NCT01107548

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,908

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
Last Updated

February 20, 2012

Status Verified

April 1, 2010

Enrollment Period

7.9 years

First QC Date

April 19, 2010

Last Update Submit

February 16, 2012

Conditions

StrokeDementiaDisability

Outcome Measures

Primary Outcomes (2)

  • Incidence of long-term care disability

    8 years

  • Incidence of stroke

    8 Years

Secondary Outcomes (1)

  • Reduction of cardiovascular risk factors

    8 years

Study Arms (1)

Evidence-based treatment, lifestyle counseling

EXPERIMENTAL
Other: Systematic detection of vascular risk factors and subsequent evidence-based treatment

Interventions

Systematic detection of vascular risk factors and subsequent evidence-based treatmentOTHER
Evidence-based treatment, lifestyle counseling

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 55 years or over
  • Member of a particular health insurance plan (AOK)
  • Resident of the district of Ebersberg

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Depts. of Psychiatry and Neurology, Technische Universität München

Munich, D-81675, Germany

Location

Related Publications (5)

  • 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.

    PMID: 12486573RESULT

  • 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.

    PMID: 16373634RESULT

  • 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.

    PMID: 18302095RESULT

  • 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.

    PMID: 32299118DERIVED

  • 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.

    PMID: 23130154DERIVED

Related Links

MeSH Terms

Conditions

StrokeDementia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Horst Bickel, PhD

    Dept. of Psychiatry, Technical University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 21, 2010

Study Start

January 1, 2001

Primary Completion

December 1, 2008

Study Completion

March 1, 2010

Last Updated

February 20, 2012

Record last verified: 2010-04

Locations

DE(1)