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/NCT05964491</url>
    </required_header>
    <id_info>
      <org_study_id>10857</org_study_id>
      <nct_id>NCT05964491</nct_id>
    </id_info>
    <brief_title>Video Resources for People With Chronic Obstructive Pulmonary Disease: An Exploratory Qualitative Study</brief_title>
    <official_title>Video Resources for People With Chronic Obstructive Pulmonary Disease: An Exploratory Qualitative Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Teesside University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>International Primary Care Respiratory Group</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Teesside University</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>
        The IPCRG &amp; Teesside University have searched the internet for video self management content&#xD;
        for people living with COPD. Resources were reviewed by healthcare professionals and&#xD;
        developed into a digital magazine to support people living with chronic obstructive Pulmonary&#xD;
        Disease (COPD). The aims of this study are to&#xD;
  &#xD;
          1. evaluate the use of the digital magazine format with video self-management content from&#xD;
             an end user perspective, including&#xD;
  &#xD;
               1. what characteristics a good video resource should have&#xD;
  &#xD;
               2. what information is important to people with COPD to include in videos and digital&#xD;
                  magazines,&#xD;
  &#xD;
               3. the useability of a digital magazine format&#xD;
  &#xD;
          2. Explore the opinions, experiences and preferences of people living with COPD for&#xD;
             accessing online self-management content including barriers and facilitators for&#xD;
             accessing online self-management video content&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The use of online sources of information for chronic disease management has steadily&#xD;
        increased over recent years as technology becomes more intertwined with healthcare 1-3. Older&#xD;
        adults, including those with COPD are now more likely to access online based video resources&#xD;
        for information and advice on how to help their symptoms and health related quality of life&#xD;
        using smart phones and tablets 2. During the Covid-19 pandemic many healthcare services,&#xD;
        patient support groups and individuals living with chronic diseases produced video content&#xD;
        that is freely accessible online 4. A recent project by the IPCRG to curate evidence-based&#xD;
        video resources into a digital magazine discovered that content quality varied vastly and&#xD;
        gaps in resources still remained 5. With the growing use of online video resources there is a&#xD;
        need to establish what video resources need to have in terms of content, quality and personal&#xD;
        appeal for people living with COPD to successfully use at aid self-management 6,7. The&#xD;
        digital magazine was created with the understanding that it would be accessible to those who&#xD;
        were not digitally excluded and appeal to those who had adequate digital literacy skills,&#xD;
        however there are people with COPD who are digitally excluded and have varying degrees of&#xD;
        digital literacy skills 8,9. The magazine format was chosen to provide a recognisable and&#xD;
        easily navigated format however, it is not clear what formats, access and literacy levels are&#xD;
        necessary to support the use of online video resources, in particular this digital&#xD;
        magazine-based collation of videos 8.&#xD;
  &#xD;
        The aims of this study are to&#xD;
  &#xD;
          1. evaluate the use of the digital magazine format with video self-management content from&#xD;
             an end user perspective, including&#xD;
  &#xD;
               1. what characteristics a good video resource should have&#xD;
  &#xD;
               2. what information is important to people with COPD to include in videos and digital&#xD;
                  magazines,&#xD;
  &#xD;
               3. the useability of a digital magazine format&#xD;
  &#xD;
          2. Explore the opinions, experiences and preferences of people living with COPD for&#xD;
             accessing online self-management content including barriers and facilitators for&#xD;
             accessing online self-management video content&#xD;
  &#xD;
        3-4 focus groups of ideally 4-8 people with COPD in each group will be conducted to discuss&#xD;
        the use and make up of online self-management video content and wider experience of using&#xD;
        online video resources for health information.&#xD;
  &#xD;
        People with COPD will be recruited using the networks of those involved in the IPCRG project&#xD;
        such as UK based support and exercise groups for people with COPD&#xD;
  &#xD;
        Once returned, participants will be booked into online or face to face focus groups of around&#xD;
        4-8 people. Prior to attending to the focus groups, participants will be (1) asked to&#xD;
        complete an eHEALS measure of digital literacy either over the phone with a researcher or&#xD;
        return an electronic copy and (2) they will be requested to review a digital magazine.&#xD;
  &#xD;
        The focus group will be facilitated by a researcher with experience in respiratory&#xD;
        rehabilitation who has not been involved in developing the digital magazine based on a topic&#xD;
        guide developed using extant literature and steering group discussions.&#xD;
  &#xD;
        Focus groups would be transcribed verbatim and analysed by a steering group member with&#xD;
        experience in respiratory rehabilitation and the researcher who facilitated the focus groups&#xD;
        separately using NVivo software and an inductive thematic analysis approach 10. Themes will&#xD;
        be discussed with a further researcher and finalised by consensus&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 20, 2022</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</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>Qualitative data</measure>
      <time_frame>baseline</time_frame>
      <description>Focus group transcripts</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>eHEALS questionnaire</measure>
      <time_frame>baseline</time_frame>
      <description>Questionnaire about confidence finding and using electronic based health information</description>
    </secondary_outcome>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Chronic Obstructive Pulmonary Disease</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention</intervention_name>
      <description>No intervention studied</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          People living with a medically confirmed diagnosis of COPD or their carers, partners or&#xD;
          loved ones.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Inclusion criteria will be anyone with a reported medical diagnosis of COPD, who is&#xD;
               able to converse in English and has used a device to access the internet. Or the&#xD;
               carers, partners or loved ones of someone living with COPD.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#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_contact>
      <last_name>Kirsti J Loughran, PhD</last_name>
      <phone>07385086743</phone>
      <email>k.loughran@tees.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Laura Cordova-Rivera, PhD</last_name>
      <email>l.cordovarivera@tees.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Teesside University</name>
        <address>
          <city>Middlesbrough</city>
          <zip>TS1 3BX</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kirsti J Loughran, PhD</last_name>
        <phone>07385086743</phone>
        <email>k.loughran@tees.ac.uk</email>
      </contact>
      <contact_backup>
        <last_name>Laura Cordova Rivera, PhD</last_name>
        <email>l.cordovarivera@tees.ac.uk</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 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>Teesside University</investigator_affiliation>
      <investigator_full_name>Kirsti Loughran</investigator_full_name>
      <investigator_title>Research Fellow</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Obstructive</mesh_term>
      <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT05964491
  org study id: 10857
  nct id: NCT05964491
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The IPCRG & Teesside University have searched the internet for video self management content
        for people living with COPD. Resources were reviewed by healthcare professionals and
        developed into a digital magazine to support people living with chronic obstructive Pulmonary
        Disease (COPD). The aims of this study are to
  
          1. evaluate the use of the digital magazine format with video self-management content from
             an end user perspective, including
  
               1. what characteristics a good video resource should have
  
               2. what information is important to people with COPD to include in videos and digital
                  magazines,
  
               3. the useability of a digital magazine format
  
          2. Explore the opinions, experiences and preferences of people living with COPD for
             accessing online self-management content including barriers and facilitators for
             accessing online self-management video content
  The use of online sources of information for chronic disease management has steadily
        increased over recent years as technology becomes more intertwined with healthcare 1-3. Older
        adults, including those with COPD are now more likely to access online based video resources
        for information and advice on how to help their symptoms and health related quality of life
        using smart phones and tablets 2. During the Covid-19 pandemic many healthcare services,
        patient support groups and individuals living with chronic diseases produced video content
        that is freely accessible online 4. A recent project by the IPCRG to curate evidence-based
        video resources into a digital magazine discovered that content quality varied vastly and
        gaps in resources still remained 5. With the growing use of online video resources there is a
        need to establish what video resources need to have in terms of content, quality and personal
        appeal for people living with COPD to successfully use at aid self-management 6,7. The
        digital magazine was created with the understanding that it would be accessible to those who
        were not digitally excluded and appeal to those who had adequate digital literacy skills,
        however there are people with COPD who are digitally excluded and have varying degrees of
        digital literacy skills 8,9. The magazine format was chosen to provide a recognisable and
        easily navigated format however, it is not clear what formats, access and literacy levels are
        necessary to support the use of online video resources, in particular this digital
        magazine-based collation of videos 8.
  
        The aims of this study are to
  
          1. evaluate the use of the digital magazine format with video self-management content from
             an end user perspective, including
  
               1. what characteristics a good video resource should have
  
               2. what information is important to people with COPD to include in videos and digital
                  magazines,
  
               3. the useability of a digital magazine format
  
          2. Explore the opinions, experiences and preferences of people living with COPD for
             accessing online self-management content including barriers and facilitators for
             accessing online self-management video content
  
        3-4 focus groups of ideally 4-8 people with COPD in each group will be conducted to discuss
        the use and make up of online self-management video content and wider experience of using
        online video resources for health information.
  
        People with COPD will be recruited using the networks of those involved in the IPCRG project
        such as UK based support and exercise groups for people with COPD
  
        Once returned, participants will be booked into online or face to face focus groups of around
        4-8 people. Prior to attending to the focus groups, participants will be (1) asked to
        complete an eHEALS measure of digital literacy either over the phone with a researcher or
        return an electronic copy and (2) they will be requested to review a digital magazine.
  
        The focus group will be facilitated by a researcher with experience in respiratory
        rehabilitation who has not been involved in developing the digital magazine based on a topic
        guide developed using extant literature and steering group discussions.
  
        Focus groups would be transcribed verbatim and analysed by a steering group member with
        experience in respiratory rehabilitation and the researcher who facilitated the focus groups
        separately using NVivo software and an inductive thematic analysis approach 10. Themes will
        be discussed with a further researcher and finalised by consensus
  observational model: Other
  time perspective: Cross-Sectional
  measure: Qualitative data
  time frame: baseline
  description: Focus group transcripts
  measure: eHEALS questionnaire
  time frame: baseline
  description: Questionnaire about confidence finding and using electronic based health information
  intervention type: Other
  intervention name: No intervention
  description: No intervention studied
  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: Kirsti J Loughran, PhD
  phone: 07385086743
  email: k.loughran@tees.ac.uk
  last name: Laura Cordova-Rivera, PhD
  email: l.cordovarivera@tees.ac.uk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: Teesside University
  investigator full name: Kirsti Loughran
  investigator title: Research Fellow
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive
  sharing ipd: No