NCT03146364

Brief Summary

This Cross-sectional Study Included Patients that diagnosed with schizophrenia, aged 18-55, 20 of which hospitalized in mental health department and 20 in medical follow-up. Different test will be administered, in two or three sessions, to evaluate cognitive ability, function ability and participation. The results of the VIS shopping task performance (statically \& dynamically) and its correlation with the cognitive and function tests as well as the participation questionnaire will be examined. These findings will indicate whether the shopping task is valid to assess executive functions for people with schizophrenia and whether it is ecologically valid.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable schizophrenia

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

April 1, 2017

Last Update Submit

May 6, 2017

Conditions

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (1)

  • Modified 4 item test

    "buy" 4 items with budget constraints, using the VIS

    through study completion, an average of 1 year

Secondary Outcomes (5)

  • Revised Observed Tasks of Daily Living (OTDL-R)

    through study completion, an average of 1 year

  • Executive Function Performance Test (EFPT)

    through study completion, an average of 1 year

  • Trail Making Test A & B (TMT)

    through study completion, an average of 1 year

  • The positive and negative syndrome scale (PANSS)

    through study completion, an average of 1 year

  • Adults Subjective Assessment of Participation

    through study completion, an average of 1 year

Study Arms (2)

Hospitalization patients

EXPERIMENTAL

patients in psychiatric hospitalization will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis)

Device: Virtual Reality - Virtual Interactive Supermarket

Ambulatory patients

EXPERIMENTAL

patients being treated in a clinic will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis)

Device: Virtual Reality - Virtual Interactive Supermarket

Interventions

SeeMe is a PC based, innovative, comprehensive, clinician-controlled exercise and diagnostic system. SeeMe is designed to aid the rehabilitation process, and track patients' progress. Virtual Interactive Supermarket- one of the SeeMe Tasks, the user need to buy products by according to specific instruction

Also known as: SeeMe
Ambulatory patientsHospitalization patients

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Schizophrenia or Scizoeffective diagnosis, Hebrew language proficiency, three weeks of anti-psychotic drug treatment

You may not qualify if:

  • score of under 70 in the 3MS (screen test), physical disability, neurological diagnosis (ex. dementia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Alon Reshef, Dr

CONTACT

Ravit Sela-Haran, OT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of psychiatry

Study Record Dates

First Submitted

April 1, 2017

First Posted

May 9, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2018

Study Completion

August 1, 2018

Last Updated

May 9, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share