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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01103453 |
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Date of registration:
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07/04/2010 |
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Primary sponsor: |
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Public title:
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Change in Executive Function and IADL Using a Virtual Supermarket Environment Among People With MCI
EF-VAPS |
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Scientific title:
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Change in Executive Functions and in Instrumental Activities of Daily Living as a Result of Intervention by Virtual Supermarket Environment Among People With Mild Cognitive Impairment. |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01103453 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Israel
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Contacts
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Name:
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Gary Sinoff, MD, PhD |
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Address:
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Telephone:
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+972-4-8250552 |
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Email:
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GarySi@clalit.org.il |
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Affiliation:
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Name:
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Gary Sinoff, MD, PhD |
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Address:
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Telephone:
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+972-4-8250552 |
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Email:
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GarySi@clalit.org.il |
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Affiliation:
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Name:
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Gary Sinoff, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Carmel Medical center, Haifa, Israel |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 60+
- Diagnosed as suffering from MCI
- No impaired judgement
- Verbal and written proficiency in Hebrew
- Normal or corrected-to-normal vision and hearing ability
- Independent in ADL function
- Lives in the community
- Able to perform task of shopping.
Exclusion Criteria:
- Suffering from other coexistent neurological diseases (e.g. stroke, muscular
dystrophy)
- Has acute arthritis
- Poorly controlled hypothyroidism
- Suffering from physical or sensory limitations, as by self-report or noted by the
investigator, that may limit the use of a computer's mouse
- No skills in performing shopping task
- Defined as suffering from depression as determined by the rating scale for depression
- Diagnosed as suffering from dementia as defined by Diagnostic and Statistical Manual
of Mental Disorders criteria (DSM-IV)
Age minimum:
60 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lack of Physical Activity
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Mild Cognitive Impairment
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Intervention(s)
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Behavioral: Virtual Action Planning Supermarket (VAP-S) Software
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Primary Outcome(s)
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Improvement in executive functions by means of comparison to the results on the NexAde® computerized test.
[Time Frame: 1 month after intervention]
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Secondary Outcome(s)
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Improved performance in IADL, both generally and especially in shopping task.
[Time Frame: 1 month after intervention]
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Secondary ID(s)
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CMC090105CTIL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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