<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/NCT03308123</url>
  </required_header>
  <id_info>
    <org_study_id>15/EE/0007</org_study_id>
    <secondary_id>DTC-RP-PG-0311-12004</secondary_id>
    <nct_id>NCT03308123</nct_id>
  </id_info>
  <brief_title>PERFECTED: Caring for Patients With Hip-fracture &amp; Memory Difficulties</brief_title>
  <acronym>PERFECTED</acronym>
  <official_title>PERFECTED WP1 P4: A Qualitative Exploration of Lay and Professional Stakeholder Views of Care Delivery in Hospitals for Patients With Hip-fracture &amp; Memory Difficulties</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of East Anglia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of East Anglia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This qualitative study is part of the 5-year long (2013-18) PERFECTED (Peri-operative&#xD;
      Enhanced Recovery hip-fracture Care of paTiEnts with Dementia) National Institute for Health&#xD;
      Research (NIHR) funded research programme. PERFECTED's overall aim is to develop and pilot an&#xD;
      evidence-based intervention to improve the hospital care of patients living with dementia who&#xD;
      have fractured their hip. The findings from this particular study will support PERFECTED's&#xD;
      other activities by exploring stakeholder (lay and professional) views of the hospital care&#xD;
      experiences of hip-fracture patients who are experiencing memory difficulties. Best practices&#xD;
      and priorities, including attention to cost-consequences will be explored.&#xD;
&#xD;
      Semi-structured interviews will be conducted with 15-30 hip-fracture patients with mild&#xD;
      memory difficulties recently discharged from acute hospitals in Norwich, Nottingham and&#xD;
      Bradford. Equal attention will be given to those patients discharged directly home and those&#xD;
      discharged to community hospitals for further rehabilitation. Interviews will be conducted&#xD;
      with 15-30 recognised carers of hip-fracture patients with moderate/severe memory&#xD;
      difficulties who have recently been discharged from acute hospitals in the same three&#xD;
      regions. Semi-structured interviews will also be carried out with a nominated dementia lead&#xD;
      in each region. Finally, in each region, small focus groups, face-to-face or telephone&#xD;
      interviews will be conducted, with clinical staff of various grades and professions, hospital&#xD;
      managers and with NHS commissioners. This study will enable a range of topics and&#xD;
      perspectives to be explored and potential components for PERFECTED's intervention to be&#xD;
      identified.&#xD;
&#xD;
      As part of PERFECTED's on-going commitment to Public Patient Involvement (PPI), lay&#xD;
      researchers will be trained to assist in interviewing recognised carers of hip-fracture&#xD;
      patients with moderate/severe memory difficulties. Interviews and focus groups will be&#xD;
      recorded, transcribed and analysed thematically. Resulting data will address the pre-defined&#xD;
      aims of the current study and feed into findings reported across the whole of Work Package 1&#xD;
      of PERFECTED.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2015</start_date>
  <completion_date type="Actual">February 22, 2016</completion_date>
  <primary_completion_date type="Actual">July 1, 2015</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Semi-Structure Interview</measure>
    <time_frame>1 month</time_frame>
    <description>Stakeholder experiences</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">52</enrollment>
  <condition>Dementia</condition>
  <condition>Hip Fractures</condition>
  <arm_group>
    <arm_group_label>Health Care Professionals</arm_group_label>
    <description>Health care professionals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carers of hip-fracture patients with moderate/severe</arm_group_label>
    <description>Carers of hip-fracture patients with moderate/severe</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Discharged hip-fracture patient with memory difficulty</arm_group_label>
    <description>Discharged hip-fracture patient with memory difficulty</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational study, not interventional</intervention_name>
    <description>Not an intervention study</description>
    <arm_group_label>Carers of hip-fracture patients with moderate/severe</arm_group_label>
    <arm_group_label>Discharged hip-fracture patient with memory difficulty</arm_group_label>
    <arm_group_label>Health Care Professionals</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Recently discharged (within a month) hip-fracture patients with mild memory difficulties&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A hip-fracture patient recently discharged (within a month) from an acute hospital in&#xD;
             one of the study locations.&#xD;
&#xD;
          -  60 years or older&#xD;
&#xD;
          -  Having some memory difficulties as recognised by a relevant member of their care team&#xD;
             - supported by an AMT score of 5-8 if required&#xD;
&#xD;
          -  Has the cognitive ability to engage with a research interview as determined by a&#xD;
             relevant member of their care team&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lacks mental capacity&#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_official>
    <last_name>George C Fox</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of East Anglia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of East Anglia</name>
      <address>
        <city>Norwich</city>
        <state>Norfolk</state>
        <zip>NR4 7TJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>October 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</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>Fractures, Bone</mesh_term>
    <mesh_term>Hip Fractures</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/NCT03308123
org study id: 15/EE/0007
secondary id: DTC-RP-PG-0311-12004
nct id: NCT03308123
lead sponsor: 
has dmc: No
This qualitative study is part of the 5-year long (2013-18) PERFECTED (Peri-operative
      Enhanced Recovery hip-fracture Care of paTiEnts with Dementia) National Institute for Health
      Research (NIHR) funded research programme. PERFECTED's overall aim is to develop and pilot an
      evidence-based intervention to improve the hospital care of patients living with dementia who
      have fractured their hip. The findings from this particular study will support PERFECTED's
      other activities by exploring stakeholder (lay and professional) views of the hospital care
      experiences of hip-fracture patients who are experiencing memory difficulties. Best practices
      and priorities, including attention to cost-consequences will be explored.

      Semi-structured interviews will be conducted with 15-30 hip-fracture patients with mild
      memory difficulties recently discharged from acute hospitals in Norwich, Nottingham and
      Bradford. Equal attention will be given to those patients discharged directly home and those
      discharged to community hospitals for further rehabilitation. Interviews will be conducted
      with 15-30 recognised carers of hip-fracture patients with moderate/severe memory
      difficulties who have recently been discharged from acute hospitals in the same three
      regions. Semi-structured interviews will also be carried out with a nominated dementia lead
      in each region. Finally, in each region, small focus groups, face-to-face or telephone
      interviews will be conducted, with clinical staff of various grades and professions, hospital
      managers and with NHS commissioners. This study will enable a range of topics and
      perspectives to be explored and potential components for PERFECTED's intervention to be
      identified.

      As part of PERFECTED's on-going commitment to Public Patient Involvement (PPI), lay
      researchers will be trained to assist in interviewing recognised carers of hip-fracture
      patients with moderate/severe memory difficulties. Interviews and focus groups will be
      recorded, transcribed and analysed thematically. Resulting data will address the pre-defined
      aims of the current study and feed into findings reported across the whole of Work Package 1
      of PERFECTED.
observational model: Other
time perspective: Retrospective
measure: Semi-Structure Interview
time frame: 1 month
description: Stakeholder experiences
arm group label: Health Care Professionals
description: Health care professionals
arm group label: Carers of hip-fracture patients with moderate/severe
description: Carers of hip-fracture patients with moderate/severe
arm group label: Discharged hip-fracture patient with memory difficulty
description: Discharged hip-fracture patient with memory difficulty
intervention type: Other
intervention name: Observational study, not interventional
description: Not an intervention study
arm group label: Carers of hip-fracture patients with moderate/severe
arm group label: Discharged hip-fracture patient with memory difficulty
arm group label: Health Care Professionals
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: George C Fox
role: Principal Investigator
affiliation: University of East Anglia
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Hip Fractures