<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/NCT03018951</url>
  </required_header>
  <id_info>
    <org_study_id>REC REF:16 LO 1506</org_study_id>
    <secondary_id>196557</secondary_id>
    <nct_id>NCT03018951</nct_id>
  </id_info>
  <brief_title>Assessing Frailty in Older Adults With Functional Mental Illness</brief_title>
  <official_title>Developing a Tool to Assess Frailty in Older Adults With a Diagnosis of Functional Mental Illness; Tool Development and Pilot Testing.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>South London and Maudsley NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is the development of, and two stages of pilot testing of, a tool&#xD;
      designed to assess frailty in older adults with a diagnosis of a functional mental illness.&#xD;
      During the tool's development stage, participants' input, ideas and feedback will be sought&#xD;
      to inform the tool's design. In the first pilot test the comprehensibility, acceptability and&#xD;
      feasibility of the tool will be established. The tool will be amended based on information&#xD;
      gained in the first pilot test. In the second pilot test the comprehensibility, acceptability&#xD;
      and feasibility of the revised tool will be established. Reliability of the tool will be&#xD;
      explored and preliminary examinations of both the interpretability and construct validity of&#xD;
      the tool will be completed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Questionnaire</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>The primary outcome measure for this study is a questionnaire containing both likert scales and open ended questions designed to obtain feedback from both the participant and rater regarding the comprehensibility, acceptability and feasibility of the newly devised assessment tool designed to assess frailty in older adults with a diagnosis of functional mental illness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraclass Correlation Coefficient and/or Cohen's Kappa (with 95% confidence intervals)</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>The Intraclass Correlation Coefficient and/or Cohen's Kappa (with 95% confidence intervals) of the repeated measures of the revised tool designed to assess frailty in older adults with a diagnosis of functional mental illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The frequency of endorsement per assessment tool item</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>The endorsement frequency for item's of the newly devised tool to assess frailty in older adult populations with a diagnosis of functional mental illness response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of missing/incomplete items</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>The percentage of missing/incomplete items of the newly devised tool to assess frailty in older adult populations with a diagnosis of functional mental illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation coefficient</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Correlation coefficients between scores of the revised tool designed to assess frailty in older adult with a diagnosis of functional mental illness tool and the Tilburg Frailty Indicator</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Frailty</condition>
  <condition>Mental Illness</condition>
  <arm_group>
    <arm_group_label>Tool Development Stage</arm_group_label>
    <description>Older adults aged ≥65 years with a diagnosis of functional mental illness who show some signs of potentially being frail (presence of ≥2 of the following frailty indicators: Aged ≥75 years old, prescribed ≥5 medications, a history of ≥1 fall/s in the 6-month period prior to assessment, admission to hospital in the 6-month period prior to assessment. In receipt of weekly support for Activities of Daily Living (ADL) tasks, In receipt of daily support for Instrumental Activities of Daily Living (IADL) tasks, ≥2 chronic physical health conditions).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pilot Test 1</arm_group_label>
    <description>Older adults aged ≥65 years with a diagnosis of functional mental illness who show some signs of potentially being frail (presence of ≥2 of the following frailty indicators: Aged ≥75 years old, prescribed ≥5 medications, a history of ≥1 fall/s in the 6-month period prior to assessment, admission to hospital in the 6-month period prior to assessment. In receipt of weekly support for Activities of Daily Living (ADL) tasks, In receipt of daily support for Instrumental Activities of Daily Living (IADL) tasks, ≥2 chronic physical health conditions).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pilot Test 2</arm_group_label>
    <description>Older adults aged ≥65 years with a diagnosis of functional mental illness who show some signs of potentially being frail (presence of ≥2 of the following frailty indicators: Aged ≥75 years old, prescribed ≥5 medications, a history of ≥1 fall/s in the 6-month period prior to assessment, admission to hospital in the 6-month period prior to assessment. In receipt of weekly support for Activities of Daily Living (ADL) tasks, In receipt of daily support for Instrumental Activities of Daily Living (IADL) tasks, ≥2 chronic physical health conditions).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tool Development meeting</intervention_name>
    <description>Consenting participants will be invited to attend up to four meetings concerning the design of the specialist tool to assess frailty in older adults with a diagnosis of functional mental illness. The meetings will be small with up to three participants and the Chief Investigator present. The Chief Investigator will present the group with plans and ideas for the proposed assessment tool and facilitate discussions relating to these ideas. Participants will be encouraged to share their opinions and any ideas they may have. The chief investigator will take written meeting minutes during each session, which will be checked and agreed on by all meeting attendees. Each meeting will last no more than 90 minutes.</description>
    <arm_group_label>Tool Development Stage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pilot Test 1 assessment session</intervention_name>
    <description>Consenting participants will engage in a one off assessment session where the newly devised specialist tool to assess frailty in older adults with a diagnosis of functional mental illness will be administered. Participants will be asked a series of verbal questions related to frailty indicators and asked to engage in basic observational tests of walking speed and both static and dynamic balance. Qualitative data will be gathered from the participant to establish the comprehensibility, relevance, acceptability and feasibility of the tool via a questionnaire that includes both Likert scales and open ended questions. To assess the comprehensibility of the tool's questions each participant will also be asked to rephrase a subset of the tools questions. The duration of the assessment session will be 90 minutes maximum.</description>
    <arm_group_label>Pilot Test 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pilot Test 2 assessment session</intervention_name>
    <description>Consenting participants will engage in a one off assessment session where the revised specialist tool to assess frailty in older adults with a diagnosis of functional mental illness will be administered. The administration of the tool will follow the same process as in pilot test 1. Participants will then be asked to complete a further self-rated frailty assessment tool: the Tilburg Frailty Indicator. Again, following the administration of the tools, qualitative data will be gathered from the participant to establish the comprehensibility, relevance, acceptability and feasibility of the revised tool as per the methods in pilot test 1. The tool will be scored by a study researcher and the study's chief investigator at the same time to assess inter-rater reliability. The duration of the assessment session will be 90 minutes maximum.</description>
    <arm_group_label>Pilot Test 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Mental Health care of Older Adult community and inpatient services, South London and the&#xD;
        Maudsley NHS Foundation Trust.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged ≥65 years&#xD;
&#xD;
          -  Diagnosis of one of the following functional mental illnesses; depression, anxiety,&#xD;
             bipolar affective disorder, schizophrenia.&#xD;
&#xD;
          -  Currently in receipt of mental health services under The Care Programme Approach&#xD;
             (CPA).&#xD;
&#xD;
          -  Presence of ≥2 of the following frailty indicators: Aged ≥75 years old, prescribed ≥5&#xD;
             medications, a history of ≥1 fall/s in the 6-month period prior to assessment,&#xD;
             admission to hospital in the 6-month period prior to assessment. In receipt of weekly&#xD;
             support for Activities of Daily Living (ADL) tasks, In receipt of daily support for&#xD;
             Instrumental Activities of Daily Living (IADL) tasks, ≥2 chronic physical health&#xD;
             conditions.&#xD;
&#xD;
          -  Fluent in English language.&#xD;
&#xD;
          -  Able to provide informed consent to engage in the study.&#xD;
&#xD;
          -  Able to tolerate the mental and physical demands of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of a neurodegenerative condition (e.g. mild cognitive impairment or&#xD;
             dementia), neurological condition (e.g. stroke, Parkinson's disease) or head injury&#xD;
             (where a loss of consciousness greater than 10 minutes is reported/recorded).&#xD;
&#xD;
          -  The presence of a severe sensory impairment (e.g. registered blind or deaf).&#xD;
&#xD;
          -  Presence of a developmental intellectual disability.&#xD;
&#xD;
          -  Current alcohol/substance abuse or dependence.&#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>Robert Howard, Professor MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>South London and the Maudsley NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SE5 8AF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Sutton JL, Gould RL, Daley S, Coulson MC, Ward EV, Butler AM, Nunn SP, Howard RJ. Psychometric properties of multicomponent tools designed to assess frailty in older adults: A systematic review. BMC Geriatr. 2016 Feb 29;16:55. doi: 10.1186/s12877-016-0225-2.</citation>
    <PMID>26927924</PMID>
  </reference>
  <reference>
    <citation>Sutton JL, Gould RL, Coulson MC, Ward EV, Butler AM, Smith M, Lavelle G, Rosa A, Langridge M, Howard RJ. Multicomponent Frailty Assessment Tools for Older People with Psychiatric Disorders: A Systematic Review. J Am Geriatr Soc. 2019 May;67(5):1085-1095. doi: 10.1111/jgs.15710. Epub 2018 Dec 27.</citation>
    <PMID>30589075</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 20, 2020</last_update_submitted>
  <last_update_submitted_qc>January 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>frailty, assessement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03018951
org study id: REC REF:16 LO 1506
secondary id: 196557
nct id: NCT03018951
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is the development of, and two stages of pilot testing of, a tool
      designed to assess frailty in older adults with a diagnosis of a functional mental illness.
      During the tool's development stage, participants' input, ideas and feedback will be sought
      to inform the tool's design. In the first pilot test the comprehensibility, acceptability and
      feasibility of the tool will be established. The tool will be amended based on information
      gained in the first pilot test. In the second pilot test the comprehensibility, acceptability
      and feasibility of the revised tool will be established. Reliability of the tool will be
      explored and preliminary examinations of both the interpretability and construct validity of
      the tool will be completed.
observational model: Cohort
time perspective: Cross-Sectional
measure: Questionnaire
time frame: Through study completion, an average of 1 year
description: The primary outcome measure for this study is a questionnaire containing both likert scales and open ended questions designed to obtain feedback from both the participant and rater regarding the comprehensibility, acceptability and feasibility of the newly devised assessment tool designed to assess frailty in older adults with a diagnosis of functional mental illness.
measure: Intraclass Correlation Coefficient and/or Cohen's Kappa (with 95% confidence intervals)
time frame: Through study completion, an average of 1 year
description: The Intraclass Correlation Coefficient and/or Cohen's Kappa (with 95% confidence intervals) of the repeated measures of the revised tool designed to assess frailty in older adults with a diagnosis of functional mental illness.
measure: The frequency of endorsement per assessment tool item
time frame: Through study completion, an average of 1 year
description: The endorsement frequency for item's of the newly devised tool to assess frailty in older adult populations with a diagnosis of functional mental illness response.
measure: Percentage of missing/incomplete items
time frame: Through study completion, an average of 1 year
description: The percentage of missing/incomplete items of the newly devised tool to assess frailty in older adult populations with a diagnosis of functional mental illness.
measure: Correlation coefficient
time frame: Through study completion, an average of 1 year
description: Correlation coefficients between scores of the revised tool designed to assess frailty in older adult with a diagnosis of functional mental illness tool and the Tilburg Frailty Indicator
arm group label: Tool Development Stage
description: Older adults aged ≥65 years with a diagnosis of functional mental illness who show some signs of potentially being frail (presence of ≥2 of the following frailty indicators: Aged ≥75 years old, prescribed ≥5 medications, a history of ≥1 fall/s in the 6-month period prior to assessment, admission to hospital in the 6-month period prior to assessment. In receipt of weekly support for Activities of Daily Living (ADL) tasks, In receipt of daily support for Instrumental Activities of Daily Living (IADL) tasks, ≥2 chronic physical health conditions).
arm group label: Pilot Test 1
description: Older adults aged ≥65 years with a diagnosis of functional mental illness who show some signs of potentially being frail (presence of ≥2 of the following frailty indicators: Aged ≥75 years old, prescribed ≥5 medications, a history of ≥1 fall/s in the 6-month period prior to assessment, admission to hospital in the 6-month period prior to assessment. In receipt of weekly support for Activities of Daily Living (ADL) tasks, In receipt of daily support for Instrumental Activities of Daily Living (IADL) tasks, ≥2 chronic physical health conditions).
arm group label: Pilot Test 2
description: Older adults aged ≥65 years with a diagnosis of functional mental illness who show some signs of potentially being frail (presence of ≥2 of the following frailty indicators: Aged ≥75 years old, prescribed ≥5 medications, a history of ≥1 fall/s in the 6-month period prior to assessment, admission to hospital in the 6-month period prior to assessment. In receipt of weekly support for Activities of Daily Living (ADL) tasks, In receipt of daily support for Instrumental Activities of Daily Living (IADL) tasks, ≥2 chronic physical health conditions).
intervention type: Other
intervention name: Tool Development meeting
description: Consenting participants will be invited to attend up to four meetings concerning the design of the specialist tool to assess frailty in older adults with a diagnosis of functional mental illness. The meetings will be small with up to three participants and the Chief Investigator present. The Chief Investigator will present the group with plans and ideas for the proposed assessment tool and facilitate discussions relating to these ideas. Participants will be encouraged to share their opinions and any ideas they may have. The chief investigator will take written meeting minutes during each session, which will be checked and agreed on by all meeting attendees. Each meeting will last no more than 90 minutes.
arm group label: Tool Development Stage
intervention type: Other
intervention name: Pilot Test 1 assessment session
description: Consenting participants will engage in a one off assessment session where the newly devised specialist tool to assess frailty in older adults with a diagnosis of functional mental illness will be administered. Participants will be asked a series of verbal questions related to frailty indicators and asked to engage in basic observational tests of walking speed and both static and dynamic balance. Qualitative data will be gathered from the participant to establish the comprehensibility, relevance, acceptability and feasibility of the tool via a questionnaire that includes both Likert scales and open ended questions. To assess the comprehensibility of the tool's questions each participant will also be asked to rephrase a subset of the tools questions. The duration of the assessment session will be 90 minutes maximum.
arm group label: Pilot Test 1
intervention type: Other
intervention name: Pilot Test 2 assessment session
description: Consenting participants will engage in a one off assessment session where the revised specialist tool to assess frailty in older adults with a diagnosis of functional mental illness will be administered. The administration of the tool will follow the same process as in pilot test 1. Participants will then be asked to complete a further self-rated frailty assessment tool: the Tilburg Frailty Indicator. Again, following the administration of the tools, qualitative data will be gathered from the participant to establish the comprehensibility, relevance, acceptability and feasibility of the revised tool as per the methods in pilot test 1. The tool will be scored by a study researcher and the study's chief investigator at the same time to assess inter-rater reliability. The duration of the assessment session will be 90 minutes maximum.
arm group label: Pilot Test 2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Howard, Professor MD
role: Principal Investigator
affiliation: King's College London
facility: 
country: United Kingdom
citation: Sutton JL, Gould RL, Daley S, Coulson MC, Ward EV, Butler AM, Nunn SP, Howard RJ. Psychometric properties of multicomponent tools designed to assess frailty in older adults: A systematic review. BMC Geriatr. 2016 Feb 29;16:55. doi: 10.1186/s12877-016-0225-2.
PMID: 26927924
citation: Sutton JL, Gould RL, Coulson MC, Ward EV, Butler AM, Smith M, Lavelle G, Rosa A, Langridge M, Howard RJ. Multicomponent Frailty Assessment Tools for Older People with Psychiatric Disorders: A Systematic Review. J Am Geriatr Soc. 2019 May;67(5):1085-1095. doi: 10.1111/jgs.15710. Epub 2018 Dec 27.
PMID: 30589075
responsible party type: Sponsor
mesh term: Frailty
mesh term: Mental Disorders
sharing ipd: No