xml: <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/NCT05966623</url>
    </required_header>
    <id_info>
      <org_study_id>-2021-05-50-M1</org_study_id>
      <nct_id>NCT05966623</nct_id>
    </id_info>
    <brief_title>Assessing the Impact of Vidéo Remote Sign Language Interpreting in Healthcare</brief_title>
    <acronym>Impact of VRI</acronym>
    <official_title>Assessing the Impact of Vidéo Remote Sign Language Interpreting in Healthcare: Linking Disability Studies With Empirical Challenges of Public Health Research</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Geneva, Switzerland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Universidad del Rosario</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hospital Universitario Mayor Mederi</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Clinica Nuestra Senora de la Paz</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Geneva, Switzerland</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a randomise study that looks at what is the effectiveness of the VRI system in&#xD;
        improving communication outcomes between Deaf patients and doctors versus the 'available&#xD;
        standard of care of the usual communication tools, including informal interpretation, lip or&#xD;
        note reading, using their mobile phones to contact a formal or informal interpreter, for Deaf&#xD;
        patients aged 18 and older in Bogota Colombia&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background and Rationale:&#xD;
  &#xD;
        In-person or VRI sign language interpretation is largely unavailable. In a scoping review,&#xD;
        the researchers identified a knowledge gap regarding the quality of interpretation and&#xD;
        training in sign language interpretation for health care. The researchers also found that&#xD;
        this area is under-researched, and the evidence is scant. All available evidence came from&#xD;
        high-income countries, which is particularly problematic given that most DHH persons live in&#xD;
        low- and middle-income countries. Thus, the available literature shows that VRI may enable&#xD;
        deaf users to overcome interpretation barriers and can potentially improve communication&#xD;
        outcomes between them and health personnel within health care services. For VRI to be&#xD;
        acceptable, sign language users require a VRI system supported by devices with large screens&#xD;
        and a reliable internet connection, as well as qualified interpreters trained in medical&#xD;
        interpretation. There is no clear data on the availability of VRI or in-person&#xD;
        interpretation. Given the cost, VRI may be more available than in person. Available data tend&#xD;
        to focus on assessing personal references of Deaf users in regards to interpretation, as well&#xD;
        as interpreters' preferences and maximising recourses allocation.&#xD;
  &#xD;
        Objective(S):&#xD;
  &#xD;
        To assess the effectiveness of the VRI system in improving communication outcomes between&#xD;
        Deaf patients and doctors Produce a VRI model addressing the challenges faced by Deaf people&#xD;
        that will be tested, implemented, and sustained in Bogota, Colombia.&#xD;
  &#xD;
        Explanation for choice of comparator&#xD;
  &#xD;
        In-person or VRI sign language interpretation is largely unavailable. Thus, there is no clear&#xD;
        data on the magnitude of the availability gap of VRI or in-person interpretation. In-person&#xD;
        qualified sign language interpretation in the healthcare setting tends to be described as the&#xD;
        ideal standard of service provision. Thus, it is largely unavailable even in HIC. The&#xD;
        assumption is based upon minimal available evidence on the personal preferences of Deaf&#xD;
        persons in the USA. There is no evidence that in-person interpretation is efficient in the&#xD;
        context of weaker infrastructure, such as low sign language literacy rates across Deaf&#xD;
        persons, lack of standard qualification of interpreters and lack of interpreters and&#xD;
        sustainable financing in HIC. To my knowledge, there is no study assessing DPC while using&#xD;
        sign language interpretation.&#xD;
  &#xD;
        Given the cost, VRI may be more sustainable than in-person. Assessing the efficiency of VRI&#xD;
        versus the standard of care would be d of more value, given that there is no other effective&#xD;
        intervention to compare.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 14, 2023</start_date>
    <completion_date type="Anticipated">July 14, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 14, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Arm Intervention Experimental VRI sign language interpretation Participants will be welcome from their entry point to the hospital, they will attend a general check-up with a GP or other services and be provided with VRI until they leave Participants will be provided with a Tablet of 14' inches with interrupted VRI in Colombian Sign Language. Professionally accredited Sign language interpreter. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-Communication&#xD;
  Experimental: primo control Participants get welcome at the entry point of the hospital, they will attend a general check-up with a GP or other services and they are not provided with by the study with VRI Participants get welcome at the entry point of the hospital, they are not provided with VRI. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-communication</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Single-blinded - The researcher needs to learn before the patient comes to the hospital as VRI needs to be organised. Thus, they will only know if the participants shall be assigned to the intervention or control group after the patient agrees to take part. Double blinding is not feasible as interpreters will not be available 24x7.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Communication outcomes</measure>
      <time_frame>12 months</time_frame>
      <description>The score of a selected' scale assesses A: creating a good interpersonal relationship, B: exchanging information, and C: Making treatment-related decisions that involve the patients in decision-making.&#xD;
  The results of the scale will be asses using descriptive analytics (Fisher exact test will be applied to compare the 2 groups) Multiple regression analysis will be applied using demographic data and health indicators.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">183</enrollment>
    <condition>Deafness</condition>
    <arm_group>
      <arm_group_label>Experimental VRI sign language interpretation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be provided with a Tablet of 14' inches with interrupted VRI in Colombian Sign Language. Professionally accredited Sign language interpreter. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-Communication</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental: primo control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants get welcome at the entry point of the hospital, they are not provided with VRI. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-communication</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Video Remote Interpretation</intervention_name>
      <description>To assess the effectiveness of the VRI system in improving communication outcomes between Deaf patients and doctors Produce a VRI model addressing the challenges faced by Deaf people that will be tested, implemented, and sustained in Bogota Colombia.</description>
      <arm_group_label>Experimental VRI sign language interpretation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Uses Colombian Sign Language as the preferred language.&#xD;
  &#xD;
            -  Enough sensorimotor, cognitive and communication skills to communicate independently&#xD;
               with health personnel&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Does not communicate using sign language.&#xD;
  &#xD;
            -  Additional impairments which affect language development or the use of sign language.&#xD;
  &#xD;
            -  Refusal of the participant's representative(s) to participate in the study,&#xD;
  &#xD;
            -  Refusal of the participant's representative(s) to participate in a modality of the&#xD;
               study,&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Clinica Nuestra Senora de la Paz</name>
        <address>
          <city>Bogota</city>
          <zip>110831</zip>
          <country>Colombia</country>
        </address>
      </facility>
      <contact>
        <last_name>Alexie Vallejo Silva, MD, MSc</last_name>
        <email>alexie.vallejo@urosario.edu.co</email>
      </contact>
      <contact_backup>
        <last_name>Jonathan Irreño Sotomonte, MD,</last_name>
        <email>Jonathan.Irreño@urosario.edu.co</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Hospital Universitario Mayor Mederi</name>
        <address>
          <city>Bogotá</city>
          <zip>111411</zip>
          <country>Colombia</country>
        </address>
      </facility>
      <contact>
        <last_name>Luis Carlos Venegas, MD,</last_name>
        <phone>5715600520</phone>
        <email>luis.venegas@mederi.com.co</email>
      </contact>
    </location>
    <location_countries>
      <country>Colombia</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Geneva, Switzerland</investigator_affiliation>
      <investigator_full_name>Minerva Rivas Velarde</investigator_full_name>
      <investigator_title>Group Leader</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Deafness</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05966623
  org study id: -2021-05-50-M1
  nct id: NCT05966623
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomise study that looks at what is the effectiveness of the VRI system in
        improving communication outcomes between Deaf patients and doctors versus the 'available
        standard of care of the usual communication tools, including informal interpretation, lip or
        note reading, using their mobile phones to contact a formal or informal interpreter, for Deaf
        patients aged 18 and older in Bogota Colombia
  Background and Rationale:
  
        In-person or VRI sign language interpretation is largely unavailable. In a scoping review,
        the researchers identified a knowledge gap regarding the quality of interpretation and
        training in sign language interpretation for health care. The researchers also found that
        this area is under-researched, and the evidence is scant. All available evidence came from
        high-income countries, which is particularly problematic given that most DHH persons live in
        low- and middle-income countries. Thus, the available literature shows that VRI may enable
        deaf users to overcome interpretation barriers and can potentially improve communication
        outcomes between them and health personnel within health care services. For VRI to be
        acceptable, sign language users require a VRI system supported by devices with large screens
        and a reliable internet connection, as well as qualified interpreters trained in medical
        interpretation. There is no clear data on the availability of VRI or in-person
        interpretation. Given the cost, VRI may be more available than in person. Available data tend
        to focus on assessing personal references of Deaf users in regards to interpretation, as well
        as interpreters' preferences and maximising recourses allocation.
  
        Objective(S):
  
        To assess the effectiveness of the VRI system in improving communication outcomes between
        Deaf patients and doctors Produce a VRI model addressing the challenges faced by Deaf people
        that will be tested, implemented, and sustained in Bogota, Colombia.
  
        Explanation for choice of comparator
  
        In-person or VRI sign language interpretation is largely unavailable. Thus, there is no clear
        data on the magnitude of the availability gap of VRI or in-person interpretation. In-person
        qualified sign language interpretation in the healthcare setting tends to be described as the
        ideal standard of service provision. Thus, it is largely unavailable even in HIC. The
        assumption is based upon minimal available evidence on the personal preferences of Deaf
        persons in the USA. There is no evidence that in-person interpretation is efficient in the
        context of weaker infrastructure, such as low sign language literacy rates across Deaf
        persons, lack of standard qualification of interpreters and lack of interpreters and
        sustainable financing in HIC. To my knowledge, there is no study assessing DPC while using
        sign language interpretation.
  
        Given the cost, VRI may be more sustainable than in-person. Assessing the efficiency of VRI
        versus the standard of care would be d of more value, given that there is no other effective
        intervention to compare.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Arm Intervention Experimental VRI sign language interpretation Participants will be welcome from their entry point to the hospital, they will attend a general check-up with a GP or other services and be provided with VRI until they leave Participants will be provided with a Tablet of 14' inches with interrupted VRI in Colombian Sign Language. Professionally accredited Sign language interpreter. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-Communication
  Experimental: primo control Participants get welcome at the entry point of the hospital, they will attend a general check-up with a GP or other services and they are not provided with by the study with VRI Participants get welcome at the entry point of the hospital, they are not provided with VRI. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-communication
  primary purpose: Health Services Research
  masking: None (Open Label)
  masking description: Single-blinded - The researcher needs to learn before the patient comes to the hospital as VRI needs to be organised. Thus, they will only know if the participants shall be assigned to the intervention or control group after the patient agrees to take part. Double blinding is not feasible as interpreters will not be available 24x7.
  measure: Communication outcomes
  time frame: 12 months
  description: The score of a selected' scale assesses A: creating a good interpersonal relationship, B: exchanging information, and C: Making treatment-related decisions that involve the patients in decision-making.
  The results of the scale will be asses using descriptive analytics (Fisher exact test will be applied to compare the 2 groups) Multiple regression analysis will be applied using demographic data and health indicators.
  arm group label: Experimental VRI sign language interpretation
  arm group type: Experimental
  description: Participants will be provided with a Tablet of 14' inches with interrupted VRI in Colombian Sign Language. Professionally accredited Sign language interpreter. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-Communication
  arm group label: Experimental: primo control
  arm group type: No Intervention
  description: Participants get welcome at the entry point of the hospital, they are not provided with VRI. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-communication
  intervention type: Other
  intervention name: Video Remote Interpretation
  description: To assess the effectiveness of the VRI system in improving communication outcomes between Deaf patients and doctors Produce a VRI model addressing the challenges faced by Deaf people that will be tested, implemented, and sustained in Bogota Colombia.
  arm group label: Experimental VRI sign language interpretation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  contact: 
  contact backup: 
  facility: 
  contact: 
  country: Colombia
  responsible party type: Principal Investigator
  investigator affiliation: University of Geneva, Switzerland
  investigator full name: Minerva Rivas Velarde
  investigator title: Group Leader
  mesh term: Deafness
  sharing ipd: No