<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/NCT04495686</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-HSR #15372</org_study_id>
    <nct_id>NCT04495686</nct_id>
  </id_info>
  <brief_title>An Innovative Supportive Care Model for Dementia and Traumatic Brain Injury</brief_title>
  <official_title>An Innovative Supportive Care Model for Dementia and Traumatic Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Congressionally Directed Medical Research Programs</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Virginia</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>
      There are an increasing number of people in the U.S. with Alzheimer's disease and other&#xD;
      dementias. Traumatic brain injuries (TBIs) are also common among both civilians and military&#xD;
      personnel, and TBIs increase a person's risk for dementia. Providing care for a person with&#xD;
      dementia is stressful. Dementia caregivers can experience difficulties including stress,&#xD;
      depression, and reduced quality of life. Coordinated dementia care is known to benefit people&#xD;
      with dementia and their caregivers. However, many caregivers do not have access to these&#xD;
      supportive programs.&#xD;
&#xD;
      Our project studies the benefits of telehealth as a new way for caregivers to receive&#xD;
      coordinated dementia care services. We will offer 75 caregivers a 12-month caregiver support&#xD;
      program delivered using telehealth (for example phones, tablets, computers). Caregivers of&#xD;
      both Alzheimer's disease and TBI-related dementia will be included, and the program will be&#xD;
      evaluated for effectiveness in both groups as well as in a control group. The information&#xD;
      from our study will help improve quality of life for caregivers and individuals with&#xD;
      dementia, including military members and Veterans. Our results will also help both civilian&#xD;
      and military health professionals develop effective programs to support families living with&#xD;
      dementia. Policy makers and organizational leaders can use the information to fund programs&#xD;
      that best help families and communities facing dementia and TBI dementia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      More than 150,000 Virginians live with dementia. Most persons with dementia (PWD) are cared&#xD;
      for by an unpaid family caregiver. These caregivers' provision of daily assistance to PWD is&#xD;
      a critical part of the state's dementia care capabilities. Caregivers of PWD experience an&#xD;
      array of negative biopsychosocial impacts related to their caregiving responsibilities that&#xD;
      undermine their own well-being and their care capacity. They are often unprepared to manage&#xD;
      the behavioral symptoms of dementia (BSD); unmanaged symptoms are associated with increased&#xD;
      use of emergency care and institutional placement, which are burdensome outcomes for PWD,&#xD;
      families, and public health systems.&#xD;
&#xD;
      An emergent body of research associates traumatic brain injury (TBI) with increased dementia&#xD;
      risk. Veterans with a history of TBI are therefore at increased risk of developing dementia,&#xD;
      putting their family members at risk for the established negative impacts of caregiving.&#xD;
      Coordinated care programs have proven beneficial for both members of the dementia caregiving&#xD;
      dyad, yet access barriers remain. Many caregivers have competing role responsibilities that&#xD;
      conflict with consistent dementia care access, others are located in rural areas without&#xD;
      access to specialized dementia care.&#xD;
&#xD;
      To surmount access barriers and countervail the negative impacts of caregiving, we propose an&#xD;
      innovative, non-pharmacological intervention: a telehealth-delivered dementia care&#xD;
      coordination program that provides family and caregiver support and will improve the quality&#xD;
      of life (QoL) for both caregivers and PWD. A goal of our project is to fill an existing&#xD;
      service gap by providing coordinated dementia care to an underserved population: caregivers&#xD;
      of persons with TBI dementia.&#xD;
&#xD;
      Our study will test three primary hypotheses: 1) Caregivers of persons with dementia who&#xD;
      participate in the telehealth care coordination program will experience greater improvements&#xD;
      in study caregiver outcomes (depression, burden, reactions to BSD and QoL) than caregivers of&#xD;
      PWD receiving best medical treatment (BMT); 2) Caregivers who participate in the program will&#xD;
      experience greater satisfaction with care than caregivers in the BMT group; 3) The program&#xD;
      will comparable benefits for caregivers of persons with Alzheimer's disease and related&#xD;
      dementia (PWD-ADRD) and persons with TBI dementia (PWD-TBI).&#xD;
&#xD;
      In addition, our study includes three exploratory hypotheses: 1) Certain caregiver&#xD;
      characteristics (external locus of control; lower self-efficacy, sense of hope, and&#xD;
      self-perceived caregiver aptitude) will be negatively associated with improvements in&#xD;
      caregiver study outcomes; 2) Caregivers in the intervention group will experience greater&#xD;
      reductions in emergency/unnecessary health care utilization then caregivers in the BMT group;&#xD;
      3) The intervention will impart sustained caregiver benefits in primary study outcomes.&#xD;
&#xD;
      Project specific aims include: 1) Evaluate the benefits of a telehealth-delivered care&#xD;
      coordination program intervention for caregivers of PWD relative to best medical treatment;&#xD;
      2) Evaluate the impact of the intervention on caregiver satisfaction; 3) Determine the&#xD;
      comparative effectiveness of the care coordination program between caregivers of persons with&#xD;
      ADRD those with TBI dementia; 4) Explore caregiver characteristics that influence&#xD;
      intervention outcomes (burden, depression, QoL, responses to BSD); and 5) Investigate whether&#xD;
      the intervention reduces emergency and unplanned health care utilization.&#xD;
&#xD;
      Our research strategy is a prospective, randomized, unblinded study investigating the&#xD;
      benefits of a 12-month telehealth-delivered dementia care coordination intervention, with&#xD;
      follow up assessments to examine the longevity of the intervention impacts. We will enroll 3&#xD;
      study groups: 50 caregivers of PWD-ADRD receiving the telehealth coordinated care&#xD;
      intervention; 50 caregivers of PWD-ADRD receiving best medical treatment, and 25 caregivers&#xD;
      of PWD-TBI receiving the intervention. We will collect baseline,12-, and 18-month data to&#xD;
      examine intervention effectiveness on caregiver study outcomes and test the prolonged&#xD;
      intervention effects.&#xD;
&#xD;
      Our study uses an innovative telehealth approach to provide care for families living with&#xD;
      dementia. Family support has important implications at the individual, family, community, and&#xD;
      national level. Strategies to reduce caregiver burden and improve QoL for civilian and&#xD;
      military families can lead to greater satisfaction with care and prolong caregivers' capacity&#xD;
      to keep their loved ones at home, reducing burdens on public payment systems, including the&#xD;
      VA. Dissemination of study results will inform state and local policy and finance decisions&#xD;
      that can help improve the lives of the growing population of persons with dementia or TBI&#xD;
      dementia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 3, 2021</start_date>
  <completion_date type="Anticipated">September 2025</completion_date>
  <primary_completion_date type="Anticipated">September 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression: Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)</measure>
    <time_frame>Change outcome measure at Baseline and 12 months and 18 months</time_frame>
    <description>The CESD-R assesses self-reported symptoms of depression. The revised version was developed to reflect current understanding of psychiatric depressive symptoms. The revised 20-item version is highly correlated with the original CESD, demonstrating test validity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Caregiver Burden: Zarit Burden Interview (ZBI)</measure>
    <time_frame>Change outcome measure at Baseline and 12 months and 18 months</time_frame>
    <description>The ZBI is a 22-item caregiver self-report measure assessing degree of caregiver burden in caregivers of PWD. The validated ZBI questions include measures of caregivers' health, finances, social supports, and psychological well-being.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Caregiver Reactions to the Behavioral Symptoms of Dementia: Revised Memory and Behavior Problem Checklist (RMBPC)</measure>
    <time_frame>Change outcome measure at Baseline and 12 months and 18 months</time_frame>
    <description>The RMBPC is a 24-item, caregiver-reported measure that assesses the frequency of problematic behaviors in patients with dementia and the severity of caregivers' reactions to these behaviors. The reliability and validity of the RMBPC have been established.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life: WHO (Five) Well-Being Index (WHO-5)</measure>
    <time_frame>Change outcome measure at Baseline and 12 months and 18 months</time_frame>
    <description>The WHO-5 contains five questions that measure well-being; scores range from 0-25, with higher scores representing higher QoL. The WHO-5 is a validated tool that has been used successfully as an outcome measure in clinical trials across a wide range of study fields.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with Care: Caregiver Satisfaction Survey (CSS)</measure>
    <time_frame>Change outcome measure at 12 months and 18 months</time_frame>
    <description>The CSS is an investigator-developed survey that assesses satisfaction with care services.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Healthcare Resource Utilization: Resource Utilization in Dementia, (RUD) questionnaire version 4.0.</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>The RUD v4.0 is a standardized, widely used instrument to collect resource use data in dementia. Caregivers are asked to report resource utilization for both themselves and the person for whom they are caring.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychiatric Symptoms and Caregiver Reactions: Neuropsychiatric Inventory Questionnaire (NPI-Q).</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>NPI is a validated instrument measuring 12 subdomains of psychopathology (e.g. delusions, agitation/aggression, nighttime behavior) for persons with dementia as assessed by their caregivers. Content and concurrent validity as well as inter-rater and test-retest reliability have been established.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety: Geriatric Anxiety Inventory (GAI).</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>The GAI comprises 20 items that measure self-reported symptoms of anxiety in older adults. The GAI has established internal consistency, test-retest reliability, validity, and sensitivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dementia Knowledge: Dementia Knowledge Assessment Tool Version 2 (DKAT2).</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>The DKAT2 assesses family caregivers' foundational-level knowledge of dementia and covers 2 domains: dementia and its progress, and dementia support and care. The DKAT2's internal consistency, reliability, and content validity have been established.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preparedness for Caregiving: Preparedness for Caregiving Scale (PCS).</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>The PCS is an 8-item self-report instrument that gauges how well caregivers believe they are prepared for multiple domains of caregiving, including providing physical care and emotional support, setting up home-based support services, and handing caregiver stress. The scale's validity and reliability are established.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy: General Self-Efficacy scale (GSE).</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>The GSE is a validated, reliable self-report measure of self-efficacy. Scores on the 10-item scale range from 10-40, with higher scores indicating higher self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optimism/Pessimism: Life-Orientation Test-Revised (LOT-R)</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>The LOT-R is a 10-item test that quantifies optimism. The test has predictive and discriminate validity and can distinguish optimism from constructs such as depression, self-esteem, and self-mastery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basic Activities of Daily Living: Katz Index of Independence in Activities of Daily Living (Katz).</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>The KATZ is a validated measure of function used to objectively evaluate chronically ill and aging populations. The measure ranks overall performances in six functions that indicate independence in 6 basic activities of daily living: bathing, dressing, toileting, transferring, feeding, and continence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Instrumental Activities of Daily Living: Lawton Instrumental Activities of Daily Living Scale (Lawton).</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>The Lawton scale measures a person's level of independence in the completion of instrumental activities of daily living. The validated scale detects functional decline across 8 domains: shopping, food preparation, taking medications, ability to handle finances or use a telephone, laundry, housekeeping, and transportation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life in PWD: Quality of Life in Alzheimer's Disease (QoL-AD).</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>The QoL-AD assesses quality of life reported by older adults with cognitive impairment and their caregivers. The validated 10-minute test has good internal and test-retest reliability. The 13 items were developed based on Lawton's scale for QoL domains and feedback from individuals with dementia and their caregivers.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">171</enrollment>
  <condition>Dementia, Mixed</condition>
  <condition>Dementia Mild</condition>
  <condition>Dementia Moderate</condition>
  <condition>Traumatic Brain Injury</condition>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Caregiver PWD-ADRD TCCI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the Caregiver PWD-ADRD telehealth care coordination intervention (TCCI) group will complete a 12-month telehealth-delivered care coordination program with an assigned dementia care coordinator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caregiver for PWD-ADRD (BMT)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the Caregiver PWD-ADRD best medical treatment (BMT) group will not receive care coordination.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caregiver for PWD-TBI TCCI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the Caregiver PWD-TBI telehealth care coordination intervention (TCCI) group will complete a 12-month telehealth-delivered care coordination program with an assigned dementia care coordinator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caregiver for PWD-TBI (BMT)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the Caregiver PWD-TBI best medical treatment (BMT) group will not receive care coordination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telehealth-delivered Care Coordination Program</intervention_name>
    <description>Participants in the interventional arms of this program will be assigned a Dementia Care Manager (DCM) who will work with caregivers to develop goals and plans that are aimed at providing the best support possible, specific to your needs. These services include supportive counseling, education on dementia, information and referrals to community-based organizations, behavioral symptom management training and assistance with finding available community and government-sponsored programs.&#xD;
DCM's will meet with you at least once monthly and will be available if you need assistance between meetings. At the first meeting, your DCM will explain the questionnaires you will take and how to use the technology in the program. They will then provide a link, via email, where you will download the free teleconferencing software that will be used throughout the program. Questionnaires will then be sent via email invitations through a secure survey platform.</description>
    <arm_group_label>Caregiver PWD-ADRD TCCI</arm_group_label>
    <arm_group_label>Caregiver for PWD-TBI TCCI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Caregiver Inclusion Criteria:&#xD;
&#xD;
          -  Must be at least 18 years of age&#xD;
&#xD;
          -  Self-identified primary caregiver for a community-dwelling patient with dementia (PWD)&#xD;
&#xD;
          -  Must be an unpaid caregiver&#xD;
&#xD;
          -  Basic spoken and written English language skills&#xD;
&#xD;
        Caregiver Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling or unable to fulfill the requirements of the study&#xD;
&#xD;
          -  Any condition which would make the caregiver, in the opinion of the investigator,&#xD;
             unsuitable for the study&#xD;
&#xD;
          -  No access to high-speed/broadband internet service capable of operating study&#xD;
             teleconferencing software available&#xD;
&#xD;
        Patient with Dementia Inclusion Criteria:&#xD;
&#xD;
          -  aged 55 years or older&#xD;
&#xD;
          -  Diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease and related&#xD;
             dementias (ADRD)&#xD;
&#xD;
          -  Mild to moderate dementia, including mixed dementia&#xD;
&#xD;
          -  0-1 appointments in the multi-disciplinary long-term University of Virginia (UVA)&#xD;
             Memory Disorder follow-up clinic (MDC)&#xD;
&#xD;
        Patient with Dementia and TBI Inclusion Criteria:&#xD;
&#xD;
          -  aged 21 years or older&#xD;
&#xD;
          -  Diagnosis of major neurocognitive disorder (MND), mild neurocognitive disorder, or&#xD;
             Alzheimer's disease and related dementias (ADRD)&#xD;
&#xD;
          -  Diagnosis of mild to moderate dementia, including mixed dementia&#xD;
&#xD;
          -  Diagnosed with mild complicated, moderate or sever traumatic brain injury (TBI)&#xD;
&#xD;
          -  TBI event at or after the age of brain maturity, ≥25 years of age&#xD;
&#xD;
        No exclusion criteria for patients with dementia and/or traumatic brain injury.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carol Manning, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia Department of Neurology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>October 11, 2022</last_update_submitted>
  <last_update_submitted_qc>October 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Carol Manning</investigator_full_name>
    <investigator_title>Harrison Distinguished Teaching Professor of Neurology, Vice Chair for Faculty Development, Director Memory Disorders Clinic</investigator_title>
  </responsible_party>
  <keyword>dementia</keyword>
  <keyword>traumatic brain injury</keyword>
  <keyword>caregiver</keyword>
  <keyword>alzheimers</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>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The final dataset will include self-reported demographic information and behavioral data from well-validated questionnaires. Because subjects will be recruited within the University of Virginia Memory and Aging Care Clinic and provided clinical services through this clinic that intersect with their participation in this study, we will be collecting identifying information. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. We are specifically concerned about the potential for negative consequences subsequent to deductive disclosure due to the sensitive nature of the behavioral and diagnostic information being obtained in this study and the potential for these consequences to affect both the study subject and the PWD for whom they provide care.</ipd_description>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>We will make this final research data available by the time of publication of the main findings from the final dataset.</ipd_time_frame>
    <ipd_access_criteria>we will make the final research data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.</ipd_access_criteria>
  </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/NCT04495686
org study id: IRB-HSR #15372
nct id: NCT04495686
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There are an increasing number of people in the U.S. with Alzheimer's disease and other
      dementias. Traumatic brain injuries (TBIs) are also common among both civilians and military
      personnel, and TBIs increase a person's risk for dementia. Providing care for a person with
      dementia is stressful. Dementia caregivers can experience difficulties including stress,
      depression, and reduced quality of life. Coordinated dementia care is known to benefit people
      with dementia and their caregivers. However, many caregivers do not have access to these
      supportive programs.

      Our project studies the benefits of telehealth as a new way for caregivers to receive
      coordinated dementia care services. We will offer 75 caregivers a 12-month caregiver support
      program delivered using telehealth (for example phones, tablets, computers). Caregivers of
      both Alzheimer's disease and TBI-related dementia will be included, and the program will be
      evaluated for effectiveness in both groups as well as in a control group. The information
      from our study will help improve quality of life for caregivers and individuals with
      dementia, including military members and Veterans. Our results will also help both civilian
      and military health professionals develop effective programs to support families living with
      dementia. Policy makers and organizational leaders can use the information to fund programs
      that best help families and communities facing dementia and TBI dementia.
More than 150,000 Virginians live with dementia. Most persons with dementia (PWD) are cared
      for by an unpaid family caregiver. These caregivers' provision of daily assistance to PWD is
      a critical part of the state's dementia care capabilities. Caregivers of PWD experience an
      array of negative biopsychosocial impacts related to their caregiving responsibilities that
      undermine their own well-being and their care capacity. They are often unprepared to manage
      the behavioral symptoms of dementia (BSD); unmanaged symptoms are associated with increased
      use of emergency care and institutional placement, which are burdensome outcomes for PWD,
      families, and public health systems.

      An emergent body of research associates traumatic brain injury (TBI) with increased dementia
      risk. Veterans with a history of TBI are therefore at increased risk of developing dementia,
      putting their family members at risk for the established negative impacts of caregiving.
      Coordinated care programs have proven beneficial for both members of the dementia caregiving
      dyad, yet access barriers remain. Many caregivers have competing role responsibilities that
      conflict with consistent dementia care access, others are located in rural areas without
      access to specialized dementia care.

      To surmount access barriers and countervail the negative impacts of caregiving, we propose an
      innovative, non-pharmacological intervention: a telehealth-delivered dementia care
      coordination program that provides family and caregiver support and will improve the quality
      of life (QoL) for both caregivers and PWD. A goal of our project is to fill an existing
      service gap by providing coordinated dementia care to an underserved population: caregivers
      of persons with TBI dementia.

      Our study will test three primary hypotheses: 1) Caregivers of persons with dementia who
      participate in the telehealth care coordination program will experience greater improvements
      in study caregiver outcomes (depression, burden, reactions to BSD and QoL) than caregivers of
      PWD receiving best medical treatment (BMT); 2) Caregivers who participate in the program will
      experience greater satisfaction with care than caregivers in the BMT group; 3) The program
      will comparable benefits for caregivers of persons with Alzheimer's disease and related
      dementia (PWD-ADRD) and persons with TBI dementia (PWD-TBI).

      In addition, our study includes three exploratory hypotheses: 1) Certain caregiver
      characteristics (external locus of control; lower self-efficacy, sense of hope, and
      self-perceived caregiver aptitude) will be negatively associated with improvements in
      caregiver study outcomes; 2) Caregivers in the intervention group will experience greater
      reductions in emergency/unnecessary health care utilization then caregivers in the BMT group;
      3) The intervention will impart sustained caregiver benefits in primary study outcomes.

      Project specific aims include: 1) Evaluate the benefits of a telehealth-delivered care
      coordination program intervention for caregivers of PWD relative to best medical treatment;
      2) Evaluate the impact of the intervention on caregiver satisfaction; 3) Determine the
      comparative effectiveness of the care coordination program between caregivers of persons with
      ADRD those with TBI dementia; 4) Explore caregiver characteristics that influence
      intervention outcomes (burden, depression, QoL, responses to BSD); and 5) Investigate whether
      the intervention reduces emergency and unplanned health care utilization.

      Our research strategy is a prospective, randomized, unblinded study investigating the
      benefits of a 12-month telehealth-delivered dementia care coordination intervention, with
      follow up assessments to examine the longevity of the intervention impacts. We will enroll 3
      study groups: 50 caregivers of PWD-ADRD receiving the telehealth coordinated care
      intervention; 50 caregivers of PWD-ADRD receiving best medical treatment, and 25 caregivers
      of PWD-TBI receiving the intervention. We will collect baseline,12-, and 18-month data to
      examine intervention effectiveness on caregiver study outcomes and test the prolonged
      intervention effects.

      Our study uses an innovative telehealth approach to provide care for families living with
      dementia. Family support has important implications at the individual, family, community, and
      national level. Strategies to reduce caregiver burden and improve QoL for civilian and
      military families can lead to greater satisfaction with care and prolong caregivers' capacity
      to keep their loved ones at home, reducing burdens on public payment systems, including the
      VA. Dissemination of study results will inform state and local policy and finance decisions
      that can help improve the lives of the growing population of persons with dementia or TBI
      dementia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Depression: Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)
time frame: Change outcome measure at Baseline and 12 months and 18 months
description: The CESD-R assesses self-reported symptoms of depression. The revised version was developed to reflect current understanding of psychiatric depressive symptoms. The revised 20-item version is highly correlated with the original CESD, demonstrating test validity.
measure: Caregiver Burden: Zarit Burden Interview (ZBI)
time frame: Change outcome measure at Baseline and 12 months and 18 months
description: The ZBI is a 22-item caregiver self-report measure assessing degree of caregiver burden in caregivers of PWD. The validated ZBI questions include measures of caregivers' health, finances, social supports, and psychological well-being.
measure: Caregiver Reactions to the Behavioral Symptoms of Dementia: Revised Memory and Behavior Problem Checklist (RMBPC)
time frame: Change outcome measure at Baseline and 12 months and 18 months
description: The RMBPC is a 24-item, caregiver-reported measure that assesses the frequency of problematic behaviors in patients with dementia and the severity of caregivers' reactions to these behaviors. The reliability and validity of the RMBPC have been established.
measure: Quality of Life: WHO (Five) Well-Being Index (WHO-5)
time frame: Change outcome measure at Baseline and 12 months and 18 months
description: The WHO-5 contains five questions that measure well-being; scores range from 0-25, with higher scores representing higher QoL. The WHO-5 is a validated tool that has been used successfully as an outcome measure in clinical trials across a wide range of study fields.
measure: Satisfaction with Care: Caregiver Satisfaction Survey (CSS)
time frame: Change outcome measure at 12 months and 18 months
description: The CSS is an investigator-developed survey that assesses satisfaction with care services.
measure: Healthcare Resource Utilization: Resource Utilization in Dementia, (RUD) questionnaire version 4.0.
time frame: Baseline, 12 months
description: The RUD v4.0 is a standardized, widely used instrument to collect resource use data in dementia. Caregivers are asked to report resource utilization for both themselves and the person for whom they are caring.
measure: Neuropsychiatric Symptoms and Caregiver Reactions: Neuropsychiatric Inventory Questionnaire (NPI-Q).
time frame: Baseline, 12 months
description: NPI is a validated instrument measuring 12 subdomains of psychopathology (e.g. delusions, agitation/aggression, nighttime behavior) for persons with dementia as assessed by their caregivers. Content and concurrent validity as well as inter-rater and test-retest reliability have been established.
measure: Anxiety: Geriatric Anxiety Inventory (GAI).
time frame: Baseline, 12 months
description: The GAI comprises 20 items that measure self-reported symptoms of anxiety in older adults. The GAI has established internal consistency, test-retest reliability, validity, and sensitivity.
measure: Dementia Knowledge: Dementia Knowledge Assessment Tool Version 2 (DKAT2).
time frame: Baseline, 12 months
description: The DKAT2 assesses family caregivers' foundational-level knowledge of dementia and covers 2 domains: dementia and its progress, and dementia support and care. The DKAT2's internal consistency, reliability, and content validity have been established.
measure: Preparedness for Caregiving: Preparedness for Caregiving Scale (PCS).
time frame: Baseline, 12 months
description: The PCS is an 8-item self-report instrument that gauges how well caregivers believe they are prepared for multiple domains of caregiving, including providing physical care and emotional support, setting up home-based support services, and handing caregiver stress. The scale's validity and reliability are established.
measure: Self-Efficacy: General Self-Efficacy scale (GSE).
time frame: Baseline, 12 months
description: The GSE is a validated, reliable self-report measure of self-efficacy. Scores on the 10-item scale range from 10-40, with higher scores indicating higher self-efficacy.
measure: Optimism/Pessimism: Life-Orientation Test-Revised (LOT-R)
time frame: Baseline, 12 months
description: The LOT-R is a 10-item test that quantifies optimism. The test has predictive and discriminate validity and can distinguish optimism from constructs such as depression, self-esteem, and self-mastery.
measure: Basic Activities of Daily Living: Katz Index of Independence in Activities of Daily Living (Katz).
time frame: Baseline, 12 months
description: The KATZ is a validated measure of function used to objectively evaluate chronically ill and aging populations. The measure ranks overall performances in six functions that indicate independence in 6 basic activities of daily living: bathing, dressing, toileting, transferring, feeding, and continence.
measure: Instrumental Activities of Daily Living: Lawton Instrumental Activities of Daily Living Scale (Lawton).
time frame: Baseline, 12 months
description: The Lawton scale measures a person's level of independence in the completion of instrumental activities of daily living. The validated scale detects functional decline across 8 domains: shopping, food preparation, taking medications, ability to handle finances or use a telephone, laundry, housekeeping, and transportation.
measure: Quality of Life in PWD: Quality of Life in Alzheimer's Disease (QoL-AD).
time frame: Baseline, 12 months
description: The QoL-AD assesses quality of life reported by older adults with cognitive impairment and their caregivers. The validated 10-minute test has good internal and test-retest reliability. The 13 items were developed based on Lawton's scale for QoL domains and feedback from individuals with dementia and their caregivers.
arm group label: Caregiver PWD-ADRD TCCI
arm group type: Experimental
description: Participants in the Caregiver PWD-ADRD telehealth care coordination intervention (TCCI) group will complete a 12-month telehealth-delivered care coordination program with an assigned dementia care coordinator.
arm group label: Caregiver for PWD-ADRD (BMT)
arm group type: No Intervention
description: Participants in the Caregiver PWD-ADRD best medical treatment (BMT) group will not receive care coordination.
arm group label: Caregiver for PWD-TBI TCCI
arm group type: Experimental
description: Participants in the Caregiver PWD-TBI telehealth care coordination intervention (TCCI) group will complete a 12-month telehealth-delivered care coordination program with an assigned dementia care coordinator.
arm group label: Caregiver for PWD-TBI (BMT)
arm group type: No Intervention
description: Participants in the Caregiver PWD-TBI best medical treatment (BMT) group will not receive care coordination.
intervention type: Behavioral
intervention name: Telehealth-delivered Care Coordination Program
description: Participants in the interventional arms of this program will be assigned a Dementia Care Manager (DCM) who will work with caregivers to develop goals and plans that are aimed at providing the best support possible, specific to your needs. These services include supportive counseling, education on dementia, information and referrals to community-based organizations, behavioral symptom management training and assistance with finding available community and government-sponsored programs.
DCM's will meet with you at least once monthly and will be available if you need assistance between meetings. At the first meeting, your DCM will explain the questionnaires you will take and how to use the technology in the program. They will then provide a link, via email, where you will download the free teleconferencing software that will be used throughout the program. Questionnaires will then be sent via email invitations through a secure survey platform.
arm group label: Caregiver PWD-ADRD TCCI
arm group label: Caregiver for PWD-TBI TCCI
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Carol Manning, Ph.D.
role: Principal Investigator
affiliation: University of Virginia Department of Neurology
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Carol Manning
investigator title: Harrison Distinguished Teaching Professor of Neurology, Vice Chair for Faculty Development, Director Memory Disorders Clinic
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries
sharing ipd: Yes
ipd description: The final dataset will include self-reported demographic information and behavioral data from well-validated questionnaires. Because subjects will be recruited within the University of Virginia Memory and Aging Care Clinic and provided clinical services through this clinic that intersect with their participation in this study, we will be collecting identifying information. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. We are specifically concerned about the potential for negative consequences subsequent to deductive disclosure due to the sensitive nature of the behavioral and diagnostic information being obtained in this study and the potential for these consequences to affect both the study subject and the PWD for whom they provide care.
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: We will make this final research data available by the time of publication of the main findings from the final dataset.
ipd access criteria: we will make the final research data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.