<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/NCT02216396</url>
  </required_header>
  <id_info>
    <org_study_id>143438</org_study_id>
    <nct_id>NCT02216396</nct_id>
  </id_info>
  <brief_title>A Naturalistic Two-year Cohort Study of Agitation and Quality of Life in Care Homes</brief_title>
  <acronym>MARQUE2</acronym>
  <official_title>MARQUE (Managing Agitation and Quality of Life) Stream 2: A Naturalistic Two-year Cohort Study of Agitation and Quality of Life in Care Homes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      One third of the population, aged over 65, live and will die with dementia. Half of people&#xD;
      with dementia experience symptoms of agitation every month. Symptoms of agitation include&#xD;
      restlessness, pacing, shouting and verbal or physical aggression. Many people with agitation&#xD;
      are admitted to care homes as families find they cannot care for them at home. Within the&#xD;
      care home, staff also often find managing people with agitation difficult and they react in a&#xD;
      wide range of ways. Agitated behaviour takes up staff time and emotional and physical energy&#xD;
      but they do not always know how to respond. This study is one of the streams in an integrated&#xD;
      programme to help tackle agitation in a variety of settings from domestic environments to end&#xD;
      of life.&#xD;
&#xD;
      Our primary hypothesis is that for people with dementia living in care homes, paid carer use&#xD;
      of dysfunctional coping strategies predicts lower quality of life in residents with dementia&#xD;
      and that this is more so at higher levels of agitation.&#xD;
&#xD;
      We will recruit 60-80 care homes (residential or nursing homes). We will identify all&#xD;
      residents with dementia, and the care home manager will approach them and their family&#xD;
      carers. After obtaining informed consent, or advice from personal or nominated consultees for&#xD;
      those lacking capacity, we will ask people with dementia who can answer questions about their&#xD;
      quality of life using the DEMQOL. We will also ask staff and their family carers for those&#xD;
      who have them, to rate the quality of life of the person with dementia using the DEMQOLproxy.&#xD;
      We will ask care home staff other questions about residents with dementia, including about&#xD;
      agitation, using the Cohen-Mansfield Agitation Inventory (CMAI), and the care they receive.&#xD;
      Staff will also answer questions about the ways they cope with caring stresses, using the&#xD;
      COPE. We will measure quality of life and agitation 5 times over 16 months. We will use our&#xD;
      results to test our theory that agitation is an important factor determining residents&#xD;
      quality of life, and that the ways staff cope with stress affect the impact agitation has on&#xD;
      quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research questions What is the relationship between paid carer coping, and agitation and&#xD;
      quality of life in people with dementia living in care homes? What are the economic&#xD;
      implications? What carer, resident and environmental characteristics predict better quality&#xD;
      of life in this group, and should therefore be incorporated into our draft care home&#xD;
      intervention before it is evaluated? Do agitation, quality of life and quality of care&#xD;
      predict death? Primary hypothesis For people with dementia living in care homes, paid carer&#xD;
      use of dysfunctional coping strategies predicts lower quality of life in residents with&#xD;
      dementia and that this is more so at higher levels of agitation.&#xD;
&#xD;
      Methods Setting and sampling We will recruit care homes from across England. Our sampling&#xD;
      frame will encompass all care homes types where people with dementia reside to ensure&#xD;
      external validity and generalisability. We will recruit homes to ensure a representation of&#xD;
      each provider type (voluntary, state and private) care provision (nursing, residential) and&#xD;
      of urban/suburban and rural locations. We already carry out research with: Jewish Care,&#xD;
      Dementia UK, Camden Adult Social Care, Springdene Care Homes group, BUPA Care Homes, Care UK&#xD;
      and Abbey Care. We will also work with DeNDRoN ENRICH project (CC has been involved in North&#xD;
      Thames pilot) and our project care home partners (Jewish Care, BUPA and Barchester) to&#xD;
      recruit care homes. We have discussed with DeNDRoN ENRICH; the network has 389 research-ready&#xD;
      care homes and is growing rapidly; our target is achievable by targeting larger homes&#xD;
      including our collaborators; BUPA, Jewish Care and Barchester. There are around 18,000&#xD;
      English care homes and 80% of residents have dementia (Alzheimer's Society).&#xD;
&#xD;
      Procedures We will seek care home managers' agreement for their care home's inclusion. We&#xD;
      will note refusal, in order to consider external validity and use its predictors in a&#xD;
      sensitivity analysis. In included homes, we will identify through the home care staff which&#xD;
      people cared for have dementia using a carer proxy measure, the Noticeable Problems Checklist&#xD;
      (Levin 1989) if they do not have a known dementia diagnosis. We will do this rather than&#xD;
      screening residents using a cognitive measure, as it will not cause distress and is&#xD;
      independent of culture and education. We will invite all people with dementia to participate.&#xD;
      Some will be able to give informed consent to take part, but the majority are unlikely to&#xD;
      have capacity to do so. We will follow the Mental Capacity Act (2005) provisions when&#xD;
      deciding whether to include people with dementia who do not have capacity, and in appointing&#xD;
      professional consultees for those without a personal consultee as we have in previous&#xD;
      studies(Jones et al. 2012). We will also interview the consenting primary family carer of&#xD;
      each resident included, if they see their relative at least monthly, and all consenting care&#xD;
      team members, who provide hands-on care. This is to understand the coping strategies used by&#xD;
      all who care for them and the impact on residents. We will ask the paid carer working most&#xD;
      closely with each resident with dementia to complete proxy measures. For each home we will&#xD;
      record care home characteristics, including number of residents (in total and with dementia),&#xD;
      staffing: resident ratios, turnover and details of regular home activities. All assessments&#xD;
      will take place at the care home in a private room, for paid carers and residents; family&#xD;
      carers may choose to be interviewed in the care home, in their own home or at UCL.&#xD;
&#xD;
      Measures Clinical research assistants will conduct interviews at baseline, 4, 8, 12 &amp; 16&#xD;
      months.&#xD;
&#xD;
      Analysis We will test our hypothesis that paid care teams using more dysfunctional coping&#xD;
      strategies, is associated with people with dementia having a worse subsequent quality of life&#xD;
      (measured using paid carer DEMQOL) and that is more so when their agitation levels are&#xD;
      higher. We will take into account the influence of agitation and other predefined carer and&#xD;
      resident environmental characteristics (e.g. specialist dementia home; nursing staff;&#xD;
      dementia severity; resident sex and age). Hierarchical multiple regression models will be&#xD;
      used to allow for the repeated measurements of quality of life over time and clustering by&#xD;
      carer team. Interaction terms will be included in the models to consider differential effects&#xD;
      of baseline agitation levels. We will conduct a cost-consequences analysis, reporting by&#xD;
      different coping strategies the mean per patient resource use and costs, agitation and&#xD;
      quality adjusted life years (QALYs) as measured by the DEMQoL. The net monetary benefit,&#xD;
      calculated as mean per patient costs and QALYs multiplied by the amount a decision maker is&#xD;
      willing to pay for a QALY. Analysis will also be reported by coping strategy. Descriptive&#xD;
      statistics of mean per patient costs and resource use by agitation will also be included and&#xD;
      will follow a predefined Statistical Analysis Plan (SAP). We will obtain date and cause of&#xD;
      death from the ONS mortality data set; the Health and Social Care Information Centre will&#xD;
      obtain this data for us by matching NHS number and date of birth against this database.&#xD;
&#xD;
      Sample size calculation In our START study the correlation between dysfunctional coping and&#xD;
      quality of life was -0.31. To detect this magnitude of correlation with 90% power &amp; 5%&#xD;
      significance requires 105 people with dementia(Machin et al. 2009). Adjustments to allow for&#xD;
      clustering by care team (estimated average team size: 40 people with dementia; Intra cluster&#xD;
      correlation (ICC: 0.075)(Fossey et al. 2006), impact of confounding (Variance Inflation&#xD;
      Factor = 2) [8] &amp; an expected average 2.5 repeated measurements/person (based on 30% drop&#xD;
      out/year) and correlation between repeated quality of life measurements of 0.75 (from START&#xD;
      data) results in a total required sample size of 700. To investigate the interaction between&#xD;
      coping strategy and high and low agitation groups will inflate sample size to 2800. This&#xD;
      sample size will be reduced if cluster size is less than 40 people with dementia; to 1734&#xD;
      people with dementia based on 87 clusters with 20 people with dementia per cluster, or to&#xD;
      2000 people with dementia based on 80 clusters with 25 per cluster, or to 2537 people with&#xD;
      dementia based on 72 clusters with 35 per cluster. Although not powered to show outcome we&#xD;
      will investigate the responses of family carers and people with dementia in sensitivity&#xD;
      analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>DEMQOL and DEMQOL proxy</measure>
    <time_frame>Up to 16 months</time_frame>
    <description>quality of life of the person with dementia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brief COPE (Coping Orientations to Problems Experienced)</measure>
    <time_frame>baseline</time_frame>
    <description>a multidimensional coping inventory that has been widely used to assess the different ways in which people respond to stress, including in nurses (Burgess et al. 2010). It is a self-report questionnaire with fourteen subscales describing different coping strategies, (with two items per scale) (Carver 1997b). We will ask care workers to score each strategy from 1 (not doing it at all) to 4 (doing it a lot). We used three subscales of the COPE for which adequate psychometric properties in dementia carers are reported (Cooper et al. 2008): problem-focussed (active coping, instrumental support and planning), emotion-focussed (acceptance, emotional support, humour, positive reframing and religion) and dysfunctional coping (behavioural disengagement, denial, self distraction, self-blame, substance use and venting).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maslach burnout inventory</measure>
    <time_frame>baseline</time_frame>
    <description>one of the most commonly used measures of burnout in care home staff, and has adequate psychometric properties (Pitfield et al. 2011).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>revised Modified Conflict Tactics Scale for professional carers</measure>
    <time_frame>baseline</time_frame>
    <description>a measure of possibly abusive behaviour staff may use to cope with the stresses of caring and problem behaviours which we have developed and piloted in care home staff in a previous study and have found to be acceptable. The professional carers will complete this questionnaire anonymously and results will not be linked to the rest of the study. We will record whether or not they have completed it in the research records. Staff will complete it in private and post it into a sealed box. We have used this system in the SILQ study successfully. We will record which care home the person completing the form worked in. While we will not be able to identify individual participants, we will notify the care home manager about any concerning abuse happening in the home, specifically if a staff member reports hitting or shaking a resident.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohen-Mansfield Agitation Inventory</measure>
    <time_frame>0,4,8,12,16 months</time_frame>
    <description>most commonly used measure of agitation in people with dementia (Cohen-Mansfield and Billig 1986).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychiatric Inventory</measure>
    <time_frame>0,4,8,12,16 months</time_frame>
    <description>measure of neuropsychiatric symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client service receipt interview</measure>
    <time_frame>0,4,8,12,16 months</time_frame>
    <description>measure of resource use</description>
  </secondary_outcome>
  <other_outcome>
    <measure>EQ-5D proxy</measure>
    <time_frame>0,4,8,12,16 months</time_frame>
    <description>measure of quality of life</description>
  </other_outcome>
  <other_outcome>
    <measure>hospitalisations and date and cause of death</measure>
    <time_frame>up to 16 months</time_frame>
    <description>to be obtained from ONS records via data linkage</description>
  </other_outcome>
  <other_outcome>
    <measure>Therapeutic Environment Screening Survey for Nursing Homes and Residential Care (TESS-NH/RC)</measure>
    <time_frame>0,4,8,12,16 months</time_frame>
    <description>an instrument designed to rate physical environments of facilities, including care homes.</description>
  </other_outcome>
  <enrollment type="Anticipated">1734</enrollment>
  <condition>Dementia</condition>
  <condition>Agitation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        We will recruit care homes from across England. Our sampling frame will encompass all care&#xD;
        homes types where people with dementia reside to ensure external validity and&#xD;
        generalisability. We will recruit homes to ensure a representation of each provider type&#xD;
        (voluntary, state and private) care provision (nursing, residential) and of urban/suburban&#xD;
        and rural locations. There are around 18,000 English care homes and 80% of residents have&#xD;
        dementia (Alzheimer's Society).&#xD;
&#xD;
        We will include all people with dementia diagnosed or screening positive for possible&#xD;
        dementia on the Noticeable Problems checklist, all care home staff who provide care for&#xD;
        this population and family carers who are in regular contact.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        We will seek care home managers' agreement for their care home's inclusion. We will note&#xD;
        refusal, in order to consider external validity and use its predictors in a sensitivity&#xD;
        analysis. In included homes, we will identify through the home care staff which people&#xD;
        cared for have dementia using a carer proxy measure, the Noticeable Problems Checklist&#xD;
        (Levin 1989) if they do not have a known dementia diagnosis. We will do this rather than&#xD;
        screening residents using a cognitive measure, as it will not cause distress and is&#xD;
        independent of culture and education. We will invite all people with dementia to&#xD;
        participate.&#xD;
&#xD;
        We will also interview the consenting primary family carer of each resident included, if&#xD;
        they see their relative at least monthly, and all consenting care team members, who provide&#xD;
        hands-on care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudia Cooper</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Care homes across England</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>December 3, 2015</last_update_submitted>
  <last_update_submitted_qc>December 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dementia</keyword>
  <keyword>care home</keyword>
  <keyword>agitation</keyword>
  <keyword>coping</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Psychomotor Agitation</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/NCT02216396
org study id: 143438
nct id: NCT02216396
lead sponsor: 
has dmc: Yes
One third of the population, aged over 65, live and will die with dementia. Half of people
      with dementia experience symptoms of agitation every month. Symptoms of agitation include
      restlessness, pacing, shouting and verbal or physical aggression. Many people with agitation
      are admitted to care homes as families find they cannot care for them at home. Within the
      care home, staff also often find managing people with agitation difficult and they react in a
      wide range of ways. Agitated behaviour takes up staff time and emotional and physical energy
      but they do not always know how to respond. This study is one of the streams in an integrated
      programme to help tackle agitation in a variety of settings from domestic environments to end
      of life.

      Our primary hypothesis is that for people with dementia living in care homes, paid carer use
      of dysfunctional coping strategies predicts lower quality of life in residents with dementia
      and that this is more so at higher levels of agitation.

      We will recruit 60-80 care homes (residential or nursing homes). We will identify all
      residents with dementia, and the care home manager will approach them and their family
      carers. After obtaining informed consent, or advice from personal or nominated consultees for
      those lacking capacity, we will ask people with dementia who can answer questions about their
      quality of life using the DEMQOL. We will also ask staff and their family carers for those
      who have them, to rate the quality of life of the person with dementia using the DEMQOLproxy.
      We will ask care home staff other questions about residents with dementia, including about
      agitation, using the Cohen-Mansfield Agitation Inventory (CMAI), and the care they receive.
      Staff will also answer questions about the ways they cope with caring stresses, using the
      COPE. We will measure quality of life and agitation 5 times over 16 months. We will use our
      results to test our theory that agitation is an important factor determining residents
      quality of life, and that the ways staff cope with stress affect the impact agitation has on
      quality of life.
Research questions What is the relationship between paid carer coping, and agitation and
      quality of life in people with dementia living in care homes? What are the economic
      implications? What carer, resident and environmental characteristics predict better quality
      of life in this group, and should therefore be incorporated into our draft care home
      intervention before it is evaluated? Do agitation, quality of life and quality of care
      predict death? Primary hypothesis For people with dementia living in care homes, paid carer
      use of dysfunctional coping strategies predicts lower quality of life in residents with
      dementia and that this is more so at higher levels of agitation.

      Methods Setting and sampling We will recruit care homes from across England. Our sampling
      frame will encompass all care homes types where people with dementia reside to ensure
      external validity and generalisability. We will recruit homes to ensure a representation of
      each provider type (voluntary, state and private) care provision (nursing, residential) and
      of urban/suburban and rural locations. We already carry out research with: Jewish Care,
      Dementia UK, Camden Adult Social Care, Springdene Care Homes group, BUPA Care Homes, Care UK
      and Abbey Care. We will also work with DeNDRoN ENRICH project (CC has been involved in North
      Thames pilot) and our project care home partners (Jewish Care, BUPA and Barchester) to
      recruit care homes. We have discussed with DeNDRoN ENRICH; the network has 389 research-ready
      care homes and is growing rapidly; our target is achievable by targeting larger homes
      including our collaborators; BUPA, Jewish Care and Barchester. There are around 18,000
      English care homes and 80% of residents have dementia (Alzheimer's Society).

      Procedures We will seek care home managers' agreement for their care home's inclusion. We
      will note refusal, in order to consider external validity and use its predictors in a
      sensitivity analysis. In included homes, we will identify through the home care staff which
      people cared for have dementia using a carer proxy measure, the Noticeable Problems Checklist
      (Levin 1989) if they do not have a known dementia diagnosis. We will do this rather than
      screening residents using a cognitive measure, as it will not cause distress and is
      independent of culture and education. We will invite all people with dementia to participate.
      Some will be able to give informed consent to take part, but the majority are unlikely to
      have capacity to do so. We will follow the Mental Capacity Act (2005) provisions when
      deciding whether to include people with dementia who do not have capacity, and in appointing
      professional consultees for those without a personal consultee as we have in previous
      studies(Jones et al. 2012). We will also interview the consenting primary family carer of
      each resident included, if they see their relative at least monthly, and all consenting care
      team members, who provide hands-on care. This is to understand the coping strategies used by
      all who care for them and the impact on residents. We will ask the paid carer working most
      closely with each resident with dementia to complete proxy measures. For each home we will
      record care home characteristics, including number of residents (in total and with dementia),
      staffing: resident ratios, turnover and details of regular home activities. All assessments
      will take place at the care home in a private room, for paid carers and residents; family
      carers may choose to be interviewed in the care home, in their own home or at UCL.

      Measures Clinical research assistants will conduct interviews at baseline, 4, 8, 12 & 16
      months.

      Analysis We will test our hypothesis that paid care teams using more dysfunctional coping
      strategies, is associated with people with dementia having a worse subsequent quality of life
      (measured using paid carer DEMQOL) and that is more so when their agitation levels are
      higher. We will take into account the influence of agitation and other predefined carer and
      resident environmental characteristics (e.g. specialist dementia home; nursing staff;
      dementia severity; resident sex and age). Hierarchical multiple regression models will be
      used to allow for the repeated measurements of quality of life over time and clustering by
      carer team. Interaction terms will be included in the models to consider differential effects
      of baseline agitation levels. We will conduct a cost-consequences analysis, reporting by
      different coping strategies the mean per patient resource use and costs, agitation and
      quality adjusted life years (QALYs) as measured by the DEMQoL. The net monetary benefit,
      calculated as mean per patient costs and QALYs multiplied by the amount a decision maker is
      willing to pay for a QALY. Analysis will also be reported by coping strategy. Descriptive
      statistics of mean per patient costs and resource use by agitation will also be included and
      will follow a predefined Statistical Analysis Plan (SAP). We will obtain date and cause of
      death from the ONS mortality data set; the Health and Social Care Information Centre will
      obtain this data for us by matching NHS number and date of birth against this database.

      Sample size calculation In our START study the correlation between dysfunctional coping and
      quality of life was -0.31. To detect this magnitude of correlation with 90% power & 5%
      significance requires 105 people with dementia(Machin et al. 2009). Adjustments to allow for
      clustering by care team (estimated average team size: 40 people with dementia; Intra cluster
      correlation (ICC: 0.075)(Fossey et al. 2006), impact of confounding (Variance Inflation
      Factor = 2) [8] & an expected average 2.5 repeated measurements/person (based on 30% drop
      out/year) and correlation between repeated quality of life measurements of 0.75 (from START
      data) results in a total required sample size of 700. To investigate the interaction between
      coping strategy and high and low agitation groups will inflate sample size to 2800. This
      sample size will be reduced if cluster size is less than 40 people with dementia; to 1734
      people with dementia based on 87 clusters with 20 people with dementia per cluster, or to
      2000 people with dementia based on 80 clusters with 25 per cluster, or to 2537 people with
      dementia based on 72 clusters with 35 per cluster. Although not powered to show outcome we
      will investigate the responses of family carers and people with dementia in sensitivity
      analyses.
observational model: Cohort
time perspective: Prospective
measure: DEMQOL and DEMQOL proxy
time frame: Up to 16 months
description: quality of life of the person with dementia
measure: Brief COPE (Coping Orientations to Problems Experienced)
time frame: baseline
description: a multidimensional coping inventory that has been widely used to assess the different ways in which people respond to stress, including in nurses (Burgess et al. 2010). It is a self-report questionnaire with fourteen subscales describing different coping strategies, (with two items per scale) (Carver 1997b). We will ask care workers to score each strategy from 1 (not doing it at all) to 4 (doing it a lot). We used three subscales of the COPE for which adequate psychometric properties in dementia carers are reported (Cooper et al. 2008): problem-focussed (active coping, instrumental support and planning), emotion-focussed (acceptance, emotional support, humour, positive reframing and religion) and dysfunctional coping (behavioural disengagement, denial, self distraction, self-blame, substance use and venting).
measure: Maslach burnout inventory
time frame: baseline
description: one of the most commonly used measures of burnout in care home staff, and has adequate psychometric properties (Pitfield et al. 2011).
measure: revised Modified Conflict Tactics Scale for professional carers
time frame: baseline
description: a measure of possibly abusive behaviour staff may use to cope with the stresses of caring and problem behaviours which we have developed and piloted in care home staff in a previous study and have found to be acceptable. The professional carers will complete this questionnaire anonymously and results will not be linked to the rest of the study. We will record whether or not they have completed it in the research records. Staff will complete it in private and post it into a sealed box. We have used this system in the SILQ study successfully. We will record which care home the person completing the form worked in. While we will not be able to identify individual participants, we will notify the care home manager about any concerning abuse happening in the home, specifically if a staff member reports hitting or shaking a resident.
measure: Cohen-Mansfield Agitation Inventory
time frame: 0,4,8,12,16 months
description: most commonly used measure of agitation in people with dementia (Cohen-Mansfield and Billig 1986).
measure: Neuropsychiatric Inventory
time frame: 0,4,8,12,16 months
description: measure of neuropsychiatric symptoms
measure: Client service receipt interview
time frame: 0,4,8,12,16 months
description: measure of resource use
measure: EQ-5D proxy
time frame: 0,4,8,12,16 months
description: measure of quality of life
measure: hospitalisations and date and cause of death
time frame: up to 16 months
description: to be obtained from ONS records via data linkage
measure: Therapeutic Environment Screening Survey for Nursing Homes and Residential Care (TESS-NH/RC)
time frame: 0,4,8,12,16 months
description: an instrument designed to rate physical environments of facilities, including care homes.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Claudia Cooper
role: Principal Investigator
affiliation: UCL
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Dementia
mesh term: Psychomotor Agitation