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/NCT06036225</url>
    </required_header>
    <id_info>
      <org_study_id>21081JB-AS</org_study_id>
      <nct_id>NCT06036225</nct_id>
    </id_info>
    <brief_title>PREPARE- Prehabilitation for Patients Awaiting Liver Transplantation: Feasibility and Acceptability Testing.</brief_title>
    <acronym>PREPARE</acronym>
    <official_title>PREhabilitation for Patients Awaiting a Liver Transplantation: The Development and Feasibility Testing of a Remote Multicomponent pREhabilitation Intervention: PREPARE</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Belfast Health and Social Care Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Queen's University, Belfast</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Belfast Health and Social Care 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>
        This is a study developing a prehabilitation intervention and then testing the acceptability&#xD;
        and feasibility of the intervention.&#xD;
  &#xD;
        Start date Aug 2022 for Focus groups and Feb 2023 Co-design workshops and feasibility study&#xD;
        date pending&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is using focus groups and experience based co-design workshops to co-design a&#xD;
        remote multicomponent prehabilitation intervention for patients awaiting liver&#xD;
        transplantation.&#xD;
  &#xD;
        Once the intervention is developed it will then be tested for acceptability and feasibility&#xD;
        with the liver transplantation cohort in Belfast Northern Ireland.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 24, 2022</start_date>
    <completion_date type="Anticipated">September 27, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 24, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Focus groups, experience based co-design and a feasibility study</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment</measure>
      <time_frame>6 months</time_frame>
      <description>It will be presented in percentage form and will be defined by&#xD;
  Number of participants active on the list.&#xD;
  Number of participants eligible to participate.&#xD;
  Number of participants informed about the iPRehab study.&#xD;
  Number of participants who were interested in participating.&#xD;
  Number of participants recruited.&#xD;
  Number of participants interested but didn't recruit and reasons why.&#xD;
  Number of participants who own a computer/phone/tablet.&#xD;
  Number of participants who can use a computer/phone/tablet independently.&#xD;
  Number of participants who need support to use a device. Detail the support required.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adherence</measure>
      <time_frame>6 months</time_frame>
      <description>This will be recorded using percentage and will be defined by&#xD;
  Number of participants who attended 1:1 sessions.&#xD;
  Number of participants who attended the group exercise classes using a class log.&#xD;
  Number of participants who attend the online monthly peer support sessions while active on the liver transplantation waiting list.&#xD;
  Number of participants who accessed the website/web app.&#xD;
  Which sections of the website/web app are utilised and the number of participants who access each section.&#xD;
  Number of participants who wear the activity tracker and report weekly step count.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Retention</measure>
      <time_frame>6 months</time_frame>
      <description>This will be recorded using percentage and will be defined by&#xD;
  Number of participants who completed the baseline assessment.&#xD;
  Number of participants who completed the 12-week iPRehab study.&#xD;
  Number of participants who completed the assessment 1 week post the iPRehab study.&#xD;
  Number of participants who completed the assessment 12 weeks post the iPRehab study.&#xD;
  Number of participants who drop out and the reasons</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability</measure>
      <time_frame>6 months</time_frame>
      <description>This will be measured using an acceptability questionnaire known as Theoretical Framework Acceptability Questionnaire (TFAQ) (Sekhon et al 2022) and followed up with a short interview to understand the extremes of acceptability.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Physical function</measure>
      <time_frame>6 months</time_frame>
      <description>6 minute walk test. This will be recorded in meters covered in the 6 minute duration of the test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frailty</measure>
      <time_frame>6 months</time_frame>
      <description>The Liver frailty index. This index will determine the degree of frailty patients present while awaiting liver transplantation. This scale determines if the patients are frail, pre-frail or robust.&#xD;
  Min score 1 Max Score 7 Higher values indicate a higher degree of frailty.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Liver Transplant</condition>
    <arm_group>
      <arm_group_label>Receiving the prehabilitation intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants will receive the prehabilitation intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Prehabilitation</intervention_name>
      <description>Remote prehabilitation multi-component.</description>
      <arm_group_label>Receiving the prehabilitation intervention</arm_group_label>
      <other_name>Remote prehabilitation</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  on the transplant waiting list&#xD;
  &#xD;
            -  grade 3 below for encephalopathy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  grade 4 above encephalopathy&#xD;
  &#xD;
            -  Known adverse reaction to exercise&#xD;
  &#xD;
            -  New stroke&#xD;
  &#xD;
            -  lacks capacity to consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Roger McCorry, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Belfast HSCT</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Suzanne Lester, PhD</last_name>
      <phone>07825515905</phone>
      <email>slester01@qub.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Judy Bradly, Prof</last_name>
      <email>judy.bradley@qub.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Queen's University Belfast</name>
        <address>
          <city>Belfast</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Judy Bradley, Prof</last_name>
        <email>judy.bradley@qub.ac.uk</email>
      </contact>
      <investigator>
        <last_name>Suzanne Lester, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Roger McCorry, Dr</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>May 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Liver transplant</keyword>
    <keyword>Liver transplantation</keyword>
    <keyword>Prehabilitation</keyword>
    <!-- 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/NCT06036225
  org study id: 21081JB-AS
  nct id: NCT06036225
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a study developing a prehabilitation intervention and then testing the acceptability
        and feasibility of the intervention.
  
        Start date Aug 2022 for Focus groups and Feb 2023 Co-design workshops and feasibility study
        date pending
  This study is using focus groups and experience based co-design workshops to co-design a
        remote multicomponent prehabilitation intervention for patients awaiting liver
        transplantation.
  
        Once the intervention is developed it will then be tested for acceptability and feasibility
        with the liver transplantation cohort in Belfast Northern Ireland.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Focus groups, experience based co-design and a feasibility study
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Recruitment
  time frame: 6 months
  description: It will be presented in percentage form and will be defined by
  Number of participants active on the list.
  Number of participants eligible to participate.
  Number of participants informed about the iPRehab study.
  Number of participants who were interested in participating.
  Number of participants recruited.
  Number of participants interested but didn't recruit and reasons why.
  Number of participants who own a computer/phone/tablet.
  Number of participants who can use a computer/phone/tablet independently.
  Number of participants who need support to use a device. Detail the support required.
  measure: Adherence
  time frame: 6 months
  description: This will be recorded using percentage and will be defined by
  Number of participants who attended 1:1 sessions.
  Number of participants who attended the group exercise classes using a class log.
  Number of participants who attend the online monthly peer support sessions while active on the liver transplantation waiting list.
  Number of participants who accessed the website/web app.
  Which sections of the website/web app are utilised and the number of participants who access each section.
  Number of participants who wear the activity tracker and report weekly step count.
  measure: Retention
  time frame: 6 months
  description: This will be recorded using percentage and will be defined by
  Number of participants who completed the baseline assessment.
  Number of participants who completed the 12-week iPRehab study.
  Number of participants who completed the assessment 1 week post the iPRehab study.
  Number of participants who completed the assessment 12 weeks post the iPRehab study.
  Number of participants who drop out and the reasons
  measure: Acceptability
  time frame: 6 months
  description: This will be measured using an acceptability questionnaire known as Theoretical Framework Acceptability Questionnaire (TFAQ) (Sekhon et al 2022) and followed up with a short interview to understand the extremes of acceptability.
  measure: Physical function
  time frame: 6 months
  description: 6 minute walk test. This will be recorded in meters covered in the 6 minute duration of the test.
  measure: Frailty
  time frame: 6 months
  description: The Liver frailty index. This index will determine the degree of frailty patients present while awaiting liver transplantation. This scale determines if the patients are frail, pre-frail or robust.
  Min score 1 Max Score 7 Higher values indicate a higher degree of frailty.
  arm group label: Receiving the prehabilitation intervention
  arm group type: Experimental
  description: All participants will receive the prehabilitation intervention.
  intervention type: Behavioral
  intervention name: Prehabilitation
  description: Remote prehabilitation multi-component.
  arm group label: Receiving the prehabilitation intervention
  other name: Remote prehabilitation
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Roger McCorry, Dr
  role: Principal Investigator
  affiliation: Belfast HSCT
  last name: Suzanne Lester, PhD
  phone: 07825515905
  email: slester01@qub.ac.uk
  last name: Judy Bradly, Prof
  email: judy.bradley@qub.ac.uk
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor