Change in Executive Function and IADL Using a Virtual Supermarket Environment Among People With MCI (EF-VAPS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Carmel Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01103453
First received: April 7, 2010
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

The aim of the study is to investigate the feasibility of using a virtual supermarket as an intervention tool for overcoming deficits in executive function as well as enhancing IADL performance among persons with Mild Cognitive Impairment. The working hypotheses are that there will be improvement in executive functions, and the improvement in the executive functions will result in better performance in Instrumental Activities of Daily Living, both generally and especially in shopping task


Condition Intervention Phase
Mild Cognitive Impairment
Lack of Physical Activity
Behavioral: Virtual Action Planning Supermarket (VAP-S) Software
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Improvement in executive functions by means of comparison to the results on the NexAde® computerized test. [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]
    The NexAde® is a computerized assessment test for deficits in cognition and executive function. The test consists of several neuropsychological tests used in clinical practice and research and the domains being assessed are attention, memory, visuomotor learning, spatial memory, executive function and mental flexibility. The test has been adapted for older adults who are not familiar with computers and was found to be reliable and valid.


Secondary Outcome Measures:
  • Improved performance in IADL, both generally and especially in shopping task. [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]
    IADL will be examined by means of results on the MET (Multiple Errands Test) and Lawton and Brody's IADL instruments. The MET assesses executive function while performing an everyday activity by observation. It consists of three main tasks in shopping: purchase six items, find out four different pieces of information and meet the examiner at a specific time at a predetermined location. Lawton & Brawdy's IADL instrument evaluates the subject's capacity to perform eight different IADL tasks such as cooking, the use of transportation and shopping.


Estimated Enrollment: 10
Study Start Date: November 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group
Study group are persons diagnosed as suffering from Mild Cognitive Impairment will undergo a series of 9 sessions on a computer program of a virtual supermarket to improve their Executive and IADL functions.
Behavioral: Virtual Action Planning Supermarket (VAP-S) Software

The VAP-S simulates a supermarket with multiple aisles displaying items. Several obstacles are designed to hinder the progression of the shopper along the aisles. In addition, virtual humans populate the supermarket. The VAP-S is designed so that the user enters the supermarket behind the cart and navigates within the supermarket via the keyboard keys. He is thus able to experience the environment personally without any intermediate. The task is to purchase 7 items from a list, proceed to the cashier and pay for them.

We propose 9 sessions of 45 minutes. The results will be analyzed to develop goals for intervention, together with the client to study his awareness of his performance of IADL and Executive functions and to enhance his motivation to participate in the intervention.

Other Names:
  • VAP-S Virtual Action Planning - Supermarket
  • Virtools Development - Interactive 3D Development Tool
  • Discreet 3D Studio Max4 Graphics

Detailed Description:

Scientific and clinical research in the area of Alzheimer's disease (AD) during the last years have shifted their focus to earlier diagnosis and especially to the transitional phase between normal aging and dementia, named Mild Cognitive Impairment (MCI).Lately, the concept of MCI has been expanded to address observed clinical heterogeneity, and subtypes were recognized: amnestic (including memory impairment) and non-amnestic (including impairment in other non-memory cognitive domains), with the later including deficits in executive functioning Executive functions (EF) are defined as higher order functions that are needed for completing complex or non-routine tasks. Deficits in EF refer to a collection of deficits in attention, planning, problem-solving, multitasking, monitoring and behavioral control and persons who suffer from impairments in EF typically have difficulty in initiating or suspending activities, show impaired mental flexibility, as well as increased distractibility and have difficulty in learning novel tasks despite apparently intact cognitive abilities.

Lately, an increasing amount of studies suggest that persons with MCI might have deficits in EF, moreover, persons presenting a combination of executive deficits and memory deficits were found to be a high risk group for conversion to AD.

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT01103453

Contacts
Contact: Gary Sinoff, MD, PhD +972-4-8250552 GarySi@clalit.org.il

Locations
Israel
Cognitive Clinic, Carmel Medical Center Recruiting
Haifa, Israel, 34362
Contact: Gary Sinoff, MD, PhD    +972-4-8250552    GarySi@clalit.org.il   
Principal Investigator: Gary Sinoff, MD, PhD         
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Gary Sinoff, MD, PhD Carmel Medical center, Haifa, Israel
  More Information

Publications:
Responsible Party: Dr Gary Sinoff, Director Cognitive Clinic, Carmel Medical Center, Haifa, Israel
ClinicalTrials.gov Identifier: NCT01103453     History of Changes
Other Study ID Numbers: CMC090105CTIL
Study First Received: April 7, 2010
Last Updated: July 20, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Carmel Medical Center:
MCI
Executive Function
ADL
Virtual Supermarket

Additional relevant MeSH terms:
Cognition Disorders
Hypokinesia
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Dyskinesias
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014