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

Primary Purpose

Mild Cognitive Impairment, Lack of Physical Activity

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Virtual Action Planning Supermarket (VAP-S) Software
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring MCI, Executive Function, ADL, Virtual Supermarket

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cognitive Clinic, Carmel Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 7, 2010
Last Updated
July 20, 2011
Sponsor
Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01103453
Brief Title
Change in Executive Function and IADL Using a Virtual Supermarket Environment Among People With MCI
Acronym
EF-VAPS
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Carmel Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Lack of Physical Activity
Keywords
MCI, Executive Function, ADL, Virtual Supermarket

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Action Planning Supermarket (VAP-S) Software
Other Intervention Name(s)
VAP-S Virtual Action Planning - Supermarket, Virtools Development - Interactive 3D Development Tool, Discreet 3D Studio Max4 Graphics
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in executive functions by means of comparison to the results on the NexAde® computerized test.
Description
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.
Time Frame
1 month after intervention
Secondary Outcome Measure Information:
Title
Improved performance in IADL, both generally and especially in shopping task.
Description
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.
Time Frame
1 month after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gary Sinoff, MD, PhD
Phone
+972-4-8250552
Email
GarySi@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Sinoff, MD, PhD
Organizational Affiliation
Carmel Medical center, Haifa, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cognitive Clinic, Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Sinoff, MD, PhD
Phone
+972-4-8250552
Email
GarySi@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Gary Sinoff, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17958927
Citation
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.
Results Reference
background
PubMed Identifier
11527345
Citation
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.
Results Reference
background
PubMed Identifier
19850451
Citation
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.
Results Reference
background
PubMed Identifier
19252401
Citation
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.
Results Reference
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Change in Executive Function and IADL Using a Virtual Supermarket Environment Among People With MCI

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