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/NCT06021704</url>
    </required_header>
    <id_info>
      <org_study_id>2022P001618</org_study_id>
      <nct_id>NCT06021704</nct_id>
    </id_info>
    <brief_title>The Care for America's Aging Study</brief_title>
    <acronym>CfAA</acronym>
    <official_title>Care for America's Aging (CfAA): A Study to Improve Behavioral and Quality of Life Outcomes of Older Adults With Cognitive Impairment and Dementia and Their Care Partners</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Massachusetts General Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        Care for America's Aging is a randomized pilot study investigating whether a home health aide&#xD;
        training intervention consisting of enhanced dementia-specific curriculum content will&#xD;
        improve: 1) behavioral symptoms of older adult persons living with dementia or cognitive&#xD;
        impairment (PLWD/CI) and 2) global health-related quality of life among PLWD/CI and their&#xD;
        care partners.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background and rationale&#xD;
  &#xD;
        There are growing numbers of people affected by cognitive impairment and ADRD (Alzheimer&#xD;
        disease and related dementias). Neuropsychiatric symptoms (NPS) are highly prevalent&#xD;
        throughout the entire trajectory of the ADRD spectrum and represent major sources of&#xD;
        morbidity and distress for patients and their care partners. NPS also predict higher rates of&#xD;
        institutionalization - directly undermining the ability to &quot;age in place&quot;, which is a&#xD;
        critical patient-centered goal for most older adults. Therefore, there is an urgent need for&#xD;
        innovation and development of non-pharmacologic, behavioral interventions to prevent or&#xD;
        mitigate NPS and their adverse consequences for older adults along the ADRD spectrum, and to&#xD;
        provide these interventions in the most-preferred, lowest-cost setting: a person's home.&#xD;
  &#xD;
        As providers of direct care for older adults in their own homes, home health aides (HHAs) are&#xD;
        in a unique position to deliver critical innovations in non-pharmacologic interventions for&#xD;
        ADRD. The on-site support provided by HHAs could help to mitigate or prevent NPS among&#xD;
        persons living with dementia or cognitive impairment (PLWD/CI), while also reducing&#xD;
        caregiving strain for familial care partners. However, there are critical knowledge and care&#xD;
        gaps in non-pharmacologic interventions that leverage the essential workforce of HHAs in&#xD;
        addressing NPS among PLWD/CI and associated care partner distress. It is a priority to ensure&#xD;
        that the knowledge and skill levels of HHAs are adequate to meet the challenges of NPS among&#xD;
        PLWD/CI. While existing care frameworks provide excellent tools for understanding and&#xD;
        responding to NPS, they were not specifically designed to provide HHAs with enhanced&#xD;
        knowledge and skills regarding the full range of NPS or to address specific behavioral&#xD;
        techniques that can support HHAs in real-time with recognizing and responding to challenging&#xD;
        presentations NPS among older PLWD/CI.&#xD;
  &#xD;
        Study design and intervention&#xD;
  &#xD;
        Care for America's Aging is a randomized pilot study of a novel non-pharmacologic&#xD;
        intervention that enhances the knowledge and skills components of home health aide (HHA)&#xD;
        training regarding behavioral symptoms associated with cognitive impairment and dementia&#xD;
        within a currently deployed statewide curriculum for HHA certification.&#xD;
  &#xD;
        The intervention component consists of an enhanced curriculum - an additional 8 hours (2&#xD;
        instructional days) of didactic content and practicum skills training related to recognizing&#xD;
        and responding to dementia-related behaviors - which is delivered in addition to a standard&#xD;
        curriculum of 100 hours (~20 instructional days) of HHA training that currently qualifies HHA&#xD;
        for certificates from the Massachusetts Home Care Aide Council.&#xD;
  &#xD;
        Sixty dyads of homebound older adult patients with cognitive impairment or dementia (ranging&#xD;
        from mild to moderate severity) and their familial care partners will be randomized to&#xD;
        receive care from HHAs who have completed either enhanced or standard curriculum HHA&#xD;
        training. Eligible participants will be assigned by chance (like a coin toss) to one of 2&#xD;
        groups: 1) home care from HHAs who completed enhanced curriculum training or 2) home care&#xD;
        from HHAs who completed standard curriculum training. Therefore, there will be 30&#xD;
        patient-care partner dyads in each of the 2 groups, and each dyad will have an equal chance&#xD;
        of being assigned to either group.&#xD;
  &#xD;
        A block randomization strategy will be used to ensure balance across the 2 groups of patients&#xD;
        who receive their HHA services from public versus private-based home care agencies. This will&#xD;
        ensure that, no matter how many patients receive care from public or private agencies, the&#xD;
        relative proportions of agency type will be balanced across the 2 groups.&#xD;
  &#xD;
        Study outcomes and follow-up&#xD;
  &#xD;
        Participants will complete questionnaires every two weeks over a six-month follow-up period.&#xD;
        Each questionnaire will take about 20 minutes to complete. The questionnaires will ask about&#xD;
        behavioral symptoms, mood, health, and daily functioning; electronic health records will also&#xD;
        be used to collect data regarding patient's health outcomes. Occasionally, participants may&#xD;
        receive a phone call from study staff to collect information or to clarify responses on the&#xD;
        questionnaires.&#xD;
  &#xD;
        This study will test the preliminary efficacy of the HHA enhanced curriculum intervention,&#xD;
        compared to the standard curriculum, for two co-primary outcomes. These co-primary outcomes&#xD;
        are: 1) patient levels of behavioral symptoms; 2) patient and care partner quality of life.&#xD;
        The study will test the benefits of the enhanced curriculum training by comparing outcomes&#xD;
        between dyads receiving services from HHAs with enhanced training and dyads receiving&#xD;
        services from HHAs with standard curriculum training. In addition to these pre-specified&#xD;
        co-primary outcomes, the study will also secondarily address potential benefits of the&#xD;
        enhanced curriculum training on mood, psychosocial, and other behavioral and health outcomes.&#xD;
  &#xD;
        If successful, this pilot study will lay the foundation for further NIH Stage Model research&#xD;
        projects evaluating the enhanced curriculum for HHAs as a novel non-pharmacologic&#xD;
        intervention to optimize behavioral health and well-being for older adults in the Alzheimer&#xD;
        disease and related dementias spectrum and their familial care partners.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">June 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>N=60 dyads of older adult patients with cognitive impairment up to mild-to-moderate ADRD and their familial care partners will be randomly assigned in 1:1 ratio (n=30 dyads per group) to receive home care services from one of 2 pools of HHAs: 1) HHAs who completed enhanced curriculum training or 2) HHAs who completed standard curriculum training. A block randomization strategy will be used to ensure balance of relative proportions of patients who receive HHA services from public versus private-based home care agencies.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Neuropsychiatric Inventory-Questionnaire (NPI-Q)</measure>
      <time_frame>6 Months</time_frame>
      <description>The NPI-Q is a measure of neuropsychiatric symptoms which is completed by caregivers about their patient partners. The questionnaire aims to assess both the presence of symptoms and their severity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient-Reported Outcomes Measurement Information System Global Health 10-item (PROMIS-10)</measure>
      <time_frame>6 months</time_frame>
      <description>The PROMIS-10 measures global health-related quality of life (hrQOL) based on physical, mental, and social functioning.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Cognitive Impairment</condition>
    <condition>Dementia With Behavioral Disturbance</condition>
    <condition>Dementia</condition>
    <condition>Alzheimer Disease</condition>
    <arm_group>
      <arm_group_label>Home Health Aides with Enhanced Curriculum Training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The enhanced curriculum of 108 hours of home health aide (HHA) training will constitute the Experimental arm. This arm consists of the 100 hours of the standard curriculum plus an 8-hour enhanced curriculum that includes additional didactic content and a skills practicum on dementia and recognizing and responding to dementia-related behaviors. As with the standard curriculum, the enhanced curriculum will be delivered by the training entity, CCHERS (Center for Community Health Education, Research and Service, Inc.). The enhanced component is delivered over an additional 2 instructional days (10% increase in instructional days from the standard curriculum).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Home Health Aides with Standard Curriculum Training</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The standard curriculum of 100 hours of home health aide (HHA) training will constitute the No Intervention arm. This 100-hour training is the standard curriculum that has been used by the training entity, CCHERS (Center for Community Health Education, Research and Service, Inc.), for many years to qualify HHAs to receive certificates from the Massachusetts Home Care Aide Council. The standard curriculum includes 75 hours of basic instruction (&quot;ABC's for Direct Care Workers&quot;) and 25 hours of additional content on mental health and dementia topics. The standard curriculum is delivered over approximately on month, or 20 instructional days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Enhanced home health aide training in dementia and dementia-related behaviors</intervention_name>
      <description>8 hours (2 instructional days) of enhanced curriculum dementia-specific instruction for home health aides</description>
      <arm_group_label>Home Health Aides with Enhanced Curriculum Training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria for Patients:&#xD;
  &#xD;
            -  Age 60 years and above&#xD;
  &#xD;
            -  Patients in Mass General Brigham healthcare system&#xD;
  &#xD;
            -  Mild cognitive impairment or dementia diagnosis of no greater than mild-moderate&#xD;
               severity&#xD;
  &#xD;
            -  Discharge plan includes referral to home care services&#xD;
  &#xD;
            -  As all surveys have been validated in English, we will limit participation to&#xD;
               potential participants able to read English.&#xD;
  &#xD;
          Exclusion Criteria for Patients:&#xD;
  &#xD;
            -  Discharge to Medicare short-term rehab only&#xD;
  &#xD;
            -  Lack of care partner&#xD;
  &#xD;
            -  Enrolled in palliative care (projected survival &lt; 6 months)&#xD;
  &#xD;
            -  Clinical severity of dementia that is moderate or greater&#xD;
  &#xD;
            -  Any active clinical issues barring safe participation&#xD;
  &#xD;
            -  Montreal Cognitive Assessment (MoCA)-blind score below cutoff&#xD;
  &#xD;
            -  University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)&#xD;
               score below cutoff&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Olivia I Okereke</last_name>
      <role>Principal Investigator</role>
      <affiliation>Massachusetts General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Olivia I OKEREKE, MD, MS</last_name>
      <phone>(617) 726 - 2000</phone>
      <email>olivia.okereke@mgh.harvard.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mehron PUORIS'HAAG, MD</last_name>
      <phone>(617) 726 - 4381</phone>
      <email>mpuorishaag@mgh.harvard.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Massachusetts General Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02114-2696</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Fraker J, Kales HC, Blazek M, Kavanagh J, Gitlin LN. The role of the occupational therapist in the management of neuropsychiatric symptoms of dementia in clinical settings. Occup Ther Health Care. 2014 Jan;28(1):4-20. doi: 10.3109/07380577.2013.867468.</citation>
      <PMID>24354328</PMID>
    </reference>
    <reference>
      <citation>Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.</citation>
      <PMID>15817019</PMID>
    </reference>
    <reference>
      <citation>Jeste DV, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, Kim K, Meeks T, Kraemer HC. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007 Aug;64(8):966-74. doi: 10.1001/archpsyc.64.8.966.</citation>
      <PMID>17679641</PMID>
    </reference>
    <reference>
      <citation>Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.</citation>
      <PMID>7991117</PMID>
    </reference>
    <reference>
      <citation>Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.</citation>
      <PMID>20685078</PMID>
    </reference>
    <reference>
      <citation>Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3-S11. doi: 10.1097/01.mlr.0000258615.42478.55.</citation>
      <PMID>17443116</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Olivia I.Okereke, MD</investigator_full_name>
      <investigator_title>Physician</investigator_title>
    </responsible_party>
    <keyword>Improving Home Care</keyword>
    <keyword>Enhanced Training for Home Health Aides</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
      <mesh_term>Dementia</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
      <mesh_term>Problem Behavior</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Blinded study design; study group data will be analyzed in the aggregate. No Individual Participant Data available to be shared.</ipd_description>
    </patient_data>
    <!-- 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/NCT06021704
  org study id: 2022P001618
  nct id: NCT06021704
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Care for America's Aging is a randomized pilot study investigating whether a home health aide
        training intervention consisting of enhanced dementia-specific curriculum content will
        improve: 1) behavioral symptoms of older adult persons living with dementia or cognitive
        impairment (PLWD/CI) and 2) global health-related quality of life among PLWD/CI and their
        care partners.
  Background and rationale
  
        There are growing numbers of people affected by cognitive impairment and ADRD (Alzheimer
        disease and related dementias). Neuropsychiatric symptoms (NPS) are highly prevalent
        throughout the entire trajectory of the ADRD spectrum and represent major sources of
        morbidity and distress for patients and their care partners. NPS also predict higher rates of
        institutionalization - directly undermining the ability to "age in place", which is a
        critical patient-centered goal for most older adults. Therefore, there is an urgent need for
        innovation and development of non-pharmacologic, behavioral interventions to prevent or
        mitigate NPS and their adverse consequences for older adults along the ADRD spectrum, and to
        provide these interventions in the most-preferred, lowest-cost setting: a person's home.
  
        As providers of direct care for older adults in their own homes, home health aides (HHAs) are
        in a unique position to deliver critical innovations in non-pharmacologic interventions for
        ADRD. The on-site support provided by HHAs could help to mitigate or prevent NPS among
        persons living with dementia or cognitive impairment (PLWD/CI), while also reducing
        caregiving strain for familial care partners. However, there are critical knowledge and care
        gaps in non-pharmacologic interventions that leverage the essential workforce of HHAs in
        addressing NPS among PLWD/CI and associated care partner distress. It is a priority to ensure
        that the knowledge and skill levels of HHAs are adequate to meet the challenges of NPS among
        PLWD/CI. While existing care frameworks provide excellent tools for understanding and
        responding to NPS, they were not specifically designed to provide HHAs with enhanced
        knowledge and skills regarding the full range of NPS or to address specific behavioral
        techniques that can support HHAs in real-time with recognizing and responding to challenging
        presentations NPS among older PLWD/CI.
  
        Study design and intervention
  
        Care for America's Aging is a randomized pilot study of a novel non-pharmacologic
        intervention that enhances the knowledge and skills components of home health aide (HHA)
        training regarding behavioral symptoms associated with cognitive impairment and dementia
        within a currently deployed statewide curriculum for HHA certification.
  
        The intervention component consists of an enhanced curriculum - an additional 8 hours (2
        instructional days) of didactic content and practicum skills training related to recognizing
        and responding to dementia-related behaviors - which is delivered in addition to a standard
        curriculum of 100 hours (~20 instructional days) of HHA training that currently qualifies HHA
        for certificates from the Massachusetts Home Care Aide Council.
  
        Sixty dyads of homebound older adult patients with cognitive impairment or dementia (ranging
        from mild to moderate severity) and their familial care partners will be randomized to
        receive care from HHAs who have completed either enhanced or standard curriculum HHA
        training. Eligible participants will be assigned by chance (like a coin toss) to one of 2
        groups: 1) home care from HHAs who completed enhanced curriculum training or 2) home care
        from HHAs who completed standard curriculum training. Therefore, there will be 30
        patient-care partner dyads in each of the 2 groups, and each dyad will have an equal chance
        of being assigned to either group.
  
        A block randomization strategy will be used to ensure balance across the 2 groups of patients
        who receive their HHA services from public versus private-based home care agencies. This will
        ensure that, no matter how many patients receive care from public or private agencies, the
        relative proportions of agency type will be balanced across the 2 groups.
  
        Study outcomes and follow-up
  
        Participants will complete questionnaires every two weeks over a six-month follow-up period.
        Each questionnaire will take about 20 minutes to complete. The questionnaires will ask about
        behavioral symptoms, mood, health, and daily functioning; electronic health records will also
        be used to collect data regarding patient's health outcomes. Occasionally, participants may
        receive a phone call from study staff to collect information or to clarify responses on the
        questionnaires.
  
        This study will test the preliminary efficacy of the HHA enhanced curriculum intervention,
        compared to the standard curriculum, for two co-primary outcomes. These co-primary outcomes
        are: 1) patient levels of behavioral symptoms; 2) patient and care partner quality of life.
        The study will test the benefits of the enhanced curriculum training by comparing outcomes
        between dyads receiving services from HHAs with enhanced training and dyads receiving
        services from HHAs with standard curriculum training. In addition to these pre-specified
        co-primary outcomes, the study will also secondarily address potential benefits of the
        enhanced curriculum training on mood, psychosocial, and other behavioral and health outcomes.
  
        If successful, this pilot study will lay the foundation for further NIH Stage Model research
        projects evaluating the enhanced curriculum for HHAs as a novel non-pharmacologic
        intervention to optimize behavioral health and well-being for older adults in the Alzheimer
        disease and related dementias spectrum and their familial care partners.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: N=60 dyads of older adult patients with cognitive impairment up to mild-to-moderate ADRD and their familial care partners will be randomly assigned in 1:1 ratio (n=30 dyads per group) to receive home care services from one of 2 pools of HHAs: 1) HHAs who completed enhanced curriculum training or 2) HHAs who completed standard curriculum training. A block randomization strategy will be used to ensure balance of relative proportions of patients who receive HHA services from public versus private-based home care agencies.
  primary purpose: Health Services Research
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Neuropsychiatric Inventory-Questionnaire (NPI-Q)
  time frame: 6 Months
  description: The NPI-Q is a measure of neuropsychiatric symptoms which is completed by caregivers about their patient partners. The questionnaire aims to assess both the presence of symptoms and their severity.
  measure: Patient-Reported Outcomes Measurement Information System Global Health 10-item (PROMIS-10)
  time frame: 6 months
  description: The PROMIS-10 measures global health-related quality of life (hrQOL) based on physical, mental, and social functioning.
  arm group label: Home Health Aides with Enhanced Curriculum Training
  arm group type: Experimental
  description: The enhanced curriculum of 108 hours of home health aide (HHA) training will constitute the Experimental arm. This arm consists of the 100 hours of the standard curriculum plus an 8-hour enhanced curriculum that includes additional didactic content and a skills practicum on dementia and recognizing and responding to dementia-related behaviors. As with the standard curriculum, the enhanced curriculum will be delivered by the training entity, CCHERS (Center for Community Health Education, Research and Service, Inc.). The enhanced component is delivered over an additional 2 instructional days (10% increase in instructional days from the standard curriculum).
  arm group label: Home Health Aides with Standard Curriculum Training
  arm group type: No Intervention
  description: The standard curriculum of 100 hours of home health aide (HHA) training will constitute the No Intervention arm. This 100-hour training is the standard curriculum that has been used by the training entity, CCHERS (Center for Community Health Education, Research and Service, Inc.), for many years to qualify HHAs to receive certificates from the Massachusetts Home Care Aide Council. The standard curriculum includes 75 hours of basic instruction ("ABC's for Direct Care Workers") and 25 hours of additional content on mental health and dementia topics. The standard curriculum is delivered over approximately on month, or 20 instructional days.
  intervention type: Behavioral
  intervention name: Enhanced home health aide training in dementia and dementia-related behaviors
  description: 8 hours (2 instructional days) of enhanced curriculum dementia-specific instruction for home health aides
  arm group label: Home Health Aides with Enhanced Curriculum Training
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Olivia I Okereke
  role: Principal Investigator
  affiliation: Massachusetts General Hospital
  last name: Olivia I OKEREKE, MD, MS
  phone: (617) 726 - 2000
  email: olivia.okereke@mgh.harvard.edu
  last name: Mehron PUORIS'HAAG, MD
  phone: (617) 726 - 4381
  email: mpuorishaag@mgh.harvard.edu
  facility: 
  country: United States
  citation: Fraker J, Kales HC, Blazek M, Kavanagh J, Gitlin LN. The role of the occupational therapist in the management of neuropsychiatric symptoms of dementia in clinical settings. Occup Ther Health Care. 2014 Jan;28(1):4-20. doi: 10.3109/07380577.2013.867468.
  PMID: 24354328
  citation: Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
  PMID: 15817019
  citation: Jeste DV, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, Kim K, Meeks T, Kraemer HC. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007 Aug;64(8):966-74. doi: 10.1001/archpsyc.64.8.966.
  PMID: 17679641
  citation: Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.
  PMID: 7991117
  citation: Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
  PMID: 20685078
  citation: Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3-S11. doi: 10.1097/01.mlr.0000258615.42478.55.
  PMID: 17443116
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Olivia I.Okereke, MD
  investigator title: Physician
  mesh term: Alzheimer Disease
  mesh term: Dementia
  mesh term: Cognitive Dysfunction
  mesh term: Problem Behavior
  sharing ipd: No
  ipd description: Blinded study design; study group data will be analyzed in the aggregate. No Individual Participant Data available to be shared.