<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04421833</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL20_0145</org_study_id>
    <nct_id>NCT04421833</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effectiveness of the TOVERTAFEL System on Behavioral Disorders</brief_title>
  <acronym>TOVERTAFEL</acronym>
  <official_title>Evaluation of the Effectiveness of the TOVERTAFEL System on Behavioral Disorders of People With Cognitive Disorders Hospitalized in Long-Term Care Units and in Reinforced Hosting Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of behavioral disorders is high in patients living in an institutional&#xD;
      environment or hospitalized in a long-term care unit. The consequences of these symptoms are&#xD;
      not negligible with a faster cognitive decline and a significant impact on the life of the&#xD;
      institution and of other patients when the disorders are pervasive and too difficult to&#xD;
      manage for the healthcare teams.&#xD;
&#xD;
      Despite the daily attention paid to these disorders and their causes, especially the&#xD;
      environmental ones, the teams are sometimes helpless, the teams are sometimes helpless today&#xD;
      to fight against these symptoms, and their management thus constitutes a real challenge.&#xD;
&#xD;
      Non-drug interventions targeting this problem often require additional training,&#xD;
      architectural installations (Snoezelen space) and / or are moderately effective. In order to&#xD;
      offer a solution that can be used by everyone, that is transportable and based on new&#xD;
      technologies, the TOVERTAFEL device was created.&#xD;
&#xD;
      These are interactive games projected onto a table using a ceiling projector. The light&#xD;
      animations invite people to &quot;play with the light&quot; using arm or hand movements. These games&#xD;
      stimulate residents' physical activity and encourage interactions between residents and with&#xD;
      caregivers.&#xD;
&#xD;
      In this study, it is a question of evaluating the effectiveness of the TOVERTAFEL device on&#xD;
      the frequent behavioral symptoms in dementia (agitation, ambulation, apathy, anxiety), the&#xD;
      quality of life of the patients, as well as on psychotropic treatments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 10, 2020</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">August 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Behavioral and Psychological symptom dementia with Neuropsychiatric Inventory for Health Staff (NPI HS) after 6 weeks of intervention</measure>
    <time_frame>6 weeks</time_frame>
    <description>The NPI-HS makes it possible to assess out of 12 each SPCD (delusions, hallucinations, agitation, depression, anxiety, elation, apathy, disinhibition, depression, aberrant motor behavior, sleep and appetite) according to its frequency (1: sometimes, 2: quite often, 3: frequently, 4; very frequently) and according to its severity (1: mild, 2: moderate, 3: significant). The score is calculated by multiplying the frequency and severity for each dimension and adding each of these sub-scores. The maximum score is 144. Responses to the NPI-ES are collected from the healthcare team by a psychologist before the start of the intervention, then at 6 weeks and 13 weeks of inclusion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Scores obtained before and after an intervention session on the Instantaneous Well-Being Assessment scale</measure>
    <time_frame>before and after one intervention seance</time_frame>
    <description>It is a visual analog scale allowing the patient to report on his state of well-being. In response to the question &quot;How do you feel now / right now?&quot; &quot;, The patient will position their feeling of well-being by relying on pictograms representing simple facial expressions (joy, neutral and sadness) whose treatment is preserved late in the evolution of Alzheimer Disease. On the back, the positioning of the patient according to the pictograms is transcribed into a numerical value from 1 to 5. The answer &quot;1&quot; will correspond to the weakest feeling of well-being and the answer &quot;5&quot; to the feeling of the highest well-being.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score obtained from the Caregiver Apathy Inventory after 6 weeks of intervention</measure>
    <time_frame>6 weeks</time_frame>
    <description>The Caregiver Apathy Inventory collects information on the presence of apathy in patients with cerebral pathologies according to three dimensions: emotional dullness, loss of initiative, loss of interest. Each dimension is assessed by a caregiver according to its frequency (1: sometimes, 2: quite often, 3: frequently, 4; very frequently) and according to its severity (1: mild, 2: medium, 3: important). The score for each dimension is calculated by multiplying the frequency by the severity, obtaining a maximum score of 12. The total score of IA-S is obtained by adding the scores of the 3 dimensions obtaining a maximum score of 36.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the consumption of psychotropic drugs before the start of the intervention</measure>
    <time_frame>6 weeks</time_frame>
    <description>The evolution of the number of antidepressant, antipsychotic, anxiolytic and hypnotic drugs per patient will be compared according to the period (Tovertafel or usual animation techniques). For the patients concerned, the consumption of benzodiazepines translated into the administered dose equivalent to oxazepam will also be compared.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Behavioral Disorder</condition>
  <arm_group>
    <arm_group_label>group starting with TOVERTAFEL activities</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will benefit from TOVERTAFEL activities for 6 weeks then the usual animation techniques for 6 weeks with a week of wash-out between the two periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group ending with TOVERTAFEL activities</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will benefit from the usual animation techniques for 6 weeks then from TOVERTAFEL activities for 6 weeks with a week of wash-out between the two periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TOVERTAFEL</intervention_name>
    <description>The TOVERTAFEL is a small box that can be attached to the ceiling. Inside the box is a high-quality projector, infrared sensors, a speaker, and a processor that work together to project games onto the table. Because the colored objects respond to the movements of the hands and arms, the residents can play with the light itself.&#xD;
The planned activities provide cognitive, social and physical stimulation through light projections and can all be used individually or in groups with the presence of a caregiver or facilitator. Sixteen play activities are offered.</description>
    <arm_group_label>group ending with TOVERTAFEL activities</arm_group_label>
    <arm_group_label>group starting with TOVERTAFEL activities</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>USUAL activities</intervention_name>
    <description>patients can participate in cooking workshops, cinema activities (screening of old films or documentaries on a large screen, in a &quot;cozy&quot; atmosphere), walks in the garden and the visit of a dog trained in assisted therapy by the animal.</description>
    <arm_group_label>group ending with TOVERTAFEL activities</arm_group_label>
    <arm_group_label>group starting with TOVERTAFEL activities</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man or woman aged 60 to 106.&#xD;
&#xD;
          -  Patient living in one of the USLD or UHR participating in the project.&#xD;
&#xD;
          -  Score greater than or equal to 9 for at least one of the following items in the&#xD;
             NPI-ES: apathy, agitation, anxiety, depression, aberrant motor behavior.&#xD;
&#xD;
          -  Presence of TNC according to the standardization and calibration of the MMSE.&#xD;
&#xD;
          -  The patients recruited must have given themselves, or through a trusted person&#xD;
             provided for in article L. 1111-6 of the Public Health Code, failing this, by the&#xD;
             family, or, failing that, by a person having close and stable ties with the person&#xD;
             concerned; for adults under guardianship: the guardian or legal representative, for&#xD;
             adults under guardianship: the curator, their informed consent to this study which&#xD;
             must be approved by the Personal Protection Committee (PPC) prior to its completion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable pathology whose nature can interfere with the evaluation variables&#xD;
&#xD;
          -  Deafness or blindness which could compromise the patient's assessment or his&#xD;
             participation in the animation sessions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>106 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Floriane Delphin-Combe</last_name>
    <phone>472433135</phone>
    <phone_ext>+33</phone_ext>
    <email>floriane.delphin-combe@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sylvain Calvi</last_name>
    <phone>472433135</phone>
    <phone_ext>+33</phone_ext>
    <email>sylvain.calvi@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital des Charpennes</name>
      <address>
        <city>Villeurbanne</city>
        <zip>69100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Floriane Delphin-Combe</last_name>
      <phone>472433135</phone>
      <phone_ext>+33</phone_ext>
      <email>floriane.delphin-combe@chu-lyon.fr</email>
    </contact>
    <investigator>
      <last_name>Pierre KROLAK-SALMON, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 12, 2021</last_update_submitted>
  <last_update_submitted_qc>July 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dementia</keyword>
  <keyword>non-drug intervention</keyword>
  <keyword>apathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04421833
org study id: 69HCL20_0145
nct id: NCT04421833
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The prevalence of behavioral disorders is high in patients living in an institutional
      environment or hospitalized in a long-term care unit. The consequences of these symptoms are
      not negligible with a faster cognitive decline and a significant impact on the life of the
      institution and of other patients when the disorders are pervasive and too difficult to
      manage for the healthcare teams.

      Despite the daily attention paid to these disorders and their causes, especially the
      environmental ones, the teams are sometimes helpless, the teams are sometimes helpless today
      to fight against these symptoms, and their management thus constitutes a real challenge.

      Non-drug interventions targeting this problem often require additional training,
      architectural installations (Snoezelen space) and / or are moderately effective. In order to
      offer a solution that can be used by everyone, that is transportable and based on new
      technologies, the TOVERTAFEL device was created.

      These are interactive games projected onto a table using a ceiling projector. The light
      animations invite people to "play with the light" using arm or hand movements. These games
      stimulate residents' physical activity and encourage interactions between residents and with
      caregivers.

      In this study, it is a question of evaluating the effectiveness of the TOVERTAFEL device on
      the frequent behavioral symptoms in dementia (agitation, ambulation, apathy, anxiety), the
      quality of life of the patients, as well as on psychotropic treatments.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Behavioral and Psychological symptom dementia with Neuropsychiatric Inventory for Health Staff (NPI HS) after 6 weeks of intervention
time frame: 6 weeks
description: The NPI-HS makes it possible to assess out of 12 each SPCD (delusions, hallucinations, agitation, depression, anxiety, elation, apathy, disinhibition, depression, aberrant motor behavior, sleep and appetite) according to its frequency (1: sometimes, 2: quite often, 3: frequently, 4; very frequently) and according to its severity (1: mild, 2: moderate, 3: significant). The score is calculated by multiplying the frequency and severity for each dimension and adding each of these sub-scores. The maximum score is 144. Responses to the NPI-ES are collected from the healthcare team by a psychologist before the start of the intervention, then at 6 weeks and 13 weeks of inclusion.
measure: Scores obtained before and after an intervention session on the Instantaneous Well-Being Assessment scale
time frame: before and after one intervention seance
description: It is a visual analog scale allowing the patient to report on his state of well-being. In response to the question "How do you feel now / right now?" ", The patient will position their feeling of well-being by relying on pictograms representing simple facial expressions (joy, neutral and sadness) whose treatment is preserved late in the evolution of Alzheimer Disease. On the back, the positioning of the patient according to the pictograms is transcribed into a numerical value from 1 to 5. The answer "1" will correspond to the weakest feeling of well-being and the answer "5" to the feeling of the highest well-being.
measure: Score obtained from the Caregiver Apathy Inventory after 6 weeks of intervention
time frame: 6 weeks
description: The Caregiver Apathy Inventory collects information on the presence of apathy in patients with cerebral pathologies according to three dimensions: emotional dullness, loss of initiative, loss of interest. Each dimension is assessed by a caregiver according to its frequency (1: sometimes, 2: quite often, 3: frequently, 4; very frequently) and according to its severity (1: mild, 2: medium, 3: important). The score for each dimension is calculated by multiplying the frequency by the severity, obtaining a maximum score of 12. The total score of IA-S is obtained by adding the scores of the 3 dimensions obtaining a maximum score of 36.
measure: Evolution of the consumption of psychotropic drugs before the start of the intervention
time frame: 6 weeks
description: The evolution of the number of antidepressant, antipsychotic, anxiolytic and hypnotic drugs per patient will be compared according to the period (Tovertafel or usual animation techniques). For the patients concerned, the consumption of benzodiazepines translated into the administered dose equivalent to oxazepam will also be compared.
arm group label: group starting with TOVERTAFEL activities
arm group type: Active Comparator
description: Participants will benefit from TOVERTAFEL activities for 6 weeks then the usual animation techniques for 6 weeks with a week of wash-out between the two periods.
arm group label: group ending with TOVERTAFEL activities
arm group type: Sham Comparator
description: Participants will benefit from the usual animation techniques for 6 weeks then from TOVERTAFEL activities for 6 weeks with a week of wash-out between the two periods.
intervention type: Behavioral
intervention name: TOVERTAFEL
description: The TOVERTAFEL is a small box that can be attached to the ceiling. Inside the box is a high-quality projector, infrared sensors, a speaker, and a processor that work together to project games onto the table. Because the colored objects respond to the movements of the hands and arms, the residents can play with the light itself.
The planned activities provide cognitive, social and physical stimulation through light projections and can all be used individually or in groups with the presence of a caregiver or facilitator. Sixteen play activities are offered.
arm group label: group ending with TOVERTAFEL activities
arm group label: group starting with TOVERTAFEL activities
intervention type: Behavioral
intervention name: USUAL activities
description: patients can participate in cooking workshops, cinema activities (screening of old films or documentaries on a large screen, in a "cozy" atmosphere), walks in the garden and the visit of a dog trained in assisted therapy by the animal.
arm group label: group ending with TOVERTAFEL activities
arm group label: group starting with TOVERTAFEL activities
criteria: 
gender: All
minimum age: 60 Years
maximum age: 106 Years
healthy volunteers: No
last name: Floriane Delphin-Combe
phone: 472433135
phone ext: +33
email: floriane.delphin-combe@chu-lyon.fr
last name: Sylvain Calvi
phone: 472433135
phone ext: +33
email: sylvain.calvi@chu-lyon.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Mental Disorders