<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/NCT03786471</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 18-001796</org_study_id>
    <secondary_id>R01AG061078-01</secondary_id>
    <secondary_id>PCS-2017C1-6534</secondary_id>
    <nct_id>NCT03786471</nct_id>
  </id_info>
  <brief_title>D-CARE - The Dementia Care Study: A Pragmatic Clinical Trial of Health System-Based Versus Community-Based Dementia Care</brief_title>
  <acronym>D-CARE</acronym>
  <official_title>Comparative Effectiveness of Health System-based Versus Community-Based Dementia Care / A Pragmatic Clinical Trial of the Effectiveness and Cost-Effectiveness of Dementia Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Benjamin Rose Institute on Aging</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baylor Scott and White Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Texas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Geisinger Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RAND</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      D-CARE: The Dementia Care Study&#xD;
&#xD;
      This pragmatic randomized clinical trial of 2150 persons with dementia and their caregivers,&#xD;
      at four diverse clinical trial sites in the United States, will compare the effectiveness and&#xD;
      cost-effectiveness of 18 months of health systems-based dementia care provided by a Dementia&#xD;
      Care Specialist (nurse practitioner or physician assistant) who works within the heath system&#xD;
      versus community-based dementia care provided by a Care Consultant (social worker or nurse)&#xD;
      who works at a Community-Based Organization (CBO).&#xD;
&#xD;
      The trial will also compare the effectiveness and cost-effectiveness of both models versus&#xD;
      usual care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      D-CARE: The Dementia Care Study&#xD;
&#xD;
      Objective: To determine the comparative effectiveness and cost-effectiveness of two&#xD;
      evidence-based models of comprehensive dementia care, as well as the effectiveness and&#xD;
      cost-effectiveness of both models versus usual care.&#xD;
&#xD;
      Design: A pragmatic randomized 3-arm superiority trial. The unit of randomization is the&#xD;
      patient/caregiver dyad.&#xD;
&#xD;
      Duration: 6.5 years. This includes 34 months for recruitment of study participants, 18 months&#xD;
      of interventions/usual care, and simultaneously 18 months of follow-up for research purposes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 28, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</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>2150 dyads of persons with dementia and their respective primary caregiver&#xD;
1000 in each intervention arm, and 150 in the usual care arm</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Severity of Dementia-related Behavioral Symptoms</measure>
    <time_frame>18 months</time_frame>
    <description>The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Caregiver Distress</measure>
    <time_frame>18 months</time_frame>
    <description>The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms</measure>
    <time_frame>18 months</time_frame>
    <description>Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Depression in Caregivers</measure>
    <time_frame>18 months</time_frame>
    <description>The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores &gt;10 indicating moderate symptoms and scores &gt;20 indicating severe depressive symptoms. The outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Self-Efficacy: 4-item self-efficacy scale</measure>
    <time_frame>18 months</time_frame>
    <description>Caregivers' ability to manage dementia-related problems and ability to access help is measured with a 4-item self-efficacy scale [range, 1 to 5 (best)] measuring the caregiver's self-efficacy for caring for the patient with dementia and for accessing help, including community resources. The outcome will be a least squares marginal mean based on follow-up measurements at 6 and 18 months.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of Life of People with Dementia: QOL-AD</measure>
    <time_frame>18 months</time_frame>
    <description>Quality of life as measured by the Quality of Life in Alzheimer's Disease (QOL-AD). The QOL-AD is a 13-item instrument scored 4-52 (higher scores indicate better quality of life) that can be administered to persons with dementia and caregivers. It has demonstrated sensitivity to psychosocial intervention correlates with health-utility measures, is widely translated and used internationally and can be used by people with Mini-Mental State Exam (MMSE) scores as low as three. The outcome will be measured at 18 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost-Effectiveness Relative to Severity of Dementia-related Behavioral Symptoms</measure>
    <time_frame>18 months</time_frame>
    <description>The cost-effectiveness of the interventions compared to usual care is the ratio of incremental net costs to incremental effects of the NPI-Q-Severity. Thus, the ratio will be the net costs per unit change in NPI-Q-Severity. Costs will be taken from the perspective of Medicare. The net costs of the interventions are the costs of training for and doing the intervention less the cost offsets of reduced medical care and caregiving, if any, they bring about. The intervention costs, primarily labor, will be collected at the sites.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost-Effectiveness Relative to Caregiver Distress</measure>
    <time_frame>18 months</time_frame>
    <description>The cost-effectiveness of the interventions compared to usual care is the ratio of incremental net costs to incremental effects of the Modified Caregiver Strain Index (MCSI). Thus, the ratio will be the net costs per unit change in MCSI. Costs will be taken from the perspective of Medicare. The net costs of the interventions are the costs of training for and doing the intervention less the cost offsets of reduced medical care and caregiving, if any, they bring about. The intervention costs, primarily labor, will be collected at the sites.</description>
  </other_outcome>
  <other_outcome>
    <measure>Functional Status measured by FAQ</measure>
    <time_frame>18 months</time_frame>
    <description>Functional status measured using the Functional Activities Questionnaire (FAQ). FAQ ranges from 0 to 30 with higher scores indicating more functional dependence. The outcome will be measured at 18 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Functional Status measured by ADLs</measure>
    <time_frame>18 months</time_frame>
    <description>Functional status measured using Katz' Index of Independence in Activities of Daily Living (ADL) ranges from 0 to 6 with higher scores indicating more functional independence. The outcome will be measured at 18 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Goal Attainment</measure>
    <time_frame>18 months</time_frame>
    <description>Asks patients &amp; caregivers to select their most important goal and assesses their progress towards meeting it as a result of one of the study's intervention. Goal attainment, defined as whether a person's individual goals are achieved as a result of the study intervention, will be measured using a 5-point goal attainment scale (GAS). GAS describes the person's expected level of goal achievement over a specified timeframe, ranging from much worse than expected (scored as -2) to much better than expected (scored as +2). Scales are dynamically set according to a person's needs, while measurement of attainment is standardized. The outcome will be a least squares marginal mean based on follow-up measurements at 6 and 18 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Time Spent at Home</measure>
    <time_frame>18 months</time_frame>
    <description>Time spent at home is defined as [number of days since randomization - (number of inpatient days spent at an acute care hospital, inpatient rehabilitation facility, skill nursing facility, long-term care facility, or inpatient hospice unit)/Number of days since randomization].</description>
  </other_outcome>
  <other_outcome>
    <measure>Inpatient Days Spent at an Acute Care Hospital</measure>
    <time_frame>18 months</time_frame>
    <description>Inpatient Days Spent at an Acute Care Hospital is defined as the number of days an individual is admitted to an acute care hospital. This outcome will be attained using data from the Centers for Medicare and Medicaid Services (CMS).</description>
  </other_outcome>
  <other_outcome>
    <measure>Inpatient Days Spent at an Inpatient Rehabilitation Facility</measure>
    <time_frame>18 months</time_frame>
    <description>Inpatient Days Spent at an Inpatient Rehabilitation Facility is defined as the number of days an individual is admitted to an inpatient rehabilitation facility. This outcome will be attained using data from CMS.</description>
  </other_outcome>
  <other_outcome>
    <measure>Inpatient Days Spent at a Skilled Nursing Facility</measure>
    <time_frame>18 months</time_frame>
    <description>Inpatient Days Spent at a Skilled Nursing Facility is defined as the number of days an individual is admitted to a Skilled Nursing Facility. This outcome will be attained using data from CMS.</description>
  </other_outcome>
  <other_outcome>
    <measure>Inpatient Days Spent at a Long-term Care Facility</measure>
    <time_frame>18 months</time_frame>
    <description>Inpatient Days Spent at a Long-term Care Facility is defined as the number of days an individual is admitted to a Long-term Care Facility. This outcome will be attained using data from CMS.</description>
  </other_outcome>
  <other_outcome>
    <measure>Days Spent Receiving Hospice Benefit</measure>
    <time_frame>18 months</time_frame>
    <description>Days Spent Receiving Hospice Benefit is defined as the number of days an individual is receiving hospice care regardless of location. This outcome will be attained using data from CMS.</description>
  </other_outcome>
  <other_outcome>
    <measure>Caregiver Assessment of Dementia Care</measure>
    <time_frame>18 months</time_frame>
    <description>Caregiver's satisfaction with the dementia care program is measured using a 11-item questionnaire, modified from the University of California Los Angeles' Alzheimer's and Dementia Care program, with ranges from 11 to 55 (higher scores indicate greater caregiver satisfaction with the dementia care program). The questionnaire will be administered at 3, 12 and 18 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Caregiver Rating of Dementia Care Quality</measure>
    <time_frame>12 months</time_frame>
    <description>Caregiver Rating of Dementia Care Quality is a composite instrument of 10 items (with yes or no responses) from the Assessing Care of Vulnerable Elders (ACOVE), Physician Consortium for Performance Improvement (PCPI) and the American Academy of Neurology (AAN) quality measures. The outcome is a count of the number of yes responses (range 0-10, higher counts indicate greater caregiver rating of satisfaction of dementia care quality).</description>
  </other_outcome>
  <other_outcome>
    <measure>Physician Assessment of Dementia Care at 18 Months</measure>
    <time_frame>18 months</time_frame>
    <description>The level of physician satisfaction with dementia care programs as measured by the Physician Assessment of Dementia Care (PADC). The PADC is an 5-item questionnaire modified from UCLA's Alzheimer's and Dementia Care program. Each item will be examined individually (with the range of each item differing). The questionnaire will be administered at 18 months, when the provider's first enrolled patient completes the study. All providers with at least one enrolled patient in the study will be surveyed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Persons with Dementia that Die Over the Course of the Study</measure>
    <time_frame>18 months</time_frame>
    <description>Mortality of persons with dementia as measured by interviews with caregivers at 3, 6 and 12 months, and data from the Center for Medicare and Medicaid Services at 18 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cognition of Persons with Dementia</measure>
    <time_frame>18 months</time_frame>
    <description>Cognition as measured by the Montreal Cognitive Assessment (MoCA). MoCA is a validated widely used test of cognition that captures mild cognitive impairment as well as dementia. This will be collected at baseline by telephone and at the end of the study to document disease progression.&#xD;
To reduce respondent burden and missing data, we will use a shortened 3-item form (a 0-12 point scale for evaluating memory, verbal fluency, and orientation only) for reporting study participant baseline characteristics and measuring the decline in cognition. Participants who score 8 or higher on the shortened version will receive the full 22-item telephone MOCA to determine whether they have capacity to provide informed consent.</description>
  </other_outcome>
  <other_outcome>
    <measure>Spouse Caregiver Inpatient Days Spent at an Acute Care Hospital</measure>
    <time_frame>18 months</time_frame>
    <description>Inpatient Days Spent at an Acute Care Hospital is defined as the number of days an individual is admitted to an acute care hospital. This outcome will be attained using data from CMS.</description>
  </other_outcome>
  <other_outcome>
    <measure>Spouse Caregiver Inpatient Days Spent at an Inpatient Rehabilitation Facility</measure>
    <time_frame>18 months</time_frame>
    <description>Inpatient Days Spent at an Inpatient Rehabilitation Facility is defined as the number of days an individual is admitted to an inpatient rehabilitation facility. This outcome will be attained using data from CMS.</description>
  </other_outcome>
  <other_outcome>
    <measure>Spouse Caregiver Inpatient Days Spent at a Skilled Nursing Facility</measure>
    <time_frame>18 months</time_frame>
    <description>Inpatient Days Spent at a Skilled Nursing Facility is defined as the number of days an individual is admitted to a Skilled Nursing Facility. This outcome will be attained using data from CMS.</description>
  </other_outcome>
  <other_outcome>
    <measure>Spouse Caregiver Inpatient Days Spent at a Long-term Care Facility</measure>
    <time_frame>18 months</time_frame>
    <description>Inpatient Days Spent at a Long-term Care Facility is defined as the number of days an individual is admitted to a Long-term Care Facility. This outcome will be attained using data from CMS.</description>
  </other_outcome>
  <other_outcome>
    <measure>Spouse Caregiver Days Spent Receiving Hospice Benefit</measure>
    <time_frame>18 months</time_frame>
    <description>Days Spent Receiving Hospice Benefit is defined as the number of days an individual is receiving hospice care regardless of location. This outcome will be attained using data from CMS.</description>
  </other_outcome>
  <other_outcome>
    <measure>Spouse Caregiver Utilization of Preventive Services</measure>
    <time_frame>18 months</time_frame>
    <description>Use of sex and age appropriate Medicare-covered preventive services. This outcome will be attained using data from CMS.</description>
  </other_outcome>
  <other_outcome>
    <measure>Spouse Caregiver Utilization of Annual Wellness Visit</measure>
    <time_frame>18 months</time_frame>
    <description>Use of Medicare-covered Annual Wellness Visit. This outcome will be attained using data from CMS.</description>
  </other_outcome>
  <other_outcome>
    <measure>Dementia Burden (Caregiver)</measure>
    <time_frame>18 months</time_frame>
    <description>Dementia Burden Scale-Caregiver (DBS-CG) is a composite of the NPI-Q Distress, MCSI, and PHQ-8 scales with items transformed linearly to be on a 0-100 possible range and then averaged with higher scores indicating higher caregiver burden. The minimal clinically important difference (MCID) for the DBS-CG is 5 points. The outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical Benefit</measure>
    <time_frame>18 months</time_frame>
    <description>Clinical benefit is a binary measure of patient symptoms using the NPI-Q severity scale (the only patient outcome anticipated to benefit from the program) and caregiver symptoms using the DBS-CG scale. Benefit on the NPI-Q severity scale is defined as having a 1-year score of &lt; 6 (the lowest tertile of symptoms) or improving by at least 3 points, the MCID. DBS-CG benefit is defined as having a 1-year score of &lt; 18.8 (the lowest tertile of symptoms) or improving by at least 5 points, the MCID. Defining benefit in this manner captures both preventive (those who have few symptoms at baseline and do not deteriorate) and therapeutic (those who improve) benefit from the program. The outcome will be an overall odds ratio based on follow-up measurements at 3, 6, 12 and 18 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Positive Aspects of Family Caregiving</measure>
    <time_frame>6 months</time_frame>
    <description>The positive aspects of family caregiving as measured by the Positive Aspects of Family Caregiving Questionnaire, which is an 11-item tool to assess favorable aspects of caregiving experiences, and is scored from 0 to 44 (most positive) with higher scores indicating a more positive mental and affective state related to the caregiver's experience. The outcome will be measured at 6 months.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">2150</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Health Systems-Based Dementia Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Community-Based Dementia Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (Social Workers or Nurses). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Health System-based Dementia Care</intervention_name>
    <description>Active comparator</description>
    <arm_group_label>Health Systems-Based Dementia Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Community-based Dementia Care</intervention_name>
    <description>Active comparator</description>
    <arm_group_label>Community-Based Dementia Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Control</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The person with dementia has a diagnosis of dementia established by a physician or&#xD;
             other primary care provider&#xD;
&#xD;
          -  The person with dementia has a primary care provider who is willing to partner with&#xD;
             the study&#xD;
&#xD;
          -  The person with dementia has a caregiver who speaks English or Spanish, and has a&#xD;
             phone&#xD;
&#xD;
          -  Persons living with dementia in assisted living facilities will be eligible if they do&#xD;
             not meet any exclusion criteria (however, no more than 25% of participants can be&#xD;
             living in assisted living facilities at the time of enrollment. This will be monitored&#xD;
             when the first 25% of the sample has been enrolled.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The person with dementia resides in a nursing home at the time of recruitment&#xD;
&#xD;
          -  The person with dementia is enrolled in hospice at the time of screen&#xD;
&#xD;
          -  The person with dementia plans to move out of the area within the coming year&#xD;
&#xD;
          -  The caregiver of the person with dementia is unwilling or anticipates being incapable&#xD;
             of providing self-reported outcome measures for 18 months&#xD;
&#xD;
          -  Baseline measures refused or not completed&#xD;
&#xD;
          -  The caregiver is paid, and is not a relative or close friend of the person with&#xD;
             dementia&#xD;
&#xD;
          -  At telephone or in-person screener, the caregiver has cognitive impairment&#xD;
&#xD;
          -  The person with dementia or caregiver is participating in another dementia&#xD;
             intervention study&#xD;
&#xD;
          -  Patients and caregivers who are members of a sites' Local Patient &amp; Stakeholder&#xD;
             Committee&#xD;
&#xD;
          -  There is already a member of the same household participating in the study.&#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>David Reuben, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas Gill, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Bass, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Benjamin Rose Institute on Aging</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lee Jennings, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oklohoma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maya Lichtenstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Geisinger Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Peduzzi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alan Stevens, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor Scott and White Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elena Volpi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffrey Williamson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christopher Callahan</last_name>
    <role>Study Chair</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katie Maslow</last_name>
    <role>Study Chair</role>
    <affiliation>Gerontological Society of America</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jenny Summapund</last_name>
    <role>Study Director</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Health</name>
      <address>
        <city>Wilkes-Barre</city>
        <state>Pennsylvania</state>
        <zip>18765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>March 23, 2023</last_update_submitted>
  <last_update_submitted_qc>March 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>David B. Reuben, MD</investigator_full_name>
    <investigator_title>Director, Multicampus Program in Geriatric Medicine &amp; Gerontology; Chief, Division of Geriatrics</investigator_title>
  </responsible_party>
  <keyword>dementia</keyword>
  <keyword>pragmatic clinical trial</keyword>
  <keyword>effectiveness</keyword>
  <keyword>cost-effectiveness</keyword>
  <keyword>Alzheimer's disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03786471
org study id: IRB 18-001796
secondary id: R01AG061078-01
secondary id: PCS-2017C1-6534
nct id: NCT03786471
lead sponsor: 
collaborator: 
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has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
D-CARE: The Dementia Care Study

      This pragmatic randomized clinical trial of 2150 persons with dementia and their caregivers,
      at four diverse clinical trial sites in the United States, will compare the effectiveness and
      cost-effectiveness of 18 months of health systems-based dementia care provided by a Dementia
      Care Specialist (nurse practitioner or physician assistant) who works within the heath system
      versus community-based dementia care provided by a Care Consultant (social worker or nurse)
      who works at a Community-Based Organization (CBO).

      The trial will also compare the effectiveness and cost-effectiveness of both models versus
      usual care.
D-CARE: The Dementia Care Study

      Objective: To determine the comparative effectiveness and cost-effectiveness of two
      evidence-based models of comprehensive dementia care, as well as the effectiveness and
      cost-effectiveness of both models versus usual care.

      Design: A pragmatic randomized 3-arm superiority trial. The unit of randomization is the
      patient/caregiver dyad.

      Duration: 6.5 years. This includes 34 months for recruitment of study participants, 18 months
      of interventions/usual care, and simultaneously 18 months of follow-up for research purposes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2150 dyads of persons with dementia and their respective primary caregiver
1000 in each intervention arm, and 150 in the usual care arm
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: Severity of Dementia-related Behavioral Symptoms
time frame: 18 months
description: The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.
measure: Caregiver Distress
time frame: 18 months
description: The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.
measure: Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms
time frame: 18 months
description: Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.
measure: Severity of Depression in Caregivers
time frame: 18 months
description: The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores >10 indicating moderate symptoms and scores >20 indicating severe depressive symptoms. The outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.
measure: Caregiver Self-Efficacy: 4-item self-efficacy scale
time frame: 18 months
description: Caregivers' ability to manage dementia-related problems and ability to access help is measured with a 4-item self-efficacy scale [range, 1 to 5 (best)] measuring the caregiver's self-efficacy for caring for the patient with dementia and for accessing help, including community resources. The outcome will be a least squares marginal mean based on follow-up measurements at 6 and 18 months.
measure: Quality of Life of People with Dementia: QOL-AD
time frame: 18 months
description: Quality of life as measured by the Quality of Life in Alzheimer's Disease (QOL-AD). The QOL-AD is a 13-item instrument scored 4-52 (higher scores indicate better quality of life) that can be administered to persons with dementia and caregivers. It has demonstrated sensitivity to psychosocial intervention correlates with health-utility measures, is widely translated and used internationally and can be used by people with Mini-Mental State Exam (MMSE) scores as low as three. The outcome will be measured at 18 months.
measure: Cost-Effectiveness Relative to Severity of Dementia-related Behavioral Symptoms
time frame: 18 months
description: The cost-effectiveness of the interventions compared to usual care is the ratio of incremental net costs to incremental effects of the NPI-Q-Severity. Thus, the ratio will be the net costs per unit change in NPI-Q-Severity. Costs will be taken from the perspective of Medicare. The net costs of the interventions are the costs of training for and doing the intervention less the cost offsets of reduced medical care and caregiving, if any, they bring about. The intervention costs, primarily labor, will be collected at the sites.
measure: Cost-Effectiveness Relative to Caregiver Distress
time frame: 18 months
description: The cost-effectiveness of the interventions compared to usual care is the ratio of incremental net costs to incremental effects of the Modified Caregiver Strain Index (MCSI). Thus, the ratio will be the net costs per unit change in MCSI. Costs will be taken from the perspective of Medicare. The net costs of the interventions are the costs of training for and doing the intervention less the cost offsets of reduced medical care and caregiving, if any, they bring about. The intervention costs, primarily labor, will be collected at the sites.
measure: Functional Status measured by FAQ
time frame: 18 months
description: Functional status measured using the Functional Activities Questionnaire (FAQ). FAQ ranges from 0 to 30 with higher scores indicating more functional dependence. The outcome will be measured at 18 months.
measure: Functional Status measured by ADLs
time frame: 18 months
description: Functional status measured using Katz' Index of Independence in Activities of Daily Living (ADL) ranges from 0 to 6 with higher scores indicating more functional independence. The outcome will be measured at 18 months.
measure: Goal Attainment
time frame: 18 months
description: Asks patients & caregivers to select their most important goal and assesses their progress towards meeting it as a result of one of the study's intervention. Goal attainment, defined as whether a person's individual goals are achieved as a result of the study intervention, will be measured using a 5-point goal attainment scale (GAS). GAS describes the person's expected level of goal achievement over a specified timeframe, ranging from much worse than expected (scored as -2) to much better than expected (scored as +2). Scales are dynamically set according to a person's needs, while measurement of attainment is standardized. The outcome will be a least squares marginal mean based on follow-up measurements at 6 and 18 months.
measure: Time Spent at Home
time frame: 18 months
description: Time spent at home is defined as [number of days since randomization - (number of inpatient days spent at an acute care hospital, inpatient rehabilitation facility, skill nursing facility, long-term care facility, or inpatient hospice unit)/Number of days since randomization].
measure: Inpatient Days Spent at an Acute Care Hospital
time frame: 18 months
description: Inpatient Days Spent at an Acute Care Hospital is defined as the number of days an individual is admitted to an acute care hospital. This outcome will be attained using data from the Centers for Medicare and Medicaid Services (CMS).
measure: Inpatient Days Spent at an Inpatient Rehabilitation Facility
time frame: 18 months
description: Inpatient Days Spent at an Inpatient Rehabilitation Facility is defined as the number of days an individual is admitted to an inpatient rehabilitation facility. This outcome will be attained using data from CMS.
measure: Inpatient Days Spent at a Skilled Nursing Facility
time frame: 18 months
description: Inpatient Days Spent at a Skilled Nursing Facility is defined as the number of days an individual is admitted to a Skilled Nursing Facility. This outcome will be attained using data from CMS.
measure: Inpatient Days Spent at a Long-term Care Facility
time frame: 18 months
description: Inpatient Days Spent at a Long-term Care Facility is defined as the number of days an individual is admitted to a Long-term Care Facility. This outcome will be attained using data from CMS.
measure: Days Spent Receiving Hospice Benefit
time frame: 18 months
description: Days Spent Receiving Hospice Benefit is defined as the number of days an individual is receiving hospice care regardless of location. This outcome will be attained using data from CMS.
measure: Caregiver Assessment of Dementia Care
time frame: 18 months
description: Caregiver's satisfaction with the dementia care program is measured using a 11-item questionnaire, modified from the University of California Los Angeles' Alzheimer's and Dementia Care program, with ranges from 11 to 55 (higher scores indicate greater caregiver satisfaction with the dementia care program). The questionnaire will be administered at 3, 12 and 18 months.
measure: Caregiver Rating of Dementia Care Quality
time frame: 12 months
description: Caregiver Rating of Dementia Care Quality is a composite instrument of 10 items (with yes or no responses) from the Assessing Care of Vulnerable Elders (ACOVE), Physician Consortium for Performance Improvement (PCPI) and the American Academy of Neurology (AAN) quality measures. The outcome is a count of the number of yes responses (range 0-10, higher counts indicate greater caregiver rating of satisfaction of dementia care quality).
measure: Physician Assessment of Dementia Care at 18 Months
time frame: 18 months
description: The level of physician satisfaction with dementia care programs as measured by the Physician Assessment of Dementia Care (PADC). The PADC is an 5-item questionnaire modified from UCLA's Alzheimer's and Dementia Care program. Each item will be examined individually (with the range of each item differing). The questionnaire will be administered at 18 months, when the provider's first enrolled patient completes the study. All providers with at least one enrolled patient in the study will be surveyed.
measure: Number of Persons with Dementia that Die Over the Course of the Study
time frame: 18 months
description: Mortality of persons with dementia as measured by interviews with caregivers at 3, 6 and 12 months, and data from the Center for Medicare and Medicaid Services at 18 months.
measure: Cognition of Persons with Dementia
time frame: 18 months
description: Cognition as measured by the Montreal Cognitive Assessment (MoCA). MoCA is a validated widely used test of cognition that captures mild cognitive impairment as well as dementia. This will be collected at baseline by telephone and at the end of the study to document disease progression.
To reduce respondent burden and missing data, we will use a shortened 3-item form (a 0-12 point scale for evaluating memory, verbal fluency, and orientation only) for reporting study participant baseline characteristics and measuring the decline in cognition. Participants who score 8 or higher on the shortened version will receive the full 22-item telephone MOCA to determine whether they have capacity to provide informed consent.
measure: Spouse Caregiver Inpatient Days Spent at an Acute Care Hospital
time frame: 18 months
description: Inpatient Days Spent at an Acute Care Hospital is defined as the number of days an individual is admitted to an acute care hospital. This outcome will be attained using data from CMS.
measure: Spouse Caregiver Inpatient Days Spent at an Inpatient Rehabilitation Facility
time frame: 18 months
description: Inpatient Days Spent at an Inpatient Rehabilitation Facility is defined as the number of days an individual is admitted to an inpatient rehabilitation facility. This outcome will be attained using data from CMS.
measure: Spouse Caregiver Inpatient Days Spent at a Skilled Nursing Facility
time frame: 18 months
description: Inpatient Days Spent at a Skilled Nursing Facility is defined as the number of days an individual is admitted to a Skilled Nursing Facility. This outcome will be attained using data from CMS.
measure: Spouse Caregiver Inpatient Days Spent at a Long-term Care Facility
time frame: 18 months
description: Inpatient Days Spent at a Long-term Care Facility is defined as the number of days an individual is admitted to a Long-term Care Facility. This outcome will be attained using data from CMS.
measure: Spouse Caregiver Days Spent Receiving Hospice Benefit
time frame: 18 months
description: Days Spent Receiving Hospice Benefit is defined as the number of days an individual is receiving hospice care regardless of location. This outcome will be attained using data from CMS.
measure: Spouse Caregiver Utilization of Preventive Services
time frame: 18 months
description: Use of sex and age appropriate Medicare-covered preventive services. This outcome will be attained using data from CMS.
measure: Spouse Caregiver Utilization of Annual Wellness Visit
time frame: 18 months
description: Use of Medicare-covered Annual Wellness Visit. This outcome will be attained using data from CMS.
measure: Dementia Burden (Caregiver)
time frame: 18 months
description: Dementia Burden Scale-Caregiver (DBS-CG) is a composite of the NPI-Q Distress, MCSI, and PHQ-8 scales with items transformed linearly to be on a 0-100 possible range and then averaged with higher scores indicating higher caregiver burden. The minimal clinically important difference (MCID) for the DBS-CG is 5 points. The outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.
measure: Clinical Benefit
time frame: 18 months
description: Clinical benefit is a binary measure of patient symptoms using the NPI-Q severity scale (the only patient outcome anticipated to benefit from the program) and caregiver symptoms using the DBS-CG scale. Benefit on the NPI-Q severity scale is defined as having a 1-year score of < 6 (the lowest tertile of symptoms) or improving by at least 3 points, the MCID. DBS-CG benefit is defined as having a 1-year score of < 18.8 (the lowest tertile of symptoms) or improving by at least 5 points, the MCID. Defining benefit in this manner captures both preventive (those who have few symptoms at baseline and do not deteriorate) and therapeutic (those who improve) benefit from the program. The outcome will be an overall odds ratio based on follow-up measurements at 3, 6, 12 and 18 months.
measure: Positive Aspects of Family Caregiving
time frame: 6 months
description: The positive aspects of family caregiving as measured by the Positive Aspects of Family Caregiving Questionnaire, which is an 11-item tool to assess favorable aspects of caregiving experiences, and is scored from 0 to 44 (most positive) with higher scores indicating a more positive mental and affective state related to the caregiver's experience. The outcome will be measured at 6 months.
arm group label: Health Systems-Based Dementia Care
arm group type: Active Comparator
description: Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program.
arm group label: Community-Based Dementia Care
arm group type: Active Comparator
description: Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (Social Workers or Nurses). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program.
arm group label: Usual Care
arm group type: Other
description: Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services.
intervention type: Other
intervention name: Health System-based Dementia Care
description: Active comparator
arm group label: Health Systems-Based Dementia Care
intervention type: Other
intervention name: Community-based Dementia Care
description: Active comparator
arm group label: Community-Based Dementia Care
intervention type: Other
intervention name: Usual Care
description: Control
arm group label: Usual Care
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: David Reuben, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Thomas Gill, MD
role: Principal Investigator
affiliation: Yale University
last name: David Bass, PhD
role: Principal Investigator
affiliation: Benjamin Rose Institute on Aging
last name: Lee Jennings, MD
role: Principal Investigator
affiliation: University of Oklohoma
last name: Maya Lichtenstein, MD
role: Principal Investigator
affiliation: Geisinger Clinic
last name: Peter Peduzzi, MD
role: Principal Investigator
affiliation: Yale University
last name: Alan Stevens, PhD
role: Principal Investigator
affiliation: Baylor Scott and White Health
last name: Elena Volpi, MD
role: Principal Investigator
affiliation: University of Texas
last name: Jeffrey Williamson, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
last name: Christopher Callahan
role: Study Chair
affiliation: Indiana University
last name: Katie Maslow
role: Study Chair
affiliation: Gerontological Society of America
last name: Jenny Summapund
role: Study Director
affiliation: University of California, Los Angeles
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: David B. Reuben, MD
investigator title: Director, Multicampus Program in Geriatric Medicine & Gerontology; Chief, Division of Geriatrics
mesh term: Dementia
sharing ipd: No