<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/NCT04404803</url>
  </required_header>
  <id_info>
    <org_study_id>B00366</org_study_id>
    <nct_id>NCT04404803</nct_id>
  </id_info>
  <brief_title>Motivations and Barriers to Participating in Ophthalmology Research Projects</brief_title>
  <official_title>Motivations and Barriers to Participating in Ophthalmology Research Projects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Manchester University NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Manchester University NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The primary objective of this project is to understand the reasons why patients agree /&#xD;
      disagree to take part in ophthalmology research. This will be done by asking participants to&#xD;
      complete a Research Questionnaire.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 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>Assessment of motivations to participating in ophthalmology research.</measure>
    <time_frame>5 years</time_frame>
    <description>Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of barriers in participating in ophthalmology research</measure>
    <time_frame>5 years</time_frame>
    <description>Questionnaire</description>
  </primary_outcome>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Eye Diseases</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire</intervention_name>
    <description>Patients will be asked to complete a questionnaire about the reasons why they agree / decline to take part in research.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All individuals will be considered for inclusion in this study regardless of age,&#xD;
        disability, gender reassignment, marriage and civil partnership, pregnancy and maternity,&#xD;
        race, religion and belief, sex, and sexual orientation except where the study inclusion and&#xD;
        exclusion criteria explicitly state otherwise.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 16 years old&#xD;
&#xD;
          -  Willing to participate by completing the questionnaire&#xD;
&#xD;
          -  Must be able to speak and read English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 16 years of age&#xD;
&#xD;
          -  Not willing to complete the questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Monika Cien</last_name>
    <phone>01617011765</phone>
    <phone_ext>11765</phone_ext>
    <email>monika.cien@mft.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hannah Kindrade</last_name>
    <phone>0161 701 0566</phone>
    <phone_ext>10566</phone_ext>
    <email>hannah.kinrade@mft.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Monika Cien</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Monika Cien</last_name>
      <phone>01617011765</phone>
      <phone_ext>11765</phone_ext>
      <email>monika.cien@mft.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</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>Eye Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04404803
org study id: B00366
nct id: NCT04404803
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary objective of this project is to understand the reasons why patients agree /
      disagree to take part in ophthalmology research. This will be done by asking participants to
      complete a Research Questionnaire.
observational model: Cohort
time perspective: Prospective
measure: Assessment of motivations to participating in ophthalmology research.
time frame: 5 years
description: Questionnaire
measure: Assessment of barriers in participating in ophthalmology research
time frame: 5 years
description: Questionnaire
intervention type: Other
intervention name: questionnaire
description: Patients will be asked to complete a questionnaire about the reasons why they agree / decline to take part in research.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
last name: Monika Cien
phone: 01617011765
phone ext: 11765
email: monika.cien@mft.nhs.uk
last name: Hannah Kindrade
phone: 0161 701 0566
phone ext: 10566
email: hannah.kinrade@mft.nhs.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Eye Diseases
sharing ipd: No