<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/NCT03287700</url>
  </required_header>
  <id_info>
    <org_study_id>16IH004</org_study_id>
    <secondary_id>PB-PG-0815-20039</secondary_id>
    <nct_id>NCT03287700</nct_id>
  </id_info>
  <brief_title>Designing a Trial of Bilateral Cochlear Implantation in Adults</brief_title>
  <acronym>FOUNDATION</acronym>
  <official_title>Designing a Randomised Controlled Trial to Examine the Benefit of Bilateral Cochlear Implantation Compared With Unilateral Cochlear Implantation in Adults With Severe to Profound Deafness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nottingham University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Liverpool</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southampton</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of East Anglia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cochlear Implant Users Association, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nottingham University Hospitals NHS Trust</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>
      In the UK, cochlear implantation is the standard treatment for adults with&#xD;
      'severe-to-profound' deafness. This level of deafness means that without a cochlear implant&#xD;
      they have difficulty understanding what people are saying even when they wear hearing aids.&#xD;
      The NHS provides a cochlear implant for one ear even though these adults are deaf in both&#xD;
      ears. Two cochlear implants could help them understand speech in noisy environments, know&#xD;
      where to look to see who is talking, and avoid hazards outdoors.&#xD;
&#xD;
      The decision about who can receive cochlear implants and how many they can receive is based&#xD;
      on guidance from the National Institute for Health and Care Excellence (NICE). NICE agreed&#xD;
      that providing two cochlear implants can provide additional benefits over providing just one&#xD;
      implant. However, they decided that there is not enough evidence to show that these&#xD;
      additional benefits are worth the additional cost of providing the second implant. NICE&#xD;
      recommended that a clinical trial should be conducted to gather this evidence.&#xD;
&#xD;
      This study will consult with patients to explore whether the trial would be acceptable to&#xD;
      future implant recipients. The study will also work with clinicians to design a trial&#xD;
      comparing bilateral and unilateral implantation in adults. These clinicians will also be&#xD;
      surveyed to assess the acceptability of the trial. A group of clinicians that span the range&#xD;
      of professions involved in delivering the care pathway will be invited to attend a trial&#xD;
      design workshop to establish a consensus on acceptable trial design elements from a clinical&#xD;
      perspective. Representatives from cochlear implant manufacturers will be consulted to&#xD;
      determine possible strategies for securing industry support for a future trial. Those who run&#xD;
      cochlear implantation services will be engaged in a working group to gather information on&#xD;
      the current care pathway to inform future assessments of whether bilateral implantation could&#xD;
      be cost-effective.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design comprises focus groups, online surveys, a trial design workshop, a&#xD;
      manufacturer's forum, and a care pathway working group.&#xD;
&#xD;
      Focus groups Two focus groups will be conducted to explore issues around the acceptability of&#xD;
      the two-arm trial recommended by NICE. The recruitment strategy will target both individuals&#xD;
      who have been referred for a cochlear implant but have yet to receive one and also existing&#xD;
      users of a cochlear implant. The focus groups will explore issues such as acceptance of&#xD;
      randomisation, how to minimise the burden associated with participating, potential barriers&#xD;
      to participation, and how to communicate the purpose of the trial clearly and effectively to&#xD;
      prospective participants.&#xD;
&#xD;
      Online surveys Online surveys, informed by the focus groups, will be used to capture the&#xD;
      views of the wider population of patients and of clinicians who deliver cochlear implant&#xD;
      services on the acceptability of the trial. Both surveys will use open and closed questions.&#xD;
      The surveys will explore the acceptability of the trial.&#xD;
&#xD;
      Trial design workshop Following the focus groups and surveys, an all-day workshop will be&#xD;
      conducted with clinicians who deliver the current care pathway for cochlear implantation. The&#xD;
      workshop will comprise a focus group and a trial design session. The focus group will seek to&#xD;
      identify pertinent issues with the trial design from the perspective of the clinicians. The&#xD;
      group will then be tasked with reaching a consensus on a trial design that would be both&#xD;
      acceptable to them and which is feasible to conduct.&#xD;
&#xD;
      Manufacturer's forum Major manufacturers who supply cochlear implants to the NHS will be&#xD;
      invited to attend a manufacturer's forum near the end of the study. They will be presented&#xD;
      with the results of the acceptability assessment. The forum will explore whether the&#xD;
      manufacturers would consider supporting the trial.&#xD;
&#xD;
      Care pathway working group A working group of cochlear implant service coordinators will be&#xD;
      established to examine the existing decision analytic model commissioned by NICE and to&#xD;
      identify the aspects of the model that require updating. The group will identify those&#xD;
      parameters for which relevant information may be available from their own service records and&#xD;
      will be tasked to reach a consensus on individual values for each parameter that would&#xD;
      generally represent service provision across the providers. The group will also define&#xD;
      plausible ranges for each parameter which could be used in future sensitivity analyses of any&#xD;
      decision-analytic model.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 14, 2017</start_date>
  <completion_date type="Anticipated">August 2, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability of trial among patients</measure>
    <time_frame>Day 1 (Point at which the patient completes the online patient survey)</time_frame>
    <description>Proportion of surveyed patients who consider the proposed trial comparing bilateral cochlear implantation to unilateral cochlear implantation to be acceptable</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of trial among clinicians</measure>
    <time_frame>Day 1 (Point at which the clinician completes the online patient survey)</time_frame>
    <description>Proportion of surveyed clinicians who consider the proposed trial to be acceptable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Issues related to acceptability from patient perspective</measure>
    <time_frame>Day 1 (On the day(s) the patient focus groups are conducted)</time_frame>
    <description>Major themes related to acceptability from the perspectives of patients assessed using qualitative methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Issues related to acceptability from clinician perspective</measure>
    <time_frame>Day 1 (On the day the trial design workshop is conducted)</time_frame>
    <description>Major themes related to acceptability from the perspectives of clinicians assessed using qualitative methods</description>
  </secondary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Hearing Loss, Bilateral</condition>
  <condition>Hearing Loss, Sensorineural</condition>
  <arm_group>
    <arm_group_label>Focus group participants</arm_group_label>
    <description>Adults who have received a cochlear implant on the National Health Service (NHS) at an auditory implant service in the United Kingdom (UK) OR Adults who have been referred to a UK auditory implant programme for assessment for cochlear implantation but who have not yet been implanted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Online patient survey participants</arm_group_label>
    <description>Adults who have received a cochlear implant on the National Health Service (NHS) at an auditory implant service in the United Kingdom (UK)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Online clinician survey participants</arm_group_label>
    <description>Clinicians who deliver the current care pathway for cochlear implantation at auditory implant programmes providing NHS services in the UK</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trial design workshop participants</arm_group_label>
    <description>Clinicians who deliver the current care pathway for cochlear implantation at auditory implant programmes providing NHS services in the UK</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manufacturer's forum participants</arm_group_label>
    <description>Representatives of manufacturers of cochlear implants who provide devices on the NHS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Care pathway working group participants</arm_group_label>
    <description>Clinicians who deliver the current care pathway for cochlear implantation at auditory implant programmes providing NHS services in the UK</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention will be administered to any group in this observational study.</description>
    <arm_group_label>Care pathway working group participants</arm_group_label>
    <arm_group_label>Focus group participants</arm_group_label>
    <arm_group_label>Manufacturer's forum participants</arm_group_label>
    <arm_group_label>Online clinician survey participants</arm_group_label>
    <arm_group_label>Online patient survey participants</arm_group_label>
    <arm_group_label>Trial design workshop participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with bilateral severe to profound hearing loss that is eligible for cochlear&#xD;
        implantation in the United Kingdom following guidance from the National institute for&#xD;
        Health and Care Excellence (NICE), who have either already been implanted or who are being&#xD;
        assessed for eligibility to be implanted.&#xD;
&#xD;
        Clinicians who deliver cochlear implantation services on the National Health Service in the&#xD;
        UK.&#xD;
&#xD;
        Representatives of manufacturers of cochlear implant systems who supply implants to the&#xD;
        National Health Service in the UK.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants will be 18 years or older at the time consent is obtained.&#xD;
&#xD;
          -  Patients who participate in the focus groups and/or online survey must have received a&#xD;
             cochlear implant on the NHS in the UK or must be currently being assessed for&#xD;
             eligibility to receive a unilateral cochlear implantation by an NHS service provider.&#xD;
&#xD;
          -  Clinicians who participate in the trial design workshop and/or the online survey must&#xD;
             be employed by a provider of NHS cochlear implantation services in the UK and be a&#xD;
             clinically-trained professional who delivers one or more aspects of the cochlear&#xD;
             implantation care pathway.&#xD;
&#xD;
          -  Representatives from manufacturers who attend the industry forum must be employed by a&#xD;
             manufacturer of cochlear implants and hold a role that includes responsibility for&#xD;
             developing, co-ordinating, or managing research activity sponsored and/or funded by&#xD;
             the manufacturer.&#xD;
&#xD;
          -  Clinicians who participate in the care pathway working group must be employed by a&#xD;
             provider of NHS cochlear implantation services in the UK and have a head of service or&#xD;
             co-ordinator role in their cochlear implant service or have been delegated&#xD;
             responsibility to contribute on behalf of a head of service / co-ordinator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • None.&#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>
  <overall_official>
    <last_name>Padraig T Kitterick, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Matthew Smyth</last_name>
    <phone>+44 151 795 8780</phone>
    <email>foundation.study@liverpool.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medicines for Children Clinical Trials Unit, Clinical Trials Research Centre, University of Liverpool</name>
      <address>
        <city>Liverpool</city>
        <zip>L12 2AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Smyth</last_name>
      <phone>+44 151 795 8780</phone>
      <email>foundation.study@liverpool.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>May 21, 2019</last_update_submitted>
  <last_update_submitted_qc>May 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Hearing Loss, Sensorineural</mesh_term>
    <mesh_term>Hearing Loss, Bilateral</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03287700
org study id: 16IH004
secondary id: PB-PG-0815-20039
nct id: NCT03287700
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the UK, cochlear implantation is the standard treatment for adults with
      'severe-to-profound' deafness. This level of deafness means that without a cochlear implant
      they have difficulty understanding what people are saying even when they wear hearing aids.
      The NHS provides a cochlear implant for one ear even though these adults are deaf in both
      ears. Two cochlear implants could help them understand speech in noisy environments, know
      where to look to see who is talking, and avoid hazards outdoors.

      The decision about who can receive cochlear implants and how many they can receive is based
      on guidance from the National Institute for Health and Care Excellence (NICE). NICE agreed
      that providing two cochlear implants can provide additional benefits over providing just one
      implant. However, they decided that there is not enough evidence to show that these
      additional benefits are worth the additional cost of providing the second implant. NICE
      recommended that a clinical trial should be conducted to gather this evidence.

      This study will consult with patients to explore whether the trial would be acceptable to
      future implant recipients. The study will also work with clinicians to design a trial
      comparing bilateral and unilateral implantation in adults. These clinicians will also be
      surveyed to assess the acceptability of the trial. A group of clinicians that span the range
      of professions involved in delivering the care pathway will be invited to attend a trial
      design workshop to establish a consensus on acceptable trial design elements from a clinical
      perspective. Representatives from cochlear implant manufacturers will be consulted to
      determine possible strategies for securing industry support for a future trial. Those who run
      cochlear implantation services will be engaged in a working group to gather information on
      the current care pathway to inform future assessments of whether bilateral implantation could
      be cost-effective.
The study design comprises focus groups, online surveys, a trial design workshop, a
      manufacturer's forum, and a care pathway working group.

      Focus groups Two focus groups will be conducted to explore issues around the acceptability of
      the two-arm trial recommended by NICE. The recruitment strategy will target both individuals
      who have been referred for a cochlear implant but have yet to receive one and also existing
      users of a cochlear implant. The focus groups will explore issues such as acceptance of
      randomisation, how to minimise the burden associated with participating, potential barriers
      to participation, and how to communicate the purpose of the trial clearly and effectively to
      prospective participants.

      Online surveys Online surveys, informed by the focus groups, will be used to capture the
      views of the wider population of patients and of clinicians who deliver cochlear implant
      services on the acceptability of the trial. Both surveys will use open and closed questions.
      The surveys will explore the acceptability of the trial.

      Trial design workshop Following the focus groups and surveys, an all-day workshop will be
      conducted with clinicians who deliver the current care pathway for cochlear implantation. The
      workshop will comprise a focus group and a trial design session. The focus group will seek to
      identify pertinent issues with the trial design from the perspective of the clinicians. The
      group will then be tasked with reaching a consensus on a trial design that would be both
      acceptable to them and which is feasible to conduct.

      Manufacturer's forum Major manufacturers who supply cochlear implants to the NHS will be
      invited to attend a manufacturer's forum near the end of the study. They will be presented
      with the results of the acceptability assessment. The forum will explore whether the
      manufacturers would consider supporting the trial.

      Care pathway working group A working group of cochlear implant service coordinators will be
      established to examine the existing decision analytic model commissioned by NICE and to
      identify the aspects of the model that require updating. The group will identify those
      parameters for which relevant information may be available from their own service records and
      will be tasked to reach a consensus on individual values for each parameter that would
      generally represent service provision across the providers. The group will also define
      plausible ranges for each parameter which could be used in future sensitivity analyses of any
      decision-analytic model.
observational model: Other
time perspective: Cross-Sectional
measure: Acceptability of trial among patients
time frame: Day 1 (Point at which the patient completes the online patient survey)
description: Proportion of surveyed patients who consider the proposed trial comparing bilateral cochlear implantation to unilateral cochlear implantation to be acceptable
measure: Acceptability of trial among clinicians
time frame: Day 1 (Point at which the clinician completes the online patient survey)
description: Proportion of surveyed clinicians who consider the proposed trial to be acceptable
measure: Issues related to acceptability from patient perspective
time frame: Day 1 (On the day(s) the patient focus groups are conducted)
description: Major themes related to acceptability from the perspectives of patients assessed using qualitative methods
measure: Issues related to acceptability from clinician perspective
time frame: Day 1 (On the day the trial design workshop is conducted)
description: Major themes related to acceptability from the perspectives of clinicians assessed using qualitative methods
arm group label: Focus group participants
description: Adults who have received a cochlear implant on the National Health Service (NHS) at an auditory implant service in the United Kingdom (UK) OR Adults who have been referred to a UK auditory implant programme for assessment for cochlear implantation but who have not yet been implanted
arm group label: Online patient survey participants
description: Adults who have received a cochlear implant on the National Health Service (NHS) at an auditory implant service in the United Kingdom (UK)
arm group label: Online clinician survey participants
description: Clinicians who deliver the current care pathway for cochlear implantation at auditory implant programmes providing NHS services in the UK
arm group label: Trial design workshop participants
description: Clinicians who deliver the current care pathway for cochlear implantation at auditory implant programmes providing NHS services in the UK
arm group label: Manufacturer's forum participants
description: Representatives of manufacturers of cochlear implants who provide devices on the NHS
arm group label: Care pathway working group participants
description: Clinicians who deliver the current care pathway for cochlear implantation at auditory implant programmes providing NHS services in the UK
intervention type: Other
intervention name: No intervention
description: No intervention will be administered to any group in this observational study.
arm group label: Care pathway working group participants
arm group label: Focus group participants
arm group label: Manufacturer's forum participants
arm group label: Online clinician survey participants
arm group label: Online patient survey participants
arm group label: Trial design workshop participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Padraig T Kitterick, PhD
role: Principal Investigator
affiliation: University of Nottingham
last name: Matthew Smyth
phone: +44 151 795 8780
email: foundation.study@liverpool.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Sensorineural
mesh term: Hearing Loss, Bilateral
sharing ipd: Undecided