Prevention of Stroke and Dementia in Primary Care (INVADE)
This study has been terminated.
Sponsor:
Technische Universität München
Collaborators:
Allgemeine Ortskrankenkasse Bayern (AOK)
Stiftung Deutsche Schlaganfall-Hilfe
Ratiopharm
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
| Tracking Information | |||||
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| First Received Date ICMJE | April 19, 2010 | ||||
| Last Updated Date | February 16, 2012 | ||||
| Start Date ICMJE | January 2001 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01107548 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Reduction of cardiovascular risk factors [ Time Frame: 8 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prevention of Stroke and Dementia in Primary Care | ||||
| Official Title ICMJE | Intervention Project of Cerebrovascular Diseases and Dementia in the District of Ebersberg | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Systematic detection of vascular risk factors and subsequent evidence-based treatment | ||||
| Study Arm (s) | Experimental: Evidence-based treatment, lifestyle counseling
Intervention: Other: Systematic detection of vascular risk factors and subsequent evidence-based treatment |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 3908 | ||||
| Completion Date | March 2010 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 55 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01107548 | ||||
| Other Study ID Numbers ICMJE | 080250hb | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Horst Bickel, Dept. of Psychiatry, Technical University of munich | ||||
| Study Sponsor ICMJE | Technische Universität München | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Technische Universität München | ||||
| Verification Date | April 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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