence of long-term care disability [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Incidence of stroke [ Time Frame: 8 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of cardiovascular risk factors [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Enrollment: 3908
Study Start Date: January 2001
Study Completion Date: March 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Evidence-based treatment, lifestyle counseling Other: Systematic detection of vascular risk factors and subsequent evidence-based treatment

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107548

Locations
Germany
Depts. of Psychiatry and Neurology, Technische Universität München
Munich, Germany, D-81675
Sponsors and Collaborators
Technische Universität München
Allgemeine Ortskrankenkasse Bayern (AOK)
Stiftung Deutsche Schlaganfall-Hilfe
Ratiopharm GmbH
Sanofi-Synthelabo
Organon
Teva Pharma GmbH
Bayer
Berlin-Chemie Menarini
Investigators
Principal Investigator: Horst Bickel, PhD Dept. of Psychiatry, Technical University of Munich
  More Information

Additional Information:
Publications:
Responsible Party: Horst Bickel, Dept. of Psychiatry, Technical University of munich
ClinicalTrials.gov Identifier: NCT01107548     History of Changes
Other Study ID Numbers: 080250hb
Study First Received: April 19, 2010
Last Updated: February 16, 2012
Health Authority: Germany: The Bavarian State Ministry of the Environment and Public Health

Additional relevant MeSH terms:
Dementia
Stroke
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014