Change in Executive Function and IADL Using a Virtual Supermarket Environment Among People With MCI

Phase 1

• Conditions: Mild Cognitive Impairment; Lack of Physical Activity
• Interventions: Behavioral: Virtual Action Planning Supermarket (VAP-S) Software

• Registration Number: NCT01103453
• Lead Sponsor: Carmel Medical Center

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.

Study Timeline

• Study First Submitted: 2010-04-07
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-14
• Study Start: 2010-11
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-21
• Primary Completion: 2011-11
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	Virtual Action Planning Supermarket (VAP-S) Software	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.

Primary Outcome Measures

Name	Time	Method
Improvement in executive functions by means of comparison to the results on the NexAde® computerized test.	1 month after intervention	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

Name	Time	Method
Improved performance in IADL, both generally and especially in shopping task.	1 month after intervention	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.

Trial Locations

Locations (1)

Cognitive Clinic, Carmel Medical Center; 🇮🇱 Haifa, Israel