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/NCT06027866</url>
    </required_header>
    <id_info>
      <org_study_id>B22/04</org_study_id>
      <nct_id>NCT06027866</nct_id>
    </id_info>
    <brief_title>A Speech Recognition Application as a Communication Aid for Acute and Critical Care Patients With Tracheostomies</brief_title>
    <acronym>SRAVI</acronym>
    <official_title>A Mixed Method Prospective Observational Cohort Study to Test Speech Recognition Application for the Voice Impaired (SRAVI) as a Communication Aid for Acute and Critical Care Patients With Tracheostomies.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Queen's University, Belfast</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Northern Ireland HSc Public Health Agency (Research &amp; Development Division)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Queen's University, Belfast</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>
        Patients in acute and critical care often undergo a tracheostomy. A tracheostomy is an&#xD;
        incision at the front of the neck to insert a breathing tube directly into the airway. The&#xD;
        tube sits in place in the airway using an inflated air-filled cuff. This means that no&#xD;
        airflow is directed up and out past the vocal cords through the voice box, and speech is not&#xD;
        possible. Being unable to speak can cause distress to patients and may place them at an&#xD;
        increased risk of harm if they are unable to express their wishes or needs. It can also&#xD;
        increase stress for relatives and healthcare staff as they try to understand what patients&#xD;
        are trying to say. Usually when patients cannot talk, staff use different items to help, like&#xD;
        a pen and paper. A new communication device that runs on a smartphone or tablet has recently&#xD;
        been developed. It is for patients with tracheostomies and works by reading lip movements and&#xD;
        translating them into words on the device screen.&#xD;
  &#xD;
        The aim of this study is to find out if providing adult acute and critical care patients who&#xD;
        have a tracheostomy with the use of this lip-reading device could improve how they&#xD;
        communicate. This study will include:&#xD;
  &#xD;
          1. Using the lip-reading device in acute and critical care to test if it helps patients&#xD;
             with tracheostomies to communicate better.&#xD;
  &#xD;
          2. Interviews with patients, relatives and focus groups/interviews with staff to find out&#xD;
             their views on communication including the use of the new lipreading device.&#xD;
  &#xD;
          3. Follow-up with patients approximately 3-months after acute/critical care discharge to&#xD;
             complete some further questions about their physical and mental health.&#xD;
  &#xD;
        The study will take place in three critical care units and one acute care unit in Northern&#xD;
        Ireland and is expected to last 18 months. The study has been funded by the Public Health&#xD;
        Agency Research and Development Division.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study Design: This is a mixed-method, multi-centre prospective observational cohort study to&#xD;
        establish the feasibility of SRAVI. Mixed methods include:&#xD;
  &#xD;
          -  A multi-centre prospective observational cohort study of SRAVI as an addition to usual&#xD;
             communication aids.&#xD;
  &#xD;
          -  Qualitative interviews/focus groups to inform future study design by exploring&#xD;
             patients', their significant others and the critical care MDTs' subjective experiences&#xD;
             of the study intervention and outcome measures.&#xD;
  &#xD;
        Sample size: The investigators aim to recruit a minimum target of 55 patients. For every&#xD;
        patient recruited, the investigators anticipate that three qualitative interviews will be&#xD;
        undertaken (i.e., with the patient, their significant other, and at least one healthcare&#xD;
        professional). Therefore, a feasible target recruitment is 165 participants.&#xD;
  &#xD;
        Consent: Written informed consent will be obtained from participants or a personal or&#xD;
        professional consultee in accordance with ethical approval.&#xD;
  &#xD;
        Data collection: Data will be collected by the investigators and recorded in the study case&#xD;
        report form (CRF).&#xD;
  &#xD;
        Baseline data&#xD;
  &#xD;
          -  Inclusion/exclusion criteria and eligibility screen&#xD;
  &#xD;
          -  Sex&#xD;
  &#xD;
          -  Age on admission to hospital&#xD;
  &#xD;
          -  Date of acute/critical care admission&#xD;
  &#xD;
          -  Admission diagnosis&#xD;
  &#xD;
          -  Date of tracheostomy insertion during acute/critical care&#xD;
  &#xD;
        Daily data collected&#xD;
  &#xD;
          -  CAM-ICU score (critical care patients only)&#xD;
  &#xD;
          -  Frequency of SRAVI delivery&#xD;
  &#xD;
          -  Compliance with SRAVI use&#xD;
  &#xD;
          -  Adverse events&#xD;
  &#xD;
        Feasibility and clinical outcome data collected in acute/critical care&#xD;
  &#xD;
          -  Screening&#xD;
  &#xD;
          -  Recruitment rates&#xD;
  &#xD;
          -  Adverse events&#xD;
  &#xD;
          -  Delirium (critical care patients only)&#xD;
  &#xD;
        Data collected after critical care discharge&#xD;
  &#xD;
        • Duration of critical care stay&#xD;
  &#xD;
        Data collected during virtual/telephone/in-person follow-up 3 months following acute/critical&#xD;
        care discharge:&#xD;
  &#xD;
          -  Health related quality of life (HRQoL)&#xD;
  &#xD;
          -  Post-Traumatic Stress Disorder (PTSD)&#xD;
  &#xD;
          -  Anxiety and depression&#xD;
  &#xD;
          -  Cognitive status&#xD;
  &#xD;
        Data analysis: Descriptive analysis will be used to analyse data from the observational&#xD;
        cohort study. Numbers of patients screened, eligible, recruited, consented, and withdrawn&#xD;
        from the study will be reported. Baseline demographic and clinical data will be summarised&#xD;
        for study participants. Continuous variables will be summarised as mean (standard deviation)&#xD;
        and median (interquartile range) and categorical variables will be summarised as number&#xD;
        (percent).&#xD;
  &#xD;
        Qualitative interviews/focus groups: Interviews/focus groups will be conducted by the&#xD;
        investigator. Interview schedules/focus group topic guides will be developed from discussions&#xD;
        within the research team, the patient advisory group, and from literature around study&#xD;
        participation. The schedules will include a pre-defined list of questions that will be&#xD;
        informed by the objectives of the study. The schedule will enable all participants to be&#xD;
        asked similar questions and thus permit comparison of themes across each subject during data&#xD;
        analysis.&#xD;
  &#xD;
        Qualitative data collection: Interviews/focus groups will be audio recorded and&#xD;
        professionally transcribed verbatim using an authorised transcription service. All&#xD;
        identifying information will be removed prior to analysis. Transcriptions will be reviewed&#xD;
        and verified prior to analysis by the research fellow by comparing the audio and written&#xD;
        versions to identify errors.&#xD;
  &#xD;
        Qualitative analysis: Qualitative data will be subjected to a thematic analysis, using Newell&#xD;
        and Burnard's framework. This approach will permit an inductive process of drawing out&#xD;
        important data-driven themes and a deductive process relating the major themes that emerge to&#xD;
        the pre-defined objectives of the research. A process of constant comparison, reading, and&#xD;
        re-reading of the data will enable identification of emerging themes. The process will be&#xD;
        facilitated by using a computer-assisted qualitative data software package, NVIVO.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 26, 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Capability of patients to use SRAVI as a communication aid.</measure>
      <time_frame>From date of study enrolment until patient no longer requires the lipreading app whilst in the acute or critical care setting (or discharge from the acute or critical care setting). Censored at 8-weeks.</time_frame>
      <description>This will be measurement through the frequency of SRAVI use; words correctly captured by SRAVI and the frequency of patients who could not use SRAVI and reverted to other communication aids.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of SRAVI as a communication aid</measure>
      <time_frame>Following patients' discharge from the acute/critical care facility and up to three months following acute/critical care discharge. Staff focus groups/interviews will be conducted with staff after they have used the intervention up to an 8-week period.</time_frame>
      <description>This will be measured through qualitative interviews with patients and relatives, and focus groups/interviews with members of the multidisciplinary healthcare team.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Length of critical care stay</measure>
      <time_frame>From critical care admission to critical care discharge, censored at 8-weeks</time_frame>
      <description>Total number of days patient spent in critical care</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of hospital length of stay</measure>
      <time_frame>From hospital admission to hospital discharge, censored at 3-months</time_frame>
      <description>Total number of days patient spent in hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of delirium during critical care stay</measure>
      <time_frame>Assessed twice per shift using the Confusion Agitation Method for ICU (CAM-ICU) tool from date of study enrolment until SRAVI no longer used or discharge from critical care. Censored at 8-weeks</time_frame>
      <description>Did participants have delirium during their critical care stay?</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health related Quality of Life</measure>
      <time_frame>Three months following acute/critical care discharge</time_frame>
      <description>Measured by the European Quality of Life-5 Dimensions (EQoL-5D</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety and depression</measure>
      <time_frame>Three months following acute/critical care discharge</time_frame>
      <description>Measured by the Hospital Anxiety and Depression Scale (HADS).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-traumatic stress disorder</measure>
      <time_frame>Three months following acute/critical care discharge</time_frame>
      <description>Measured by the Impact of Events Scale-Revised (IES-R).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive status</measure>
      <time_frame>Three months following acute/critical care discharge</time_frame>
      <description>Measured by the Montreal Cognitive Assessment-BLIND (MOCA-BLIND).</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">55</enrollment>
    <condition>Tracheostomy</condition>
    <condition>Communication</condition>
    <condition>Acute/Critical Illness</condition>
    <arm_group>
      <arm_group_label>Tracheostomy patients</arm_group_label>
      <description>All consenting participants will receive access to SRAVI (Speech Recognition Application for the Voice Impaired), a communication aid for speech-impaired patients. SRAVI is a software-based mobile application ('app') and can be downloaded onto any device with a standard forward facing camera (e.g., smartphone, tablet). SRAVI has been registered with the Medical and Healthcare products Regulatory Agency (MHRA) and CE marked for intended use. SRAVI is based on Visual Speech Recognition (VSR) technology. Specifically, the LipRead technology can determine speech by analysing the movements of a user's lips as they speak into a camera.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SRAVI (Speech Recognition Application for the Voice Impaired)</intervention_name>
      <description>Speech Recognition Application for the Voice Impaired (SRAVI) is a novel communication aid developed by Liopa (a company formed by Queen's University Belfast (QUB) and the Centre for Security Information Technologies (CSIT), QUB). SRAVI is an application-based lip-reading system, and the application ('app') can be downloaded onto any device with a standard forward facing camera (e.g., smartphone, tablet). When the device is held in front of a patient, it will track lip movement and identify phrases being mouthed.</description>
      <arm_group_label>Tracheostomy patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Acute/critical care tracheostomy patients&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 18 years and over&#xD;
  &#xD;
            -  Patients who acquire a tracheostomy in acute/critical care&#xD;
  &#xD;
            -  Patients can move lips in a way that articulates words&#xD;
  &#xD;
            -  Able to communicate in English (a current requirement of the technology)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -Patient declined consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Bronagh Blackwood, PhD</last_name>
      <phone>028 90976379</phone>
      <email>b.blackwood@qub.ac.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Wellcome-Wolfson Institute for Experimental Medicine Queen's University Belfast</name>
        <address>
          <city>Belfast</city>
          <state>Northern Ireland</state>
          <zip>BT9 7BL</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bronagh Blackwood</last_name>
        <phone>+442890976379</phone>
        <email>b.blackwood@qub.ac.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Queen's University, Belfast</investigator_affiliation>
      <investigator_full_name>Bronagh Blackwood</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Critical Illness</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/NCT06027866
  org study id: B22/04
  nct id: NCT06027866
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients in acute and critical care often undergo a tracheostomy. A tracheostomy is an
        incision at the front of the neck to insert a breathing tube directly into the airway. The
        tube sits in place in the airway using an inflated air-filled cuff. This means that no
        airflow is directed up and out past the vocal cords through the voice box, and speech is not
        possible. Being unable to speak can cause distress to patients and may place them at an
        increased risk of harm if they are unable to express their wishes or needs. It can also
        increase stress for relatives and healthcare staff as they try to understand what patients
        are trying to say. Usually when patients cannot talk, staff use different items to help, like
        a pen and paper. A new communication device that runs on a smartphone or tablet has recently
        been developed. It is for patients with tracheostomies and works by reading lip movements and
        translating them into words on the device screen.
  
        The aim of this study is to find out if providing adult acute and critical care patients who
        have a tracheostomy with the use of this lip-reading device could improve how they
        communicate. This study will include:
  
          1. Using the lip-reading device in acute and critical care to test if it helps patients
             with tracheostomies to communicate better.
  
          2. Interviews with patients, relatives and focus groups/interviews with staff to find out
             their views on communication including the use of the new lipreading device.
  
          3. Follow-up with patients approximately 3-months after acute/critical care discharge to
             complete some further questions about their physical and mental health.
  
        The study will take place in three critical care units and one acute care unit in Northern
        Ireland and is expected to last 18 months. The study has been funded by the Public Health
        Agency Research and Development Division.
  Study Design: This is a mixed-method, multi-centre prospective observational cohort study to
        establish the feasibility of SRAVI. Mixed methods include:
  
          -  A multi-centre prospective observational cohort study of SRAVI as an addition to usual
             communication aids.
  
          -  Qualitative interviews/focus groups to inform future study design by exploring
             patients', their significant others and the critical care MDTs' subjective experiences
             of the study intervention and outcome measures.
  
        Sample size: The investigators aim to recruit a minimum target of 55 patients. For every
        patient recruited, the investigators anticipate that three qualitative interviews will be
        undertaken (i.e., with the patient, their significant other, and at least one healthcare
        professional). Therefore, a feasible target recruitment is 165 participants.
  
        Consent: Written informed consent will be obtained from participants or a personal or
        professional consultee in accordance with ethical approval.
  
        Data collection: Data will be collected by the investigators and recorded in the study case
        report form (CRF).
  
        Baseline data
  
          -  Inclusion/exclusion criteria and eligibility screen
  
          -  Sex
  
          -  Age on admission to hospital
  
          -  Date of acute/critical care admission
  
          -  Admission diagnosis
  
          -  Date of tracheostomy insertion during acute/critical care
  
        Daily data collected
  
          -  CAM-ICU score (critical care patients only)
  
          -  Frequency of SRAVI delivery
  
          -  Compliance with SRAVI use
  
          -  Adverse events
  
        Feasibility and clinical outcome data collected in acute/critical care
  
          -  Screening
  
          -  Recruitment rates
  
          -  Adverse events
  
          -  Delirium (critical care patients only)
  
        Data collected after critical care discharge
  
        • Duration of critical care stay
  
        Data collected during virtual/telephone/in-person follow-up 3 months following acute/critical
        care discharge:
  
          -  Health related quality of life (HRQoL)
  
          -  Post-Traumatic Stress Disorder (PTSD)
  
          -  Anxiety and depression
  
          -  Cognitive status
  
        Data analysis: Descriptive analysis will be used to analyse data from the observational
        cohort study. Numbers of patients screened, eligible, recruited, consented, and withdrawn
        from the study will be reported. Baseline demographic and clinical data will be summarised
        for study participants. Continuous variables will be summarised as mean (standard deviation)
        and median (interquartile range) and categorical variables will be summarised as number
        (percent).
  
        Qualitative interviews/focus groups: Interviews/focus groups will be conducted by the
        investigator. Interview schedules/focus group topic guides will be developed from discussions
        within the research team, the patient advisory group, and from literature around study
        participation. The schedules will include a pre-defined list of questions that will be
        informed by the objectives of the study. The schedule will enable all participants to be
        asked similar questions and thus permit comparison of themes across each subject during data
        analysis.
  
        Qualitative data collection: Interviews/focus groups will be audio recorded and
        professionally transcribed verbatim using an authorised transcription service. All
        identifying information will be removed prior to analysis. Transcriptions will be reviewed
        and verified prior to analysis by the research fellow by comparing the audio and written
        versions to identify errors.
  
        Qualitative analysis: Qualitative data will be subjected to a thematic analysis, using Newell
        and Burnard's framework. This approach will permit an inductive process of drawing out
        important data-driven themes and a deductive process relating the major themes that emerge to
        the pre-defined objectives of the research. A process of constant comparison, reading, and
        re-reading of the data will enable identification of emerging themes. The process will be
        facilitated by using a computer-assisted qualitative data software package, NVIVO.
  observational model: Cohort
  time perspective: Prospective
  measure: Capability of patients to use SRAVI as a communication aid.
  time frame: From date of study enrolment until patient no longer requires the lipreading app whilst in the acute or critical care setting (or discharge from the acute or critical care setting). Censored at 8-weeks.
  description: This will be measurement through the frequency of SRAVI use; words correctly captured by SRAVI and the frequency of patients who could not use SRAVI and reverted to other communication aids.
  measure: Acceptability of SRAVI as a communication aid
  time frame: Following patients' discharge from the acute/critical care facility and up to three months following acute/critical care discharge. Staff focus groups/interviews will be conducted with staff after they have used the intervention up to an 8-week period.
  description: This will be measured through qualitative interviews with patients and relatives, and focus groups/interviews with members of the multidisciplinary healthcare team.
  measure: Length of critical care stay
  time frame: From critical care admission to critical care discharge, censored at 8-weeks
  description: Total number of days patient spent in critical care
  measure: Duration of hospital length of stay
  time frame: From hospital admission to hospital discharge, censored at 3-months
  description: Total number of days patient spent in hospital
  measure: Occurrence of delirium during critical care stay
  time frame: Assessed twice per shift using the Confusion Agitation Method for ICU (CAM-ICU) tool from date of study enrolment until SRAVI no longer used or discharge from critical care. Censored at 8-weeks
  description: Did participants have delirium during their critical care stay?
  measure: Health related Quality of Life
  time frame: Three months following acute/critical care discharge
  description: Measured by the European Quality of Life-5 Dimensions (EQoL-5D
  measure: Anxiety and depression
  time frame: Three months following acute/critical care discharge
  description: Measured by the Hospital Anxiety and Depression Scale (HADS).
  measure: Post-traumatic stress disorder
  time frame: Three months following acute/critical care discharge
  description: Measured by the Impact of Events Scale-Revised (IES-R).
  measure: Cognitive status
  time frame: Three months following acute/critical care discharge
  description: Measured by the Montreal Cognitive Assessment-BLIND (MOCA-BLIND).
  arm group label: Tracheostomy patients
  description: All consenting participants will receive access to SRAVI (Speech Recognition Application for the Voice Impaired), a communication aid for speech-impaired patients. SRAVI is a software-based mobile application ('app') and can be downloaded onto any device with a standard forward facing camera (e.g., smartphone, tablet). SRAVI has been registered with the Medical and Healthcare products Regulatory Agency (MHRA) and CE marked for intended use. SRAVI is based on Visual Speech Recognition (VSR) technology. Specifically, the LipRead technology can determine speech by analysing the movements of a user's lips as they speak into a camera.
  intervention type: Device
  intervention name: SRAVI (Speech Recognition Application for the Voice Impaired)
  description: Speech Recognition Application for the Voice Impaired (SRAVI) is a novel communication aid developed by Liopa (a company formed by Queen's University Belfast (QUB) and the Centre for Security Information Technologies (CSIT), QUB). SRAVI is an application-based lip-reading system, and the application ('app') can be downloaded onto any device with a standard forward facing camera (e.g., smartphone, tablet). When the device is held in front of a patient, it will track lip movement and identify phrases being mouthed.
  arm group label: Tracheostomy patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bronagh Blackwood, PhD
  phone: 028 90976379
  email: b.blackwood@qub.ac.uk
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: Queen's University, Belfast
  investigator full name: Bronagh Blackwood
  investigator title: Professor
  mesh term: Critical Illness
  sharing ipd: No