<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/NCT04503811</url>
  </required_header>
  <id_info>
    <org_study_id>AN282540</org_study_id>
    <nct_id>NCT04503811</nct_id>
  </id_info>
  <brief_title>Sense of Control in Frail Older Persons</brief_title>
  <acronym>CONtrol</acronym>
  <official_title>Exploring the Lived Experience of Control and Wellbeing of Older Persons Diagnosed With Frailty Within the Care Service Provision in Southern England</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bournemouth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bournemouth University</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 proposed study seeks to explore the lived experience of control and wellbeing of older&#xD;
      people diagnosed with frailty within the care service provision in southern England.&#xD;
&#xD;
      In the study, the researcher will talk with older people diagnosed with frailty and the&#xD;
      professionals that provide care to them. The researcher is interested in understanding&#xD;
      participants' experiences of a sense of control and how health and social care services&#xD;
      affect this experience.&#xD;
&#xD;
      Although research has shown that rehabilitation can be effective in maintaining physical&#xD;
      activity often frail older people do not wish to take up the rehabilitation services&#xD;
      provided. Research in this area has been dominated by health care professionals' views about&#xD;
      frailty and how services should be provided. Services could be improved by learning from the&#xD;
      first-hand experiences of older people living with frailty and what they feel increases their&#xD;
      level of control and wellbeing within their service use. The factors which increase their&#xD;
      sense of control and wellbeing can then be built into future service development, inform care&#xD;
      policies, and provide new understanding for future research to develop services which are&#xD;
      more attractive and relevant for older frail people.&#xD;
&#xD;
      All persons aged 65 years and over, with a diagnosis of frailty will be eligible to take part&#xD;
      in one to one interviews with the researcher. From the interviews principles underpinning&#xD;
      good practice which enhances the sense of control and wellbeing in older people's lives and&#xD;
      within the services received will be identified. These will be shared with professional care&#xD;
      providers including nurses, doctors, and physiotherapists who routinely work with frail older&#xD;
      people to gain insights into how these principles can be integrated into practice and&#xD;
      developed in policy and future service development. The findings will, therefore, help to&#xD;
      develop services which ensure that they are supportive and increase a sense of control in&#xD;
      life rather than getting in the way of this.&#xD;
&#xD;
      The study is expected to last 12 months and up to 30 participants (20 older people and 10&#xD;
      Hospital staff) will be recruited to take part in the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2021</start_date>
  <completion_date type="Actual">February 21, 2022</completion_date>
  <primary_completion_date type="Actual">February 21, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>How frail older people understand and experience control in their lives and care</measure>
    <time_frame>Up to one and a half hours</time_frame>
    <description>The study will highlight frail older people's experiences, opinions and viewpoints on their sense of control in their lives and care processes and how this impacts on their dignity and well-being.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>How frail older peoples' experiences can be used to shape and enhance care design and delivery.</measure>
    <time_frame>Up to one and a half hours</time_frame>
    <description>The study will aslo highlight how health and social care practices can draw from older people's experiences to inform the design and delivery of care services.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>How professional care providers can integrate into care practice principles that enhance service users' sense of control and well-being.</measure>
    <time_frame>Up to one hour</time_frame>
    <description>The study will help professional care providers working with older people to develop services which ensure that they are supportive and increase a sense of control in life rather than getting in the way of this.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Frailty</condition>
  <condition>Older People</condition>
  <condition>Sense of Control</condition>
  <arm_group>
    <arm_group_label>Frail Older People</arm_group_label>
    <description>The first phase of the data collection process will include one to one interviews with up to twenty (20) frail older people. The pre-selected inclusion criteria for this category of participants include; older people (aged 65 years and over); individuals diagnosed with frailty and receiving (part of their) care services at the Day Hospital; the capacity to give free and fully informed consent; ability to use the English language, as well as judgement by the clinical staff and/or nominated manager that the potential participant can take part in an in-depth interview.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Day Hospital Staff</arm_group_label>
    <description>The second phase of the data collection process will entail one to one interviews with up to ten (10) Staff at the Day Hospital. The study will include staff that routinely work with frail older people at the Day Hospital including nurses (registered and unregistered), doctors, physiotherapists, occupational therapists and therapy assistants that can give free and fully informed consent. Furthermore, the study will include both part-time and full-time staff with a minimum of six months of work experience with frail older people.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study will focus on frail older people and Day Hospital staff that provide care to&#xD;
        them.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Phase one inclusion criteria (frail older people) The pre-selected inclusion criteria for&#xD;
        this category of participants include;&#xD;
&#xD;
          -  older people (aged 65 years and over);&#xD;
&#xD;
          -  individuals diagnosed with frailty and receiving (part of their) care services at the&#xD;
             Day Hospital;&#xD;
&#xD;
          -  the capacity to give free and fully informed consent;&#xD;
&#xD;
          -  ability to use the English language, as well as judgement by the clinical staff and/or&#xD;
             nominated manager that the potential participant can take part in an in-depth&#xD;
             interview.&#xD;
&#xD;
        Phase two inclusion criteria (Hospital staff)&#xD;
&#xD;
          -  The study will include staff that routinely work with frail older people at the Day&#xD;
             Hospital including nurses (registered and unregistered), doctors, physiotherapists,&#xD;
             occupational therapists and therapy assistants that can give free and fully informed&#xD;
             consent.&#xD;
&#xD;
          -  Furthermore, the study will include both part-time and full-time staff with a minimum&#xD;
             of six months of work experience with frail older people.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Phase one exclusion criteria&#xD;
&#xD;
        The exclusion criteria, on the other hand, will include:&#xD;
&#xD;
          -  people who cannot communicate in English;&#xD;
&#xD;
          -  and individuals who are acutely medically unwell.&#xD;
&#xD;
        Phase two exclusion criteria&#xD;
&#xD;
        The second phase of the study will, on the other hand, exclude:&#xD;
&#xD;
        • all staff who do not have routine direct contact with patients' care, for example, the&#xD;
        senior managers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline Ellis-Hill</last_name>
    <role>Study Director</role>
    <affiliation>Chief Investigator/Senior Lecturer In Qualitative Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Dorset NHS Foundation Trust</name>
      <address>
        <city>Bournemouth</city>
        <state>Christchurch</state>
        <zip>BH7 7DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>March 1, 2022</last_update_submitted>
  <last_update_submitted_qc>March 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</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>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The researcher will ensure that the Data is made open and accessible to other researchers in line with the provisions of the InnovateDignity Project Data Management Plan and the Bournemouth University Research Data Policy.&#xD;
Once the study has ended, anonymised data from the project will be deposited in the 'UK Data Archive' in Qualibank for example and QuDEX as a way of ensuring that the data are easily accessible to other researchers in the specific field of study and/or social scientists in related fields such as health care and policy research. However, there will be an embargo of up to 3 years on publications, after which data will be made available and accessible via the UK Data Archive.&#xD;
The data will be secured in line with the UK Data Archive policies and at the end of the project and the three-year embargo, researchers seeking access to the data will have to go through the UK Data Service access processes.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>The data will become available three years after the end of the project.</ipd_time_frame>
    <ipd_access_criteria>The data will be secured in line with the UK Data Archive policies and at the end of the project and the three-year embargo, researchers seeking access to the data will have to go through the UK Data Service access processes.</ipd_access_criteria>
    <ipd_url>http://ukdataservice.ac.uk/</ipd_url>
  </patient_data>
  <!-- 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/NCT04503811
org study id: AN282540
nct id: NCT04503811
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The proposed study seeks to explore the lived experience of control and wellbeing of older
      people diagnosed with frailty within the care service provision in southern England.

      In the study, the researcher will talk with older people diagnosed with frailty and the
      professionals that provide care to them. The researcher is interested in understanding
      participants' experiences of a sense of control and how health and social care services
      affect this experience.

      Although research has shown that rehabilitation can be effective in maintaining physical
      activity often frail older people do not wish to take up the rehabilitation services
      provided. Research in this area has been dominated by health care professionals' views about
      frailty and how services should be provided. Services could be improved by learning from the
      first-hand experiences of older people living with frailty and what they feel increases their
      level of control and wellbeing within their service use. The factors which increase their
      sense of control and wellbeing can then be built into future service development, inform care
      policies, and provide new understanding for future research to develop services which are
      more attractive and relevant for older frail people.

      All persons aged 65 years and over, with a diagnosis of frailty will be eligible to take part
      in one to one interviews with the researcher. From the interviews principles underpinning
      good practice which enhances the sense of control and wellbeing in older people's lives and
      within the services received will be identified. These will be shared with professional care
      providers including nurses, doctors, and physiotherapists who routinely work with frail older
      people to gain insights into how these principles can be integrated into practice and
      developed in policy and future service development. The findings will, therefore, help to
      develop services which ensure that they are supportive and increase a sense of control in
      life rather than getting in the way of this.

      The study is expected to last 12 months and up to 30 participants (20 older people and 10
      Hospital staff) will be recruited to take part in the study.
observational model: Case-Only
time perspective: Other
measure: How frail older people understand and experience control in their lives and care
time frame: Up to one and a half hours
description: The study will highlight frail older people's experiences, opinions and viewpoints on their sense of control in their lives and care processes and how this impacts on their dignity and well-being.
measure: How frail older peoples' experiences can be used to shape and enhance care design and delivery.
time frame: Up to one and a half hours
description: The study will aslo highlight how health and social care practices can draw from older people's experiences to inform the design and delivery of care services.
measure: How professional care providers can integrate into care practice principles that enhance service users' sense of control and well-being.
time frame: Up to one hour
description: The study will help professional care providers working with older people to develop services which ensure that they are supportive and increase a sense of control in life rather than getting in the way of this.
arm group label: Frail Older People
description: The first phase of the data collection process will include one to one interviews with up to twenty (20) frail older people. The pre-selected inclusion criteria for this category of participants include; older people (aged 65 years and over); individuals diagnosed with frailty and receiving (part of their) care services at the Day Hospital; the capacity to give free and fully informed consent; ability to use the English language, as well as judgement by the clinical staff and/or nominated manager that the potential participant can take part in an in-depth interview.
arm group label: Day Hospital Staff
description: The second phase of the data collection process will entail one to one interviews with up to ten (10) Staff at the Day Hospital. The study will include staff that routinely work with frail older people at the Day Hospital including nurses (registered and unregistered), doctors, physiotherapists, occupational therapists and therapy assistants that can give free and fully informed consent. Furthermore, the study will include both part-time and full-time staff with a minimum of six months of work experience with frail older people.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Caroline Ellis-Hill
role: Study Director
affiliation: Chief Investigator/Senior Lecturer In Qualitative Research
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Frailty
sharing ipd: Yes
ipd description: The researcher will ensure that the Data is made open and accessible to other researchers in line with the provisions of the InnovateDignity Project Data Management Plan and the Bournemouth University Research Data Policy.
Once the study has ended, anonymised data from the project will be deposited in the 'UK Data Archive' in Qualibank for example and QuDEX as a way of ensuring that the data are easily accessible to other researchers in the specific field of study and/or social scientists in related fields such as health care and policy research. However, there will be an embargo of up to 3 years on publications, after which data will be made available and accessible via the UK Data Archive.
The data will be secured in line with the UK Data Archive policies and at the end of the project and the three-year embargo, researchers seeking access to the data will have to go through the UK Data Service access processes.
ipd info type: Study Protocol
ipd time frame: The data will become available three years after the end of the project.
ipd access criteria: The data will be secured in line with the UK Data Archive policies and at the end of the project and the three-year embargo, researchers seeking access to the data will have to go through the UK Data Service access processes.
ipd url: http://ukdataservice.ac.uk/