<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/NCT03255967</url>
  </required_header>
  <id_info>
    <org_study_id>17-00810</org_study_id>
    <nct_id>NCT03255967</nct_id>
  </id_info>
  <brief_title>Dementia Symptom Management at Home Program</brief_title>
  <official_title>A Multisite Cluster RCT of the Dementia Symptom Management at Home Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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>
      Alzheimer's Disease and Related Disorders (dementia) poses a significant challenge to our&#xD;
      public health. While many persons with dementia are cared for by friends and family in the&#xD;
      community with the assistance of home healthcare, most home healthcare clinicians and&#xD;
      agencies are ill prepared to care for this population and therefore have difficulty assisting&#xD;
      patients and caregivers in maintaining quality of life leading to adverse patient outcomes,&#xD;
      increased caregiver stress and burnout, and healthcare utilization. This study will therefore&#xD;
      utilize a cluster randomized controlled design at 3 study sites to examine the ability of a&#xD;
      multi-component evidence-based practice primary palliative care quality improvement program&#xD;
      for home healthcare registered nurses, occupational therapists and physical therapists to&#xD;
      improve the quality of life and reduce healthcare utilization for persons with dementia and&#xD;
      their informal caregiver.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2018</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 31, 2022</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Quality of Life-Alzheimer's Disease Score</measure>
    <time_frame>Baseline, Day 60</time_frame>
    <description>13-item measurement of Alzheimer's disease patients' health-related quality of life (HRQOL) by proxy (caregiver) assessment. Each item is rated on a 4-point Likert scale ranging from 1 (poor) to 4 (excellent). The total score is the sum of responses; higher scores indicate greater HRQOL. An increase in scores indicates HRQOL increased during the observational period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Caregiver-Targeted Quality of Life Measure Score</measure>
    <time_frame>Baseline, Day 60</time_frame>
    <description>The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across 10 scales: assistance with ADLs, assistance with IADLs, personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life improved over the observational period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of ER Visits by Patients with Dementia (PWD) during Study Period</measure>
    <time_frame>Up to Day 60</time_frame>
    <description>Measured through interviews with the informal caregiver using the Resource Utilization Inventory.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of PWD Inpatient Admissions during Study Period</measure>
    <time_frame>Up to Day 60</time_frame>
    <description>Measured through interviews with the informal caregiver using the Resource Utilization Inventory.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Assessment In Advanced Dementia (PAINAD) Score</measure>
    <time_frame>Baseline, Day 60</time_frame>
    <description>5-item assessment of pain in individuals with advanced dementia. Items are ranked on a 3-point Likert scale from 0 to 2. The total score is the sum of responses and ranges from 0 (no pain) to 10 (severe pain). An increase in scores indicates pain increased during the observational period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score</measure>
    <time_frame>Baseline, Day 60</time_frame>
    <description>13-item tool that measures caregiver perceptions of Behavioral and Psychological Symptoms of Dementia (BPSD). For each item, The severity of the reported symptoms is assessed on a 3-point scale. The total severity score ranges from 0 to 36 with higher scores representing worse severity. An increase in score indicates severity of BPSD increased during the observational period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of PWD who Use Antipsychotics during Study Period</measure>
    <time_frame>Up to Day 60</time_frame>
    <description>Measured via patient medication record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of PWD who Use Analgesics during Study Period</measure>
    <time_frame>Up to Day 60</time_frame>
    <description>Measured via patient medication record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of PWD Outpatient Visits during Study Period</measure>
    <time_frame>Up to Day 60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of PWD Primary Care Provider Contacts during Study Period</measure>
    <time_frame>Up to Day 60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Zarit Burden Inventory Score among Caregivers</measure>
    <time_frame>Baseline, Day 60</time_frame>
    <description>22-item self-assessment of burden experienced by caregivers. Items are ranked on a Likert scale from 0 (never) to 4 (nearly always). The total score is the sum of responses and ranges from 0 to 88, where: 0 - 21 = little or no burden; 21 - 40 = mild to moderate burden; 41 - 60 = moderate to severe burden; and 61 - 88 = severe burden. An increase in scores indicates burden increased during the observational period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Public Health Questionnaire-9 (PHQ-9) Score among Caregivers</measure>
    <time_frame>Baseline, Day 60</time_frame>
    <description>9-item measurement of depression in which caregivers indicate how often they have been bothered by specific problems over the previous 2 weeks. Items are ranked on 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater severity of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Short-Form-12 (SF-12) Score among Caregivers</measure>
    <time_frame>Baseline, Day 60</time_frame>
    <description>12-item tool that measures functional health and well-being. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Physical and Mental Health Composite Scores (PCS &amp; MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">217</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>QI program care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>provide usual carereceive usual care from a care team who has not received the performance improvement program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DSM-H</intervention_name>
    <description>Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC</description>
    <arm_group_label>QI program care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Subjects receive care through usual home healthcare assignment process.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PWD over the age of 65&#xD;
&#xD;
          -  Admitted to one of the three HHC agencies&#xD;
&#xD;
          -  The patient and family caregiver speak English and/or Spanish.&#xD;
&#xD;
          -  The informal caregiver is ≥18 years of age and spends at least 8 hours per week with&#xD;
             the patient.&#xD;
&#xD;
          -  Patients who score ≥6 on the Quick Dementia Rating Scale (at least mild impairment).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a separate Axis 1 diagnosis other than forms of dementia, depression or&#xD;
             anxiety.&#xD;
&#xD;
          -  PWD residing in assisted living facilities or board and care homes&#xD;
&#xD;
          -  PWD solely receiving infusion or home health aide services.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abraham Brody, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</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>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>December 5, 2022</last_update_submitted>
  <last_update_submitted_qc>December 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>April 11, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03255967
org study id: 17-00810
nct id: NCT03255967
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Alzheimer's Disease and Related Disorders (dementia) poses a significant challenge to our
      public health. While many persons with dementia are cared for by friends and family in the
      community with the assistance of home healthcare, most home healthcare clinicians and
      agencies are ill prepared to care for this population and therefore have difficulty assisting
      patients and caregivers in maintaining quality of life leading to adverse patient outcomes,
      increased caregiver stress and burnout, and healthcare utilization. This study will therefore
      utilize a cluster randomized controlled design at 3 study sites to examine the ability of a
      multi-component evidence-based practice primary palliative care quality improvement program
      for home healthcare registered nurses, occupational therapists and physical therapists to
      improve the quality of life and reduce healthcare utilization for persons with dementia and
      their informal caregiver.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in Quality of Life-Alzheimer's Disease Score
time frame: Baseline, Day 60
description: 13-item measurement of Alzheimer's disease patients' health-related quality of life (HRQOL) by proxy (caregiver) assessment. Each item is rated on a 4-point Likert scale ranging from 1 (poor) to 4 (excellent). The total score is the sum of responses; higher scores indicate greater HRQOL. An increase in scores indicates HRQOL increased during the observational period.
measure: Change in Caregiver-Targeted Quality of Life Measure Score
time frame: Baseline, Day 60
description: The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across 10 scales: assistance with ADLs, assistance with IADLs, personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life improved over the observational period.
measure: Number of ER Visits by Patients with Dementia (PWD) during Study Period
time frame: Up to Day 60
description: Measured through interviews with the informal caregiver using the Resource Utilization Inventory.
measure: Number of PWD Inpatient Admissions during Study Period
time frame: Up to Day 60
description: Measured through interviews with the informal caregiver using the Resource Utilization Inventory.
measure: Change in Pain Assessment In Advanced Dementia (PAINAD) Score
time frame: Baseline, Day 60
description: 5-item assessment of pain in individuals with advanced dementia. Items are ranked on a 3-point Likert scale from 0 to 2. The total score is the sum of responses and ranges from 0 (no pain) to 10 (severe pain). An increase in scores indicates pain increased during the observational period.
measure: Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score
time frame: Baseline, Day 60
description: 13-item tool that measures caregiver perceptions of Behavioral and Psychological Symptoms of Dementia (BPSD). For each item, The severity of the reported symptoms is assessed on a 3-point scale. The total severity score ranges from 0 to 36 with higher scores representing worse severity. An increase in score indicates severity of BPSD increased during the observational period.
measure: Number of PWD who Use Antipsychotics during Study Period
time frame: Up to Day 60
description: Measured via patient medication record.
measure: Number of PWD who Use Analgesics during Study Period
time frame: Up to Day 60
description: Measured via patient medication record.
measure: Number of PWD Outpatient Visits during Study Period
time frame: Up to Day 60
measure: Number of PWD Primary Care Provider Contacts during Study Period
time frame: Up to Day 60
measure: Change in Zarit Burden Inventory Score among Caregivers
time frame: Baseline, Day 60
description: 22-item self-assessment of burden experienced by caregivers. Items are ranked on a Likert scale from 0 (never) to 4 (nearly always). The total score is the sum of responses and ranges from 0 to 88, where: 0 - 21 = little or no burden; 21 - 40 = mild to moderate burden; 41 - 60 = moderate to severe burden; and 61 - 88 = severe burden. An increase in scores indicates burden increased during the observational period.
measure: Change in Public Health Questionnaire-9 (PHQ-9) Score among Caregivers
time frame: Baseline, Day 60
description: 9-item measurement of depression in which caregivers indicate how often they have been bothered by specific problems over the previous 2 weeks. Items are ranked on 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater severity of depression.
measure: Change in Short-Form-12 (SF-12) Score among Caregivers
time frame: Baseline, Day 60
description: 12-item tool that measures functional health and well-being. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
arm group label: QI program care
arm group type: Experimental
description: DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program
arm group label: Control
arm group type: Active Comparator
description: provide usual carereceive usual care from a care team who has not received the performance improvement program
intervention type: Behavioral
intervention name: DSM-H
description: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
arm group label: QI program care
intervention type: Behavioral
intervention name: Standard of Care
description: Subjects receive care through usual home healthcare assignment process.
arm group label: Control
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Abraham Brody, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dementia
submitted: April 11, 2023