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出境医 / 临床实验 / How Can a Driving Virtual Reality Tool Improve Quality of Life and Social Autonomy in Patients With Schizophrenia (Schizovirt)

How Can a Driving Virtual Reality Tool Improve Quality of Life and Social Autonomy in Patients With Schizophrenia (Schizovirt)

Study Description
Brief Summary:

Schizophrenia is a mental health issue that affects mostly young adults. The main symptoms are hallucinations, delirium, and agitation, poor social relations, lack of motivation, thought disorganization. Also, patients suffering from schizophrenia encounter important cognitive disorders affecting memory, executive functioning and attention. These cognitive alterations are often linked to social exclusion and stigmatisation.

Antipsychotic treatments are effective mainly on the positive dimension of symptoms (hallucinations etc…); however their action is very limited on the cognitive difficulties encountered. Psychosocial techniques can be used to treat the cognitive symptoms, such as cognitive remediation or psychosocial rehabilitation .

These cognitive difficulties mainly have an impact on patients' daily life, affecting their abilities to drive, for example. Schizophrenic patients suffer more road accidents than healthy subjects .

Thus, considering this information, it appears important to us to address this driving problem for various reasons:

  • Firstly, knowing how to drive is often linked to daily autonomy,
  • Secondly, driving is also linked to keeping an active social network and to work.

Patients suffering from schizophrenia often encounter difficulties in learning how to drive which reinforces the stigmatisation and fear of failure.

Thus, a specific driving and theory training prior to driving lessons could be a way of helping patients in their cognitive difficulties and pass their driving test. Daily transports mobilize a number of cognitive functions (attentional vigilance, working memory, psychomotor coordination, divided attention, visuo-spatial abilities .

Using a driving virtual reality tool could constitute an ecological cognitive remediation tool, by simulating daily driving situations. This "serious game" approach enables us to involve virtual reality in training but also in assessments. The driving simulator allows standardized evaluations and could also become a therapeutic tool of ecological cognitive remediation.

This study thus appears interesting in order to develop road safety and daily autonomy.


Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Virtual reality driving stimulation program Behavioral: TAU Not Applicable

Detailed Description:

In order to study the impact of a driving virtual reality tool on daily autonomy and cognitive functioning, patients will undertake a number of training sessions using the tool.

This study will be composed of 2 groups of schizophrenic patients.

  • the active group will benefit from 14 one hour sessions on the driving simulator. The training will be progressive and organized enabling the remediation of the different cognitive functions necessary to driving.
  • the TAU (treatment as usual) group will carry on their usual care during the length of the study. This group will help confirm the pertinence of using such a tool on a daily basis. After the end of the study, the 14 session training will be suggested to the patients who are willing.

Social autonomy, neuropsychological functioning and clinical symptomatology will be measured before, after and at a 6 month follow-up.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Importance of the Nurse's Role in Treatment Observance and Social Autonomy in Schizophrenia Using an Innovating Tool for Daily Transports: a Pilot Study
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : June 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Active group with virtual reality stimulation
The subjects in this arm will undertake 14 sessions of virtual reality stimulation. The program will be delivered by a nurse, trained to the use of such a tool, and familiar with cognitive remediation techniques. Before and after these 14 sessions, social autonomy, daily life skills, cognitive domains and self-esteem will be measured
Behavioral: Virtual reality driving stimulation program
This group will benefit of 14 one hour sessions, using the driving simulator. The program is based on a progressive training, focused on the remediation of the cognitive functions specific to driving. The tool and the type of training aim to help transfer the abilities to daily life.

Placebo Comparator: Treatment as Usual group (TAU)
Patients in this group will carry on benefiting from their usual care with no additional program. They will be assessed before and after a 3 month period for social autonomy, daily life skills, cognitive domains and self-esteem.
Behavioral: TAU
This group will carry on their usual treatment during the whole length of the study. Patients will be randomized into the 2 groups. This TAU group will be the control group and will help assess the effectiveness of the stimulation program. The stimulation sessions will be proposed to the TAU group at the end of study.

Outcome Measures
Primary Outcome Measures :
  1. Social Autonomy [ Time Frame: 7 months ]
    the primary outcome will be the modification before and after intervention of the total score on the Social Autonomy scale. It is obtained by 5 domains (personal health, everyday life, money, social relationships, and affective life).


Secondary Outcome Measures :
  1. Rosenberg Self-esteem [ Time Frame: 7 months ]
    the outcome measure of self esteem will be the modification before and after the score of scale. It is a brief auto-questionnaire.

  2. World Health Organization Quality of Life Assessment (WHOQLOL-BREF) [ Time Frame: 7 months ]
    the quality of life will be evaluated before and after intervention

  3. The positive and negative syndrome (PANSS) [ Time Frame: 7 months ]
    the measure of cognitive functioning specific to the driving situation will be the modification before and after intervention of the score obtained at the proposed neuropsychological evaluation (executive, attentional and social)

  4. Car Simulator Evaluation Test [ Time Frame: 7 months ]

    Change in score "Car Simulator Evaluation Test" . This measure is repeated at the beginning and at the end of the intervention to highlight the impact of the " Car Simulator " program, and 6 months later to investigate the benefits.

    the impact of the program on road safety knowledge outcome will be assessed by the modification before and after of scores using the assessments available with the driving tool



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnostic of Schizophrenia according to a DSM-5 criteria
  • Aged between 18-50 years
  • Enrolled in an empowerment project
  • Stable clinical status, without treatment modification for 3 months
  • Capacity to consent
  • Affiliated to a social security scheme

Exclusion Criteria:

  • Opposition of patient or legal guardian
  • Background of head trauma, neurological pathology with cerebral repercussions or severe somatic or ocular disease not stabilized or resulting in pain> 3 months
  • Visual disorders related to surgery or known ocular pathology leading to visual loss or visual field restriction
  • Mental retardation < 80
  • Simultaneous participation in another cognitive remediation program (6-month exclusion period)
  • Simultaneous participation in another study involving cognitive processes (6-month exclusion period)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: ROMAIN REY, PH +33(0)437915280 Romain.Rey@ch-le-vinatier.fr
Contact: VERONIQUE VIAL +33(0)437915531 Veronique.Vial@ch-le-vinatier.fr

Locations
Layout table for location information
France
Hôpital le vinatier Recruiting
Bron, France, 69677
Contact: thierry d'Amato, MD, PhD    +33437915565      
Hopital Vinatier Not yet recruiting
Bron, France, 69678
Contact: ROMAIN REY, PH    +33(0)437915280    Romain.Rey@ch-le-vinatier.fr   
Contact: VERONIQUE VIAL    +33(0)437915531    Veronique.Vial@ch-le-vinatier.fr   
Sponsors and Collaborators
Hôpital le Vinatier
Investigators
Layout table for investigator information
Principal Investigator: ROMAIN REY, PH CH Le Vinatier
Tracking Information
First Submitted Date  ICMJE April 25, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE June 25, 2019
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
Social Autonomy [ Time Frame: 7 months ]
the primary outcome will be the modification before and after intervention of the total score on the Social Autonomy scale. It is obtained by 5 domains (personal health, everyday life, money, social relationships, and affective life).
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
Social Autonomy scale [ Time Frame: 7 months ]
the primary outcome will be the modification before and after intervention of the total score on the Social Autonomy scale. It is obtained by 5 domains (personal health, everyday life, money, social relationships, and affective life).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • Rosenberg Self-esteem [ Time Frame: 7 months ]
    the outcome measure of self esteem will be the modification before and after the score of scale. It is a brief auto-questionnaire.
  • World Health Organization Quality of Life Assessment (WHOQLOL-BREF) [ Time Frame: 7 months ]
    the quality of life will be evaluated before and after intervention
  • The positive and negative syndrome (PANSS) [ Time Frame: 7 months ]
    the measure of cognitive functioning specific to the driving situation will be the modification before and after intervention of the score obtained at the proposed neuropsychological evaluation (executive, attentional and social)
  • Car Simulator Evaluation Test [ Time Frame: 7 months ]
    Change in score "Car Simulator Evaluation Test" . This measure is repeated at the beginning and at the end of the intervention to highlight the impact of the " Car Simulator " program, and 6 months later to investigate the benefits. the impact of the program on road safety knowledge outcome will be assessed by the modification before and after of scores using the assessments available with the driving tool
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • Rosenberg Self-esteem scale [ Time Frame: 7 months ]
    the outcome measure of self esteem will be the modification before and after the score of scale. It is a brief auto-questionnaire.
  • World Health Organization Quality of Life Assessment (WHOQLOL-BREF) [ Time Frame: 7 months ]
    the quality of life will be evaluated before and after intervention
  • The positive and negative syndrome scale (PANSS) [ Time Frame: 7 months ]
    the measure of cognitive functioning specific to the driving situation will be the modification before and after intervention of the score obtained at the proposed neuropsychological evaluation (executive, attentional and social)
  • Car Simulator Evaluation Test [ Time Frame: 7 months ]
    Change in score "Car Simulator Evaluation Test" . This measure is repeated at the beginning and at the end of the intervention to highlight the impact of the " Car Simulator " program, and 6 months later to investigate the benefits. the impact of the program on road safety knowledge outcome will be assessed by the modification before and after of scores using the assessments available with the driving tool
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE How Can a Driving Virtual Reality Tool Improve Quality of Life and Social Autonomy in Patients With Schizophrenia
Official Title  ICMJE The Importance of the Nurse's Role in Treatment Observance and Social Autonomy in Schizophrenia Using an Innovating Tool for Daily Transports: a Pilot Study
Brief Summary

Schizophrenia is a mental health issue that affects mostly young adults. The main symptoms are hallucinations, delirium, and agitation, poor social relations, lack of motivation, thought disorganization. Also, patients suffering from schizophrenia encounter important cognitive disorders affecting memory, executive functioning and attention. These cognitive alterations are often linked to social exclusion and stigmatisation.

Antipsychotic treatments are effective mainly on the positive dimension of symptoms (hallucinations etc…); however their action is very limited on the cognitive difficulties encountered. Psychosocial techniques can be used to treat the cognitive symptoms, such as cognitive remediation or psychosocial rehabilitation .

These cognitive difficulties mainly have an impact on patients' daily life, affecting their abilities to drive, for example. Schizophrenic patients suffer more road accidents than healthy subjects .

Thus, considering this information, it appears important to us to address this driving problem for various reasons:

  • Firstly, knowing how to drive is often linked to daily autonomy,
  • Secondly, driving is also linked to keeping an active social network and to work.

Patients suffering from schizophrenia often encounter difficulties in learning how to drive which reinforces the stigmatisation and fear of failure.

Thus, a specific driving and theory training prior to driving lessons could be a way of helping patients in their cognitive difficulties and pass their driving test. Daily transports mobilize a number of cognitive functions (attentional vigilance, working memory, psychomotor coordination, divided attention, visuo-spatial abilities .

Using a driving virtual reality tool could constitute an ecological cognitive remediation tool, by simulating daily driving situations. This "serious game" approach enables us to involve virtual reality in training but also in assessments. The driving simulator allows standardized evaluations and could also become a therapeutic tool of ecological cognitive remediation.

This study thus appears interesting in order to develop road safety and daily autonomy.

Detailed Description

In order to study the impact of a driving virtual reality tool on daily autonomy and cognitive functioning, patients will undertake a number of training sessions using the tool.

This study will be composed of 2 groups of schizophrenic patients.

  • the active group will benefit from 14 one hour sessions on the driving simulator. The training will be progressive and organized enabling the remediation of the different cognitive functions necessary to driving.
  • the TAU (treatment as usual) group will carry on their usual care during the length of the study. This group will help confirm the pertinence of using such a tool on a daily basis. After the end of the study, the 14 session training will be suggested to the patients who are willing.

Social autonomy, neuropsychological functioning and clinical symptomatology will be measured before, after and at a 6 month follow-up.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Behavioral: Virtual reality driving stimulation program
    This group will benefit of 14 one hour sessions, using the driving simulator. The program is based on a progressive training, focused on the remediation of the cognitive functions specific to driving. The tool and the type of training aim to help transfer the abilities to daily life.
  • Behavioral: TAU
    This group will carry on their usual treatment during the whole length of the study. Patients will be randomized into the 2 groups. This TAU group will be the control group and will help assess the effectiveness of the stimulation program. The stimulation sessions will be proposed to the TAU group at the end of study.
Study Arms  ICMJE
  • Experimental: Active group with virtual reality stimulation
    The subjects in this arm will undertake 14 sessions of virtual reality stimulation. The program will be delivered by a nurse, trained to the use of such a tool, and familiar with cognitive remediation techniques. Before and after these 14 sessions, social autonomy, daily life skills, cognitive domains and self-esteem will be measured
    Intervention: Behavioral: Virtual reality driving stimulation program
  • Placebo Comparator: Treatment as Usual group (TAU)
    Patients in this group will carry on benefiting from their usual care with no additional program. They will be assessed before and after a 3 month period for social autonomy, daily life skills, cognitive domains and self-esteem.
    Intervention: Behavioral: TAU
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnostic of Schizophrenia according to a DSM-5 criteria
  • Aged between 18-50 years
  • Enrolled in an empowerment project
  • Stable clinical status, without treatment modification for 3 months
  • Capacity to consent
  • Affiliated to a social security scheme

Exclusion Criteria:

  • Opposition of patient or legal guardian
  • Background of head trauma, neurological pathology with cerebral repercussions or severe somatic or ocular disease not stabilized or resulting in pain> 3 months
  • Visual disorders related to surgery or known ocular pathology leading to visual loss or visual field restriction
  • Mental retardation < 80
  • Simultaneous participation in another cognitive remediation program (6-month exclusion period)
  • Simultaneous participation in another study involving cognitive processes (6-month exclusion period)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ROMAIN REY, PH +33(0)437915280 Romain.Rey@ch-le-vinatier.fr
Contact: VERONIQUE VIAL +33(0)437915531 Veronique.Vial@ch-le-vinatier.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03973853
Other Study ID Numbers  ICMJE 2018-A02799-46
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hôpital le Vinatier
Study Sponsor  ICMJE Hôpital le Vinatier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ROMAIN REY, PH CH Le Vinatier
PRS Account Hôpital le Vinatier
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP