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/NCT05991726</url>
    </required_header>
    <id_info>
      <org_study_id>33721</org_study_id>
      <nct_id>NCT05991726</nct_id>
    </id_info>
    <brief_title>A Delphi Survey for Key Stakeholders to Identify Priority Self-management Outcomes for Chronic Kidney Disease</brief_title>
    <official_title>Taking an Active Role in Your Own Healthcare: A Delphi Survey for Key Stakeholders to Identify Priority Self-management Outcomes for Chronic Kidney Disease (SM-CKD Delphi Study)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Leicester</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Leicester</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 purpose of this Delphi study is to identify priority outcomes for self-management in&#xD;
        earlier (non-dialysis) stages of CKD from the perspectives of different stakeholder groups in&#xD;
        the UK. The findings of this study will be used to inform outcome measure selection for&#xD;
        research and clinical evaluations of self-management resources and to support implementation,&#xD;
        commissioning and uptake.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic Kidney Disease (CKD) is a progressive condition affecting more than 1.8 million&#xD;
        people in England&#xD;
  &#xD;
        Effective self-management is important for people living with CKD like many Long-Term&#xD;
        Conditions. Self-management in its broadest term can be summarised as individuals&#xD;
        participating in the day-to-day management of their chronic condition&#xD;
  &#xD;
        Theory- and evidence-based tools and resources for self-management education and support are&#xD;
        required to encourage health-promoting behaviours. However, outcomes valued by key&#xD;
        stakeholders are necessary to ensure robust evaluation in research settings and clinical&#xD;
        practice&#xD;
  &#xD;
        A Delphi study is carried out to generate consensus on outcomes that are valued by the&#xD;
        stakeholder groups in this study. The Delphi study will undergo 3-4 survey rounds&#xD;
  &#xD;
        Adult CKD patient participants living in the UK and their significant others were recruited&#xD;
        via social media adverts shared by our research team and English kidney community&#xD;
        organisations. Healthcare professionals, commissioners and policymakers (professional groups)&#xD;
        based in the UK were recruited by direct email invitations to our extensive contacts in the&#xD;
        field&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 5, 2022</start_date>
    <completion_date type="Actual">April 3, 2023</completion_date>
    <primary_completion_date type="Actual">April 3, 2023</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Open ended free text question</measure>
      <time_frame>Between 3 to 6 month</time_frame>
      <description>Round 1- Participants are asked to describe the 3 most important outcomes for self-management in people with non-dialysis CKD from their own perspective or opinion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Consensus Rating</measure>
      <time_frame>Between 3 to 6 month</time_frame>
      <description>Round 2- Participants are asked to rate each item on a 9 point Likert-type scale, the lowest scoring items are removed (consensus is predefined as ≥ 70% on each item scoring on the critical importance scale that is a score of 7-9).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Consensus Ranking</measure>
      <time_frame>Between 3 to 6 month</time_frame>
      <description>Round 3- Participants are asked to rank each item and themes in order from high to low importance to identify the most valued outcomes</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">140</enrollment>
    <condition>Chronic Kidney Diseases</condition>
    <arm_group>
      <arm_group_label>Cohort 1: Professional Expert</arm_group_label>
      <description>This includes Healthcare professionals (HCPs) who look after people with CKD in the UK, anyone involved in designing, developing, managing and commissioning of CKD healthcare in the UK and researchers interested in self-management or CKD</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2: Non-Professional Expert</arm_group_label>
      <description>People living with a diagnosis of CKD. This survey focusses on people with non-dialysis CKD, typically stages 3-4. However, this study does not exclude participation by those at a more advanced stage or receiving renal replacement therapy (dialysis or transplant) as these people also have lived experience of earlier stages to draw on. This will also include 'significant others' whom are supporters or carers of people with CKD such as a family member or a partner of a person with CKD.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Other: Survey</intervention_name>
      <description>Multiple survey rounds identifying most important outcomes for effective self-management for non-dialysis CKD</description>
      <arm_group_label>Cohort 1: Professional Expert</arm_group_label>
      <arm_group_label>Cohort 2: Non-Professional Expert</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          1. People living with CKD. This survey focusses on people with non-dialysis CKD,&#xD;
               typically stages 3-4. However, we will not exclude participation by those at a more&#xD;
               advanced stage or receiving renal replacement therapy (dialysis or transplant) as&#xD;
               these people also have lived experience of earlier stages to draw on.&#xD;
  &#xD;
            2. Carers and Supporters of people with CKD (expected to be a significant other i.e.&#xD;
               spouse or partner, close family member or friend that are involved in the regular care&#xD;
               and support to a person living with CKD)&#xD;
  &#xD;
            3. Healthcare professionals (HCPs) who look after people with CKD in the UK&#xD;
  &#xD;
            4. Anyone involved in designing, developing, managing and commissioning of CKD healthcare&#xD;
               in the UK&#xD;
  &#xD;
            5. Researchers interested in self-management or CKD&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  People with diagnosis of CKD in the UK&#xD;
  &#xD;
            -  Their close family and friend&#xD;
  &#xD;
            -  Healthcare professionals who look after people with CKD in the UK&#xD;
  &#xD;
            -  Anyone involved in designing, developing, managing and commissioning CKD healthcare&#xD;
               services in the UK&#xD;
  &#xD;
            -  Researchers related in a topic related to self-management or CKD&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any participant residing outside of the UK&#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>
    <location>
      <facility>
        <name>University of Leicester</name>
        <address>
          <city>Leicester</city>
          <zip>LE1 7RH</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Survey</keyword>
    <keyword>Chronic Kidney disease</keyword>
    <keyword>Stakeholder</keyword>
    <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>
    <!-- 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/NCT05991726
  org study id: 33721
  nct id: NCT05991726
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this Delphi study is to identify priority outcomes for self-management in
        earlier (non-dialysis) stages of CKD from the perspectives of different stakeholder groups in
        the UK. The findings of this study will be used to inform outcome measure selection for
        research and clinical evaluations of self-management resources and to support implementation,
        commissioning and uptake.
  Chronic Kidney Disease (CKD) is a progressive condition affecting more than 1.8 million
        people in England
  
        Effective self-management is important for people living with CKD like many Long-Term
        Conditions. Self-management in its broadest term can be summarised as individuals
        participating in the day-to-day management of their chronic condition
  
        Theory- and evidence-based tools and resources for self-management education and support are
        required to encourage health-promoting behaviours. However, outcomes valued by key
        stakeholders are necessary to ensure robust evaluation in research settings and clinical
        practice
  
        A Delphi study is carried out to generate consensus on outcomes that are valued by the
        stakeholder groups in this study. The Delphi study will undergo 3-4 survey rounds
  
        Adult CKD patient participants living in the UK and their significant others were recruited
        via social media adverts shared by our research team and English kidney community
        organisations. Healthcare professionals, commissioners and policymakers (professional groups)
        based in the UK were recruited by direct email invitations to our extensive contacts in the
        field
  observational model: Other
  time perspective: Prospective
  measure: Open ended free text question
  time frame: Between 3 to 6 month
  description: Round 1- Participants are asked to describe the 3 most important outcomes for self-management in people with non-dialysis CKD from their own perspective or opinion
  measure: Consensus Rating
  time frame: Between 3 to 6 month
  description: Round 2- Participants are asked to rate each item on a 9 point Likert-type scale, the lowest scoring items are removed (consensus is predefined as ≥ 70% on each item scoring on the critical importance scale that is a score of 7-9).
  measure: Consensus Ranking
  time frame: Between 3 to 6 month
  description: Round 3- Participants are asked to rank each item and themes in order from high to low importance to identify the most valued outcomes
  arm group label: Cohort 1: Professional Expert
  description: This includes Healthcare professionals (HCPs) who look after people with CKD in the UK, anyone involved in designing, developing, managing and commissioning of CKD healthcare in the UK and researchers interested in self-management or CKD
  arm group label: Cohort 2: Non-Professional Expert
  description: People living with a diagnosis of CKD. This survey focusses on people with non-dialysis CKD, typically stages 3-4. However, this study does not exclude participation by those at a more advanced stage or receiving renal replacement therapy (dialysis or transplant) as these people also have lived experience of earlier stages to draw on. This will also include 'significant others' whom are supporters or carers of people with CKD such as a family member or a partner of a person with CKD.
  intervention type: Other
  intervention name: Other: Survey
  description: Multiple survey rounds identifying most important outcomes for effective self-management for non-dialysis CKD
  arm group label: Cohort 1: Professional Expert
  arm group label: Cohort 2: Non-Professional Expert
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic