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/NCT06024655</url>
    </required_header>
    <id_info>
      <org_study_id>22IC7495</org_study_id>
      <nct_id>NCT06024655</nct_id>
    </id_info>
    <brief_title>Qualitative Study to Determine How Chronic Kidney Disease is Managed by Healthcare Professionals in Primary Care</brief_title>
    <official_title>Qualitative Study to Determine How Chronic Kidney Disease is Managed by Healthcare Professionals in Primary Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Imperial College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Imperial College London</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 prevalence of Chronic Kidney Disease is rising worldwide exponentially on account of a&#xD;
        rising prevalence of the commonest causes of patients developing CKD. For instance, the&#xD;
        prevalence of Type 2 diabetes, the commonest cause of CKD worldwide, is increasing with an&#xD;
        expected 450 million people expected to have type 2 diabetes by 2030. Poorly controlled blood&#xD;
        sugars are associated with a risk of complications related to the eyes, heart and kidneys&#xD;
        amongst other organs, resulting in poor long-term health and quality of life. The kidney is&#xD;
        one of the most frequently affected organs, with diabetes related kidney disease (DKD) the&#xD;
        commonest cause of kidney failure worldwide, with patients requiring dialysis and&#xD;
        transplantation to survive. However, despite transplantation allowing patients to live life's&#xD;
        without the need for dialysis, diabetes remains to be associated with poor transplant&#xD;
        function, cardiovascular disease and overall poor quality of life. With primary care being&#xD;
        instrumental in the screening, diagnosis and management/monitoring of CKD, this study aims to&#xD;
        identify areas done well as well as areas where improvement is needed to improve a patients&#xD;
        clinical journey and management. This will be done in the form of an online questionnaire and&#xD;
        focus groups, advertised via clinical commissioning groups across the United Kingdom. Through&#xD;
        this, the investigators hope to gain further insight into areas of clinical management done&#xD;
        well and areas of improvement as well as how primary care feel current management could be&#xD;
        improved upon, obstacles faced, additional resources required and how they could be better&#xD;
        supported by hospital specialists. Study results will be analysed and published in a peer&#xD;
        reviewed journal with recommendations made with regards to how care should be altered to help&#xD;
        delay and prevent CKD onset and progression.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is designed in the form of a clinician validated online questionnaire (conducted&#xD;
        via Qualitrics.com), with participants recruited anonymously. Integrated care boards (ICB)&#xD;
        from across the country will be sent an online link to the questionnaire via email and&#xD;
        encouraged to share amongst clinicians and allied health care providers within their ICB.&#xD;
        Where participants open the study web address (via an anonymous link or QR code) they will be&#xD;
        taken to the participant information sheet which aims to provide potential participants with&#xD;
        more information regarding the study, its aims, benefits, risks and potential conflicts of&#xD;
        interests. Participants will then be asked to consent to the study online following which&#xD;
        they will be asked to complete an online questionnaire, which aims to take participants no&#xD;
        more than fifteen minutes to complete. As an added non obligatory component, participants who&#xD;
        complete the study, will be asked if they are willing to partake in an online focus group of&#xD;
        uptown 6 participants in the future, to further discuss the study and gain a further&#xD;
        understanding of factors which would empower participants to improve their individual health&#xD;
        and diabetes control. Those participants will be asked to provide a contact email address, in&#xD;
        order for the study organisers to make contact with the participant with regards to potential&#xD;
        focus groups in the future. Participation is completely voluntary and participants may change&#xD;
        their decision at any time. Participants will be consented again for their participation in&#xD;
        the focus groups electronically prior to the focus group.Focus groups will be conducted via&#xD;
        Microsoft Teams and will concentrate on key findings of the online questionnaire data to&#xD;
        further understand clinician perspectives of how diabetes is currently managed and ways in&#xD;
        which care could be improved upon. They will be of no longer than 60 minutes in duration&#xD;
        each.&#xD;
  &#xD;
        Focus groups will be audio recorded and be transcribed by the study organisers within 7 days&#xD;
        of the focus group, following which the recording will be deleted. Transcribed focus groups&#xD;
        will be anonymised and will be stored electronically at Imperial College London in a password&#xD;
        protected file. Data will be analysed and submitted in the form of a research paper to a peer&#xD;
        reviewed scientific journal.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</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>Qualitative review of questionnaire submission and focus groups.</measure>
      <time_frame>6 months</time_frame>
      <description>This is a qualitative study, with qualitative methods applied to analyse the data generated. The qualitative data analysis approach will systematise descriptive data collected through the online questionnaire and subsequent focus groups, with the aim being to identify patterns and themes behind the interviews, surveys, and observations and interpreting it. The method aims to identify patterns and themes behind textual data. Specific analysis undertaken will utilise: 1. Discourse analysis whereby we will review the received answers from the questionnaire and the transcript form the focus groups to determine relationships between the received information and its context. 2. Conversion of qualitative data within the online questionnaire to quantitative data to allow for conclusions to be made 3. Thematic anlaysis for the transcript of the focus group to identify themes on how patients feel their care could have been improved upon.</description>
    </primary_outcome>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Chronic Kidney Diseases</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Health care professional working within the primary health care system, in the United&#xD;
          Kingdom.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Health care professional ( community based - doctor, nurse, healthcare assistant,&#xD;
          pharmacist), working within primary care in the United Kingdom&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Non health care professionals Secondary care health care professionals.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Frederick W K Tam</last_name>
      <role>Principal Investigator</role>
      <affiliation>Imperial College London</affiliation>
    </overall_official>
    <overall_official>
      <last_name>RAKESH DATTANI</last_name>
      <role>Study Chair</role>
      <affiliation>Imperial College London</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hutan Ashrafian</last_name>
      <role>Principal Investigator</role>
      <affiliation>Imperial College London</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>RAKESH DATTANI, MBBS</last_name>
      <phone>020 3313 1000</phone>
      <email>rakesh.dattani@nhs.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Frederick WK Tam</last_name>
      <phone>020 3313 1000</phone>
      <email>f.tam@imperial.ac.uk</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No IPD data to be shared, solely aggregated data.</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>June 1, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT06024655/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06024655
  org study id: 22IC7495
  nct id: NCT06024655
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The prevalence of Chronic Kidney Disease is rising worldwide exponentially on account of a
        rising prevalence of the commonest causes of patients developing CKD. For instance, the
        prevalence of Type 2 diabetes, the commonest cause of CKD worldwide, is increasing with an
        expected 450 million people expected to have type 2 diabetes by 2030. Poorly controlled blood
        sugars are associated with a risk of complications related to the eyes, heart and kidneys
        amongst other organs, resulting in poor long-term health and quality of life. The kidney is
        one of the most frequently affected organs, with diabetes related kidney disease (DKD) the
        commonest cause of kidney failure worldwide, with patients requiring dialysis and
        transplantation to survive. However, despite transplantation allowing patients to live life's
        without the need for dialysis, diabetes remains to be associated with poor transplant
        function, cardiovascular disease and overall poor quality of life. With primary care being
        instrumental in the screening, diagnosis and management/monitoring of CKD, this study aims to
        identify areas done well as well as areas where improvement is needed to improve a patients
        clinical journey and management. This will be done in the form of an online questionnaire and
        focus groups, advertised via clinical commissioning groups across the United Kingdom. Through
        this, the investigators hope to gain further insight into areas of clinical management done
        well and areas of improvement as well as how primary care feel current management could be
        improved upon, obstacles faced, additional resources required and how they could be better
        supported by hospital specialists. Study results will be analysed and published in a peer
        reviewed journal with recommendations made with regards to how care should be altered to help
        delay and prevent CKD onset and progression.
  The study is designed in the form of a clinician validated online questionnaire (conducted
        via Qualitrics.com), with participants recruited anonymously. Integrated care boards (ICB)
        from across the country will be sent an online link to the questionnaire via email and
        encouraged to share amongst clinicians and allied health care providers within their ICB.
        Where participants open the study web address (via an anonymous link or QR code) they will be
        taken to the participant information sheet which aims to provide potential participants with
        more information regarding the study, its aims, benefits, risks and potential conflicts of
        interests. Participants will then be asked to consent to the study online following which
        they will be asked to complete an online questionnaire, which aims to take participants no
        more than fifteen minutes to complete. As an added non obligatory component, participants who
        complete the study, will be asked if they are willing to partake in an online focus group of
        uptown 6 participants in the future, to further discuss the study and gain a further
        understanding of factors which would empower participants to improve their individual health
        and diabetes control. Those participants will be asked to provide a contact email address, in
        order for the study organisers to make contact with the participant with regards to potential
        focus groups in the future. Participation is completely voluntary and participants may change
        their decision at any time. Participants will be consented again for their participation in
        the focus groups electronically prior to the focus group.Focus groups will be conducted via
        Microsoft Teams and will concentrate on key findings of the online questionnaire data to
        further understand clinician perspectives of how diabetes is currently managed and ways in
        which care could be improved upon. They will be of no longer than 60 minutes in duration
        each.
  
        Focus groups will be audio recorded and be transcribed by the study organisers within 7 days
        of the focus group, following which the recording will be deleted. Transcribed focus groups
        will be anonymised and will be stored electronically at Imperial College London in a password
        protected file. Data will be analysed and submitted in the form of a research paper to a peer
        reviewed scientific journal.
  observational model: Cohort
  time perspective: Prospective
  measure: Qualitative review of questionnaire submission and focus groups.
  time frame: 6 months
  description: This is a qualitative study, with qualitative methods applied to analyse the data generated. The qualitative data analysis approach will systematise descriptive data collected through the online questionnaire and subsequent focus groups, with the aim being to identify patterns and themes behind the interviews, surveys, and observations and interpreting it. The method aims to identify patterns and themes behind textual data. Specific analysis undertaken will utilise: 1. Discourse analysis whereby we will review the received answers from the questionnaire and the transcript form the focus groups to determine relationships between the received information and its context. 2. Conversion of qualitative data within the online questionnaire to quantitative data to allow for conclusions to be made 3. Thematic anlaysis for the transcript of the focus group to identify themes on how patients feel their care could have been improved upon.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Frederick W K Tam
  role: Principal Investigator
  affiliation: Imperial College London
  last name: RAKESH DATTANI
  role: Study Chair
  affiliation: Imperial College London
  last name: Hutan Ashrafian
  role: Principal Investigator
  affiliation: Imperial College London
  last name: RAKESH DATTANI, MBBS
  phone: 020 3313 1000
  email: rakesh.dattani@nhs.net
  last name: Frederick WK Tam
  phone: 020 3313 1000
  email: f.tam@imperial.ac.uk
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic
  sharing ipd: No
  ipd description: No IPD data to be shared, solely aggregated data.
  provided document: 