<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/NCT01671228</url>
  </required_header>
  <id_info>
    <org_study_id>V4_01_JUN_12</org_study_id>
    <secondary_id>SP2/Choices/2012</secondary_id>
    <secondary_id>0171-1</secondary_id>
    <nct_id>NCT01671228</nct_id>
  </id_info>
  <brief_title>Developing and Evaluating the Yorkshire Dialysis Decision Aid</brief_title>
  <acronym>YoDDA</acronym>
  <official_title>Development of a Patient Decision Aid (PtDA) to Facilitate Renal Patients Informed Decisions About Dialysis Treatments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leeds</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kidney Cancer UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Health Service, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baxter Healthcare Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Foundation for Informed Medical Decision Making</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Leeds</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to develop a patient decision aid in paper and web formats to&#xD;
      help patients with chronic kidney disease make informed dialysis treatment decisions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research will develop and evaluate a paper and web resource known as a decision-aid to&#xD;
      help patients make informed decisions about dialysis treatment. The Yorkshire Dialysis&#xD;
      Decision Aid (YoDDA) will help patients' with chronic kidney disease make informed decisions&#xD;
      between haemodialysis and peritoneal dialysis choices by a) re-writing dialysis information&#xD;
      in a more meaningful way for patients, b) restructuring information to make this difficult&#xD;
      decision more manageable, and c) using prompts to help patients imagine the choices'&#xD;
      consequences. The research will assess the acceptability of a patient decision aid in paper&#xD;
      and web versions to patients and their carers, and its impact on patients choices about&#xD;
      dialysis.&#xD;
&#xD;
      The programme of research included:&#xD;
&#xD;
      A survey using qualitative methods of patients with chronic kidney disease and professionals&#xD;
      providing predialysis services to develop the Yorkshire Dialysis Decision Aid content, and&#xD;
      integration within usual predialysis care practices.&#xD;
&#xD;
      A before-and-after study was carried out to evaluate the acceptability of the YoDDA-booklet&#xD;
      to patients with sustained deterioration of kidney function making dialysis decision across&#xD;
      the Yorkshire and Humber region, UK.&#xD;
&#xD;
      An experimental study was carried out on-line to evaluate the acceptability of three versions&#xD;
      of YoDDA-web (YoDDA; YoDDA+values tasks; YoDDA_patient videos) to people, or carers of&#xD;
      people, with kidney disease. The study was advertised with flyers within UK renal units and&#xD;
      notices on the National Kidney Federation's website and members' magazine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preparation for decision making scale</measure>
    <time_frame>one and six weeks after provision information about dialysis choices</time_frame>
    <description>Assesses patient's perception of how useful the resource was in helping patients prepare for a consultation to talk about their health decision (Graham and O'Connor, 2010). http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_PrepDM.pdf</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Usefulness of information</measure>
    <time_frame>one and six weeks after the provision of information</time_frame>
    <description>Study specific items to assess perceived usefulness of information in helping patients understand chronic kidney disease, dialysis treatments and thinking about dialysis</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Dialysis treatment preferences</measure>
    <time_frame>one week and six weeks after the information</time_frame>
    <description>Study specific measure asking patients to rank order their preferred dialysis treatment (CAPD, APD, home HD, centre HD)</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">488</enrollment>
  <condition>Chronic Kidney Failure</condition>
  <arm_group>
    <arm_group_label>decision aid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Yorkshire Dialysis Decision Aid (YoDDA). Delivered as a leaflet in clinic and a web resource outside the NHS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Decision Aid + values task</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Yorkshire Dialysis Decision Aid (YoDDA) + values clarification questions. delivered as a leaflet in clinic and a web-based resource outside the NHS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Decision Aid + patient stories</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Yorkshire Dialysis Decision Aid (YoDDA) + patient stories. Delivered as an web-based resource outside the NHS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>usual predialysis education</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The consultations and information usually provided by the predialysis health professionals</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decision Aid</intervention_name>
    <description>The Yorkshire Dialysis Decision Aid (YoDDA) resource in web and paper format</description>
    <arm_group_label>Decision Aid + patient stories</arm_group_label>
    <arm_group_label>Decision Aid + values task</arm_group_label>
    <arm_group_label>decision aid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decision aid + patient stories</intervention_name>
    <description>The Yorkshire dialysis decision aid (YoDDA) plus a set of narratives provided by patients on the treatment options (home and hospital haemodialysis; continuous ambulatory and automated peritoneal dialysis</description>
    <arm_group_label>Decision Aid + patient stories</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decision Aid + values task</intervention_name>
    <description>The Yorkshire Dialysis decision aid (YoDDA) plus a set of questions to help patients explore what aspects of their life important to them about this decision (values clarification)</description>
    <arm_group_label>Decision Aid + values task</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Adult patients with chronic kidney disease and carers of people with&#xD;
        chronic kidney diseae who are making decisions about dialysis treatments.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria: Those not literate in English&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hilary L Bekker, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leeds</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hull and East Yorkshire Hospital Trust</name>
      <address>
        <city>Hull</city>
        <state>East Yorkshire</state>
        <zip>HU3 2JZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheffield Northern General Teaching Hospital</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S57AU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James University Hospital</name>
      <address>
        <city>Leeds</city>
        <state>West Yorkshire</state>
        <zip>LS97TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradford Teaching Hospital</name>
      <address>
        <city>Bradford</city>
        <state>Yorkshire</state>
        <zip>BD5 0NA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>York teaching Hospital NHS Foundation trust</name>
      <address>
        <city>York</city>
        <state>Yorkshire</state>
        <zip>YO31 8HE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Doncaster Royal Infirmary</name>
      <address>
        <city>Doncaster</city>
        <zip>DN2 5LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>April 30, 2014</last_update_submitted>
  <last_update_submitted_qc>April 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Leeds</investigator_affiliation>
    <investigator_full_name>Hilary L Bekker</investigator_full_name>
    <investigator_title>Senior Lecturer in Behavioural Sciences and Chartered Psychologist</investigator_title>
  </responsible_party>
  <keyword>dialysis</keyword>
  <keyword>chronic kidney failure</keyword>
  <keyword>informed choice</keyword>
  <keyword>patient decision making</keyword>
  <keyword>decision aid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <!-- 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/NCT01671228
org study id: V4_01_JUN_12
secondary id: SP2/Choices/2012
secondary id: 0171-1
nct id: NCT01671228
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this research is to develop a patient decision aid in paper and web formats to
      help patients with chronic kidney disease make informed dialysis treatment decisions.
This research will develop and evaluate a paper and web resource known as a decision-aid to
      help patients make informed decisions about dialysis treatment. The Yorkshire Dialysis
      Decision Aid (YoDDA) will help patients' with chronic kidney disease make informed decisions
      between haemodialysis and peritoneal dialysis choices by a) re-writing dialysis information
      in a more meaningful way for patients, b) restructuring information to make this difficult
      decision more manageable, and c) using prompts to help patients imagine the choices'
      consequences. The research will assess the acceptability of a patient decision aid in paper
      and web versions to patients and their carers, and its impact on patients choices about
      dialysis.

      The programme of research included:

      A survey using qualitative methods of patients with chronic kidney disease and professionals
      providing predialysis services to develop the Yorkshire Dialysis Decision Aid content, and
      integration within usual predialysis care practices.

      A before-and-after study was carried out to evaluate the acceptability of the YoDDA-booklet
      to patients with sustained deterioration of kidney function making dialysis decision across
      the Yorkshire and Humber region, UK.

      An experimental study was carried out on-line to evaluate the acceptability of three versions
      of YoDDA-web (YoDDA; YoDDA+values tasks; YoDDA_patient videos) to people, or carers of
      people, with kidney disease. The study was advertised with flyers within UK renal units and
      notices on the National Kidney Federation's website and members' magazine.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: Preparation for decision making scale
time frame: one and six weeks after provision information about dialysis choices
description: Assesses patient's perception of how useful the resource was in helping patients prepare for a consultation to talk about their health decision (Graham and O'Connor, 2010). http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_PrepDM.pdf
measure: Usefulness of information
time frame: one and six weeks after the provision of information
description: Study specific items to assess perceived usefulness of information in helping patients understand chronic kidney disease, dialysis treatments and thinking about dialysis
measure: Dialysis treatment preferences
time frame: one week and six weeks after the information
description: Study specific measure asking patients to rank order their preferred dialysis treatment (CAPD, APD, home HD, centre HD)
arm group label: decision aid
arm group type: Experimental
description: The Yorkshire Dialysis Decision Aid (YoDDA). Delivered as a leaflet in clinic and a web resource outside the NHS.
arm group label: Decision Aid + values task
arm group type: Experimental
description: The Yorkshire Dialysis Decision Aid (YoDDA) + values clarification questions. delivered as a leaflet in clinic and a web-based resource outside the NHS.
arm group label: Decision Aid + patient stories
arm group type: Experimental
description: The Yorkshire Dialysis Decision Aid (YoDDA) + patient stories. Delivered as an web-based resource outside the NHS.
arm group label: usual predialysis education
arm group type: No Intervention
description: The consultations and information usually provided by the predialysis health professionals
intervention type: Other
intervention name: Decision Aid
description: The Yorkshire Dialysis Decision Aid (YoDDA) resource in web and paper format
arm group label: Decision Aid + patient stories
arm group label: Decision Aid + values task
arm group label: decision aid
intervention type: Other
intervention name: Decision aid + patient stories
description: The Yorkshire dialysis decision aid (YoDDA) plus a set of narratives provided by patients on the treatment options (home and hospital haemodialysis; continuous ambulatory and automated peritoneal dialysis
arm group label: Decision Aid + patient stories
intervention type: Other
intervention name: Decision Aid + values task
description: The Yorkshire Dialysis decision aid (YoDDA) plus a set of questions to help patients explore what aspects of their life important to them about this decision (values clarification)
arm group label: Decision Aid + values task
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hilary L Bekker, PhD
role: Principal Investigator
affiliation: University of Leeds
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Leeds
investigator full name: Hilary L Bekker
investigator title: Senior Lecturer in Behavioural Sciences and Chartered Psychologist
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic