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

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.

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

Study Overview

• Status: Unknown
• Conditions: Mild Cognitive Impairment; Lack of Physical Activity
• Intervention / Treatment: Behavioral: Virtual Action Planning Supermarket (VAP-S) Software

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 34362
    • Recruiting
    • Cognitive Clinic, Carmel Medical Center
    • Contact: Gary Sinoff, MD, PhD; Phone Number: +972-4-8250552; Email: GarySi@clalit.org.il
    • Principal Investigator: Gary Sinoff, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in executive functions by means of comparison to the results on the NexAde® computerized test.	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.	1 month after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved performance in IADL, both generally and especially in shopping task.	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.	1 month after intervention

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Investigators: Principal Investigator: Gary Sinoff, MD, PhD, Carmel Medical Center, Haifa, Israel

Publications and helpful links

General Publications

• Belleville S. Cognitive training for persons with mild cognitive impairment. Int Psychogeriatr. 2008 Feb;20(1):57-66. doi: 10.1017/S104161020700631X. Epub 2007 Oct 25.
• Sgaramella TM, Borgo F, Mondini S, Pasini M, Toso V, Semenza C. Executive deficits appearing in the initial stage of Alzheimer's disease. Brain Cogn. 2001 Jun-Jul;46(1-2):264-8. doi: 10.1016/s0278-2626(01)80080-4.
• Josman N, Schenirderman AE, Klinger E, Shevil E. Using virtual reality to evaluate executive functioning among persons with schizophrenia: a validity study. Schizophr Res. 2009 Dec;115(2-3):270-7. doi: 10.1016/j.schres.2009.09.015. Epub 2009 Oct 22.
• Werner P, Rabinowitz S, Klinger E, Korczyn AD, Josman N. Use of the virtual action planning supermarket for the diagnosis of mild cognitive impairment: a preliminary study. Dement Geriatr Cogn Disord. 2009;27(4):301-9. doi: 10.1159/000204915. Epub 2009 Mar 2.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): November 1, 2011
• Study Completion (Anticipated): May 1, 2012

Study Registration Dates

• First Submitted: April 7, 2010
• First Submitted That Met QC Criteria: April 13, 2010
• First Posted (Estimate): April 14, 2010

Study Record Updates

• Last Update Posted (Estimate): July 21, 2011
• Last Update Submitted That Met QC Criteria: July 20, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: MCI; Executive Function; ADL; Virtual Supermarket
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurocognitive Disorders; Dyskinesias; Cognition Disorders; Cognitive Dysfunction; Hypokinesia
• Other Study ID Numbers: CMC090105CTIL