<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/NCT03821844</url>
  </required_header>
  <id_info>
    <org_study_id>R33AG057451_part1</org_study_id>
    <secondary_id>R33AG057451</secondary_id>
    <nct_id>NCT03821844</nct_id>
  </id_info>
  <brief_title>Music &amp; MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease_part1</brief_title>
  <acronym>METRIcAL</acronym>
  <official_title>Music &amp; MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease_part1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Westat</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Brown University</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>
      The purpose of this trial is to test the effects of a personalized music intervention (Music&#xD;
      and Memory, Inc.) on agitated and aggressive behaviors for nursing home residents with&#xD;
      dementia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to conduct a parallel, pragmatic, cluster randomized control&#xD;
      trial of personalized music (Music and Memory) for nursing home residents with moderate to&#xD;
      severe dementia living in 54 nursing homes (27 treatment, 27 control) from 4 nursing home&#xD;
      corporations. Music and Memory is a personalized music program that uses portable music&#xD;
      players to deliver individualized music to people with dementia at times when agitated&#xD;
      behaviors are likely.&#xD;
&#xD;
      **This funding mechanism sponsored two parallel trials with different implementation&#xD;
      strategies. In this trial, nursing home staff identify the music a resident with dementia may&#xD;
      have preferred when s/he was young by asking family members and testing individual songs with&#xD;
      the resident. Details of the second parallel trial conducted under this funding mechanism are&#xD;
      registered under &quot;R33AG057451_part2.&quot;**&#xD;
&#xD;
      The aims of this study are: 1. To use a train-the-trainer model to implement the intervention&#xD;
      with ongoing monitoring of the program's adoption and acceptance by nursing home residents&#xD;
      with dementia; 2. To estimate the impact of Music and Memory on agitated and aggressive&#xD;
      behaviors; and 3. To examine factors associated with variation in providers' adherence to the&#xD;
      implementation of Music and Memory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">August 1, 2021</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>The investigator's primary outcome (staff report of resident agitated and aggressive behaviors) will be evaluated using a parallel design. Some secondary outcomes will be tested with a stepped wedge design.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The principal investigator is blinded to random assignment of nursing homes to treatment or control conditions</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of Agitated and Aggressive Behaviors (Staff Report)</measure>
    <time_frame>4-months</time_frame>
    <description>The tool used to interview staff about resident behaviors is the Cohen-Mansfield Agitation Inventory. Research staff interview a nursing staff member who knows the resident well to ask how frequently 29 agitated and/or aggressive behaviors occurred in the past week. There are seven response choices for each item, anchored from never (1) to several times per hour (7). Total scores on the Cohen-Mansfield Agitation Inventory range from 29 to 203, with higher scores representing more frequent agitated and/or aggressive behaviors. Adjusted mean overall scores will be compared for treatment and control populations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation)</measure>
    <time_frame>4-months</time_frame>
    <description>The tool used to directly observe resident behaviors is the Agitation Behavior Mapping Instrument. Research staff observe residents for short intervals (3 minutes per observation) and record the number of times 14 specific verbally and physically agitated behaviors occurred (up to 10 times per observation). Ordinal outcomes quantify the number of physical and verbal agitated behaviors that occurred during the ABMI observations. The levels of these outcomes are None (0), Some (1 - 3) and Many (4 or more) observed behaviors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Agitated and Aggressive Behaviors (Administrative Data)</measure>
    <time_frame>4-months</time_frame>
    <description>The Aggressive Behavior Scale is a 4-item measure describing the frequency of physical behavioral symptoms directed toward others; verbal behavioral symptoms directed toward others; other behavioral symptoms not directed toward others; and behaviors related to resisting necessary care. For each item, frequency in the past week is report as: behavior not exhibited (0); behavior occurred 1-3 days (1); behavior occurred 4-6 days (2); or behavior occurred daily (3). The Aggressive Behavior Scale ranges from 0 to 12, with higher scores indicating more frequent agitated and/or aggressive behaviors. Mean total scores will be compared for treatment and control populations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antipsychotic Use</measure>
    <time_frame>4-months</time_frame>
    <description>Any antipsychotic use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antianxietal Use</measure>
    <time_frame>4-months</time_frame>
    <description>Any antianxietal use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Measure type of mean is chosen based on adjusted percentage with standard errors from a multilevel, difference in difference regression models</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antidepressant Use</measure>
    <time_frame>4-months</time_frame>
    <description>Any antidepressant use in the past week and days of use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypnotic Use</measure>
    <time_frame>4-months</time_frame>
    <description>Any hypnotic use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>4-months</time_frame>
    <description>The Patient Health Questionnaire is a 9-item screening assessment for depression severity. For each item, respondents indicate the frequency of the symptom in the past 2 weeks using the following choices: never or one day (0); 2-6 days (1); 7-11 days (2); or 12-14 days (3). Total scores range from 0 to 27, with higher scores indicating more frequent depressive symptoms. Average total scores will be compared for treatment and control populations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation)</measure>
    <time_frame>4-months</time_frame>
    <description>The tool used to directly observe resident behaviors is the Agitation Behavior Mapping Instrument. Research staff observe residents for short intervals (3 minutes per observation) and record the number of times 14 specific verbally and physically agitated behaviors occurred (up to 10 times per observation). We report the proportion of participants with no behaviors, some behaviors (1-3 ), many behaviors (4+)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Pleasure</measure>
    <time_frame>4-months</time_frame>
    <description>The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. We report the proportion of participants with any observed emotion during the structured observations after four months of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Anger</measure>
    <time_frame>4-months</time_frame>
    <description>The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants with any observed anger during observations after four months of followup.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Sadness</measure>
    <time_frame>4-months</time_frame>
    <description>The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants any sadness observed during structured observations after four months of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Alertness</measure>
    <time_frame>4-months</time_frame>
    <description>The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants with any observed alertness during structured observations after four months of followup</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Anxiety</measure>
    <time_frame>4-months</time_frame>
    <description>The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants with any observed anxiety during structured observations after four months of follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1073</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Music and Memory</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Music and Memory</intervention_name>
    <description>Music and Memory is a personalized music program in which caregivers (nursing home staff, family, or others) provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
    <arm_group_label>Music and Memory</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Nursing Homes:&#xD;
&#xD;
          -  Owned by partnering health care corporations&#xD;
&#xD;
          -  Medicare / Medicaid-certified&#xD;
&#xD;
          -  Have at least 20 eligible residents&#xD;
&#xD;
        Inclusion Criteria for Residents in Eligible Nursing Homes&#xD;
&#xD;
          -  Reside in eligible nursing home for last 90 days&#xD;
&#xD;
          -  Have advanced dementia, defined by the presence of a dementia diagnosis and moderately&#xD;
             or severely impaired daily decision-making&#xD;
&#xD;
        Exclusion Criteria for Nursing Homes:&#xD;
&#xD;
          -  recent situations that may affect implementation (for example, bad state or federal&#xD;
             quality assurance surveys, leadership turnover, or other competing demands)&#xD;
&#xD;
          -  previous use of Music and Memory&#xD;
&#xD;
        Exclusion Criteria for Residents in Eligible Nursing Homes:&#xD;
&#xD;
          -  dislikes music&#xD;
&#xD;
          -  completely deaf&#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>Vincent Mor, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brown University, School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PruittHealth</name>
      <address>
        <city>Norcross</city>
        <state>Georgia</state>
        <zip>30093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vetter Senior Living</name>
      <address>
        <city>Elkhorn</city>
        <state>Nebraska</state>
        <zip>68022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CommuniCare Terrapins Division</name>
      <address>
        <city>Blue Ash</city>
        <state>Ohio</state>
        <zip>45241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Good Samaritan Society</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>October 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <results_first_submitted>October 31, 2022</results_first_submitted>
  <results_first_submitted_qc>July 6, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 27, 2023</results_first_posted>
  <last_update_submitted>July 6, 2023</last_update_submitted>
  <last_update_submitted_qc>July 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brown University</investigator_affiliation>
    <investigator_full_name>Vincent Mor</investigator_full_name>
    <investigator_title>Florence Pirce Grant University Professor, Professor of Health Services, Policy and Practice</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 17, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03821844/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Music and Memory</title>
          <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="532"/>
                <participants group_id="P2" count="541"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="483"/>
                <participants group_id="P2" count="493"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discharged</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not present in facility at followup</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Music and Memory</title>
          <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.&#xD;
Music and Memory: Music and Memory is a personalized music program in which caregivers (nursing home staff, family, or others) provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="483"/>
            <count group_id="B2" value="493"/>
            <count group_id="B3" value="976"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79.8" spread="12.2"/>
                    <measurement group_id="B2" value="80.8" spread="12.3"/>
                    <measurement group_id="B3" value="80.3" spread="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="327"/>
                    <measurement group_id="B2" value="349"/>
                    <measurement group_id="B3" value="676"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="156"/>
                    <measurement group_id="B2" value="144"/>
                    <measurement group_id="B3" value="300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="124"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="244"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="345"/>
                    <measurement group_id="B2" value="362"/>
                    <measurement group_id="B3" value="707"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="483"/>
                    <measurement group_id="B2" value="493"/>
                    <measurement group_id="B3" value="976"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cognitive function</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Cognitively intact</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mildly impaired</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="206"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderately impaired</title>
                  <measurement_list>
                    <measurement group_id="B1" value="252"/>
                    <measurement group_id="B2" value="257"/>
                    <measurement group_id="B3" value="509"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severely impaired</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Frequency of Agitated and Aggressive Behaviors (Staff Report)</title>
        <description>The tool used to interview staff about resident behaviors is the Cohen-Mansfield Agitation Inventory. Research staff interview a nursing staff member who knows the resident well to ask how frequently 29 agitated and/or aggressive behaviors occurred in the past week. There are seven response choices for each item, anchored from never (1) to several times per hour (7). Total scores on the Cohen-Mansfield Agitation Inventory range from 29 to 203, with higher scores representing more frequent agitated and/or aggressive behaviors. Adjusted mean overall scores will be compared for treatment and control populations.</description>
        <time_frame>4-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music and Memory</title>
            <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Agitated and Aggressive Behaviors (Staff Report)</title>
          <description>The tool used to interview staff about resident behaviors is the Cohen-Mansfield Agitation Inventory. Research staff interview a nursing staff member who knows the resident well to ask how frequently 29 agitated and/or aggressive behaviors occurred in the past week. There are seven response choices for each item, anchored from never (1) to several times per hour (7). Total scores on the Cohen-Mansfield Agitation Inventory range from 29 to 203, with higher scores representing more frequent agitated and/or aggressive behaviors. Adjusted mean overall scores will be compared for treatment and control populations.</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="483"/>
                <count group_id="O2" value="493"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.67" spread="1.94"/>
                    <measurement group_id="O2" value="49.34" spread="1.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Differences-in-Differences regression (D</method>
            <param_type>marginal interaction effect</param_type>
            <param_value>1.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.38</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.37</ci_lower_limit>
            <ci_upper_limit>4.0</ci_upper_limit>
            <other_analysis_desc>Fixed effects: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, antidepressant use, antianxietal use, antipsychotic use, corporation, time from Minimum Data Set (MDS) collection to Cohen-Mansfield Agitation Inventory (CMAI) score (exclusive to CMAI model), baseline Agitation and Reactive Behavior Scale (ARBS) (exclusive to CMAI model), baseline CMAI (exclusive to ARBS and ARBS-CMAI model), indicator of baseline/follow-up score, treatment group, interaction of baseline/follow-up measure, and treatment group.&#xD;
Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, random intercept for data collector (exclusive to CMAI model), and random intercept for individual.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation)</title>
        <description>The tool used to directly observe resident behaviors is the Agitation Behavior Mapping Instrument. Research staff observe residents for short intervals (3 minutes per observation) and record the number of times 14 specific verbally and physically agitated behaviors occurred (up to 10 times per observation). Ordinal outcomes quantify the number of physical and verbal agitated behaviors that occurred during the ABMI observations. The levels of these outcomes are None (0), Some (1 - 3) and Many (4 or more) observed behaviors.</description>
        <time_frame>4-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music and Memory</title>
            <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation)</title>
          <description>The tool used to directly observe resident behaviors is the Agitation Behavior Mapping Instrument. Research staff observe residents for short intervals (3 minutes per observation) and record the number of times 14 specific verbally and physically agitated behaviors occurred (up to 10 times per observation). Ordinal outcomes quantify the number of physical and verbal agitated behaviors that occurred during the ABMI observations. The levels of these outcomes are None (0), Some (1 - 3) and Many (4 or more) observed behaviors.</description>
          <units>proportion of participants with behavior</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="483"/>
                <count group_id="O2" value="493"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.799" lower_limit="0.740" upper_limit="0.851"/>
                    <measurement group_id="O2" value="0.801" lower_limit="0.740" upper_limit="0.850"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.126" lower_limit="0.091" upper_limit="0.165"/>
                    <measurement group_id="O2" value="0.132" lower_limit="0.099" upper_limit="0.169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Many</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.075" lower_limit="0.056" upper_limit="0.101"/>
                    <measurement group_id="O2" value="0.067" lower_limit="0.049" upper_limit="0.088"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Differences-in-Differences regression (D</method>
            <param_type>marginal interaction effect</param_type>
            <param_value>0.061</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.028</ci_lower_limit>
            <ci_upper_limit>0.092</ci_upper_limit>
            <other_analysis_desc>The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models. All models adjust for resident baseline covariates, an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. The reference category for the multinomial model for each outcome is &quot;None&quot;. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Agitated and Aggressive Behaviors (Administrative Data)</title>
        <description>The Aggressive Behavior Scale is a 4-item measure describing the frequency of physical behavioral symptoms directed toward others; verbal behavioral symptoms directed toward others; other behavioral symptoms not directed toward others; and behaviors related to resisting necessary care. For each item, frequency in the past week is report as: behavior not exhibited (0); behavior occurred 1-3 days (1); behavior occurred 4-6 days (2); or behavior occurred daily (3). The Aggressive Behavior Scale ranges from 0 to 12, with higher scores indicating more frequent agitated and/or aggressive behaviors. Mean total scores will be compared for treatment and control populations.</description>
        <time_frame>4-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music and Memory</title>
            <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Agitated and Aggressive Behaviors (Administrative Data)</title>
          <description>The Aggressive Behavior Scale is a 4-item measure describing the frequency of physical behavioral symptoms directed toward others; verbal behavioral symptoms directed toward others; other behavioral symptoms not directed toward others; and behaviors related to resisting necessary care. For each item, frequency in the past week is report as: behavior not exhibited (0); behavior occurred 1-3 days (1); behavior occurred 4-6 days (2); or behavior occurred daily (3). The Aggressive Behavior Scale ranges from 0 to 12, with higher scores indicating more frequent agitated and/or aggressive behaviors. Mean total scores will be compared for treatment and control populations.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="483"/>
                <count group_id="O2" value="493"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" spread="0.08"/>
                    <measurement group_id="O2" value="0.40" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Differences-in-Differences regression (D</method>
            <param_type>Marginal Interaction Effect</param_type>
            <param_value>-0.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.10</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.30</ci_lower_limit>
            <ci_upper_limit>0.08</ci_upper_limit>
            <other_analysis_desc>Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, antidepressant use, antianxietal use, antipsychotic use, nursing home corporation, time from Minimum Data Set (MDS) collection to Cohen-Mansfield Agitation Inventory (CMAI) score (exclusive to CMAI model), baseline Agitation and Reactive Behavior Score (ARBS) (exclusive to CMAI model), baseline CMAI (exclusive to ARBS and ARBS-CMAI model), indicator of baseline/follow-up score, treatment group, interaction of baseline/follow-up measure, and treatment group.&#xD;
Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, random intercept for data collector (exclusive to CMAI model), and random intercept for individual.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antipsychotic Use</title>
        <description>Any antipsychotic use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations</description>
        <time_frame>4-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music and Memory</title>
            <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Antipsychotic Use</title>
          <description>Any antipsychotic use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations</description>
          <units>percentage of participants with use</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="483"/>
                <count group_id="O2" value="493"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2" lower_limit="23.4" upper_limit="29.0"/>
                    <measurement group_id="O2" value="29.6" lower_limit="27.2" upper_limit="32.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Differences-in-Differences regression (D</method>
            <param_type>average marginal effect</param_type>
            <param_value>-3.61</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.85</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.22</ci_lower_limit>
            <ci_upper_limit>0.00</ci_upper_limit>
            <other_analysis_desc>Variables included in the model: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, agitation and reactive behavior (ARBS) score, date of assessment, treatment group, and facility-level random effect.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antianxietal Use</title>
        <description>Any antianxietal use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Measure type of mean is chosen based on adjusted percentage with standard errors from a multilevel, difference in difference regression models</description>
        <time_frame>4-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music and Memory</title>
            <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Antianxietal Use</title>
          <description>Any antianxietal use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Measure type of mean is chosen based on adjusted percentage with standard errors from a multilevel, difference in difference regression models</description>
          <units>percentage of participants with any use</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="483"/>
                <count group_id="O2" value="493"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.8" spread="1.5"/>
                    <measurement group_id="O2" value="24.3" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Differences-in-Differences regression (D</method>
            <param_type>average marginal effect</param_type>
            <param_value>-3.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.55</ci_lower_limit>
            <ci_upper_limit>0.06</ci_upper_limit>
            <other_analysis_desc>Intention-to-treat (ITT) analysis, multilevel regression with covariates' adjustments was used to estimate impact of the resident being in a treatment vs control nursing hom on medication outcomes. Clustering at the facility level was addressed using hierarchical models.. To adjust for differences in baseline, we report the marginal time by intervention interaction. Because medication use is recorded as a binary indicator, we report the average difference between the two arms after adjustment for baseline medication use [average marginal effect (AME)].</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antidepressant Use</title>
        <description>Any antidepressant use in the past week and days of use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations</description>
        <time_frame>4-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music and Memory</title>
            <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Antidepressant Use</title>
          <description>Any antidepressant use in the past week and days of use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations</description>
          <units>percentage of participants with any use</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="483"/>
                <count group_id="O2" value="493"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.5" lower_limit="54.6" upper_limit="60.5"/>
                    <measurement group_id="O2" value="58.8" lower_limit="55.8" upper_limit="61.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Differences-in-Differences regression (D</method>
            <param_type>average marginal effect</param_type>
            <param_value>-1.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.28</ci_lower_limit>
            <ci_upper_limit>2.76</ci_upper_limit>
            <other_analysis_desc>Intention-to-treat (ITT) analysis, multilevel regression with covariates' adjustments was used to estimate impact of the resident being in a treatment vs control nursing homes on medication outcomes. Clustering at the facility level was addressed using hierarchical models. To adjust for differences in baseline, we report the marginal time by intervention interaction. Because medication use is recorded as a binary indicator, we report the average difference between the two arms after adjustment for baseline medication use [average marginal effect (AME)].</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hypnotic Use</title>
        <description>Any hypnotic use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations</description>
        <time_frame>4-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music and Memory</title>
            <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Hypnotic Use</title>
          <description>Any hypnotic use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="483"/>
                <count group_id="O2" value="493"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression</title>
        <description>The Patient Health Questionnaire is a 9-item screening assessment for depression severity. For each item, respondents indicate the frequency of the symptom in the past 2 weeks using the following choices: never or one day (0); 2-6 days (1); 7-11 days (2); or 12-14 days (3). Total scores range from 0 to 27, with higher scores indicating more frequent depressive symptoms. Average total scores will be compared for treatment and control populations.</description>
        <time_frame>4-months</time_frame>
        <population>Participants dropped from analysis if missing PHQ-9 score at baseline or followup</population>
        <group_list>
          <group group_id="O1">
            <title>Music and Memory</title>
            <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Depression</title>
          <description>The Patient Health Questionnaire is a 9-item screening assessment for depression severity. For each item, respondents indicate the frequency of the symptom in the past 2 weeks using the following choices: never or one day (0); 2-6 days (1); 7-11 days (2); or 12-14 days (3). Total scores range from 0 to 27, with higher scores indicating more frequent depressive symptoms. Average total scores will be compared for treatment and control populations.</description>
          <population>Participants dropped from analysis if missing PHQ-9 score at baseline or followup</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="479"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.09" spread="0.33"/>
                    <measurement group_id="O2" value="2.30" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Differences-in-Differences regression (D</method>
            <param_type>average marginal effect</param_type>
            <param_value>-0.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.14</ci_lower_limit>
            <ci_upper_limit>0.70</ci_upper_limit>
            <other_analysis_desc>Multilevel regression with covariates' adjustments was used to estimate the impact of the resident being in a treatment versus control nursing home on depressive symptoms.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation)</title>
        <description>The tool used to directly observe resident behaviors is the Agitation Behavior Mapping Instrument. Research staff observe residents for short intervals (3 minutes per observation) and record the number of times 14 specific verbally and physically agitated behaviors occurred (up to 10 times per observation). We report the proportion of participants with no behaviors, some behaviors (1-3 ), many behaviors (4+)</description>
        <time_frame>4-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music and Memory</title>
            <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation)</title>
          <description>The tool used to directly observe resident behaviors is the Agitation Behavior Mapping Instrument. Research staff observe residents for short intervals (3 minutes per observation) and record the number of times 14 specific verbally and physically agitated behaviors occurred (up to 10 times per observation). We report the proportion of participants with no behaviors, some behaviors (1-3 ), many behaviors (4+)</description>
          <units>proportion of participants with behavior</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="483"/>
                <count group_id="O2" value="493"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.853" lower_limit="0.799" upper_limit="0.899"/>
                    <measurement group_id="O2" value="0.899" lower_limit="0.852" upper_limit="0.935"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.120" lower_limit="0.081" upper_limit="0.166"/>
                    <measurement group_id="O2" value="0.086" lower_limit="0.056" upper_limit="0.128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Many</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.027" lower_limit="0.017" upper_limit="0.039"/>
                    <measurement group_id="O2" value="0.014" lower_limit="0.008" upper_limit="0.022"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Differences-in-Differences regression (D</method>
            <param_type>marginal interaction effect</param_type>
            <param_value>-0.001</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.030</ci_lower_limit>
            <ci_upper_limit>0.024</ci_upper_limit>
            <other_analysis_desc>The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the behaviors of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Observed Pleasure</title>
        <description>The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. We report the proportion of participants with any observed emotion during the structured observations after four months of follow-up.</description>
        <time_frame>4-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music and Memory</title>
            <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Observed Pleasure</title>
          <description>The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. We report the proportion of participants with any observed emotion during the structured observations after four months of follow-up.</description>
          <units>proportion of participants with behavior</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="483"/>
                <count group_id="O2" value="493"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.359" lower_limit="0.298" upper_limit="0.429"/>
                    <measurement group_id="O2" value="0.289" lower_limit="0.235" upper_limit="0.349"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Differences-in-Differences regression (D</method>
            <param_type>average marginal effect</param_type>
            <param_value>0.038</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.008</ci_lower_limit>
            <ci_upper_limit>0.073</ci_upper_limit>
            <other_analysis_desc>The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Observed Anger</title>
        <description>The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants with any observed anger during observations after four months of followup.</description>
        <time_frame>4-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music and Memory</title>
            <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Observed Anger</title>
          <description>The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants with any observed anger during observations after four months of followup.</description>
          <units>proportion of participants with emotion</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="483"/>
                <count group_id="O2" value="493"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.043" lower_limit="0.029" upper_limit="0.060"/>
                    <measurement group_id="O2" value="0.030" lower_limit="0.018" upper_limit="0.043"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Differences-in-Differences regression (D</method>
            <param_type>average marginal effect</param_type>
            <param_value>-0.012</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.031</ci_lower_limit>
            <ci_upper_limit>0.007</ci_upper_limit>
            <other_analysis_desc>The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Observed Sadness</title>
        <description>The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants any sadness observed during structured observations after four months of follow-up</description>
        <time_frame>4-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music and Memory</title>
            <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Observed Sadness</title>
          <description>The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants any sadness observed during structured observations after four months of follow-up</description>
          <units>proportion of participants with emotion</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="483"/>
                <count group_id="O2" value="493"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.072" lower_limit="0.046" upper_limit="0.107"/>
                    <measurement group_id="O2" value="0.061" lower_limit="0.040" upper_limit="0.095"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Differences-in-Differences regression (D</method>
            <param_type>average marginal effect</param_type>
            <param_value>-0.013</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.035</ci_lower_limit>
            <ci_upper_limit>0.008</ci_upper_limit>
            <other_analysis_desc>The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Observed Alertness</title>
        <description>The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants with any observed alertness during structured observations after four months of followup</description>
        <time_frame>4-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music and Memory</title>
            <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Observed Alertness</title>
          <description>The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants with any observed alertness during structured observations after four months of followup</description>
          <units>proportion of participants with emotion</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="483"/>
                <count group_id="O2" value="493"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.782" lower_limit="0.740" upper_limit="0.819"/>
                    <measurement group_id="O2" value="0.762" lower_limit="0.722" upper_limit="0.797"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Differences-in-Differences regression (D</method>
            <param_type>average marginal effect</param_type>
            <param_value>0.006</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.019</ci_lower_limit>
            <ci_upper_limit>0.030</ci_upper_limit>
            <other_analysis_desc>The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Observed Anxiety</title>
        <description>The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants with any observed anxiety during structured observations after four months of follow-up</description>
        <time_frame>4-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music and Memory</title>
            <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Observed Anxiety</title>
          <description>The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants with any observed anxiety during structured observations after four months of follow-up</description>
          <units>proportion of participants with emotion</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="483"/>
                <count group_id="O2" value="493"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.121" lower_limit="0.082" upper_limit="0.168"/>
                    <measurement group_id="O2" value="0.127" lower_limit="0.081" upper_limit="0.180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Differences-in-Differences regression (D</method>
            <param_type>marginal interaction effect</param_type>
            <param_value>-0.021</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.050</ci_lower_limit>
            <ci_upper_limit>0.005</ci_upper_limit>
            <other_analysis_desc>The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment vs. control NH had on the behaviors and moods of NH residents. The models were implemented separately for each mood. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction. We will refer to this estimand as the marginal interaction effect (MIE), which is sometimes known as the Difference in Differences estimand.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8-month data collection window at facility</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Music and Memory</title>
          <description>Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="532"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="541"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="532"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="541"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="532"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="541"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ellen McCreedy, PhD</name_or_title>
      <organization>Brown University</organization>
      <phone>401-863-7345</phone>
      <email>Ellen_McCreedy@brown.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03821844
org study id: R33AG057451_part1
secondary id: R33AG057451
nct id: NCT03821844
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this trial is to test the effects of a personalized music intervention (Music
      and Memory, Inc.) on agitated and aggressive behaviors for nursing home residents with
      dementia.
The purpose of this study is to conduct a parallel, pragmatic, cluster randomized control
      trial of personalized music (Music and Memory) for nursing home residents with moderate to
      severe dementia living in 54 nursing homes (27 treatment, 27 control) from 4 nursing home
      corporations. Music and Memory is a personalized music program that uses portable music
      players to deliver individualized music to people with dementia at times when agitated
      behaviors are likely.

      **This funding mechanism sponsored two parallel trials with different implementation
      strategies. In this trial, nursing home staff identify the music a resident with dementia may
      have preferred when s/he was young by asking family members and testing individual songs with
      the resident. Details of the second parallel trial conducted under this funding mechanism are
      registered under "R33AG057451_part2."**

      The aims of this study are: 1. To use a train-the-trainer model to implement the intervention
      with ongoing monitoring of the program's adoption and acceptance by nursing home residents
      with dementia; 2. To estimate the impact of Music and Memory on agitated and aggressive
      behaviors; and 3. To examine factors associated with variation in providers' adherence to the
      implementation of Music and Memory.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The investigator's primary outcome (staff report of resident agitated and aggressive behaviors) will be evaluated using a parallel design. Some secondary outcomes will be tested with a stepped wedge design.
primary purpose: Supportive Care
masking: Single (Investigator)
masking description: The principal investigator is blinded to random assignment of nursing homes to treatment or control conditions
measure: Frequency of Agitated and Aggressive Behaviors (Staff Report)
time frame: 4-months
description: The tool used to interview staff about resident behaviors is the Cohen-Mansfield Agitation Inventory. Research staff interview a nursing staff member who knows the resident well to ask how frequently 29 agitated and/or aggressive behaviors occurred in the past week. There are seven response choices for each item, anchored from never (1) to several times per hour (7). Total scores on the Cohen-Mansfield Agitation Inventory range from 29 to 203, with higher scores representing more frequent agitated and/or aggressive behaviors. Adjusted mean overall scores will be compared for treatment and control populations.
measure: Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation)
time frame: 4-months
description: The tool used to directly observe resident behaviors is the Agitation Behavior Mapping Instrument. Research staff observe residents for short intervals (3 minutes per observation) and record the number of times 14 specific verbally and physically agitated behaviors occurred (up to 10 times per observation). Ordinal outcomes quantify the number of physical and verbal agitated behaviors that occurred during the ABMI observations. The levels of these outcomes are None (0), Some (1 - 3) and Many (4 or more) observed behaviors.
measure: Frequency of Agitated and Aggressive Behaviors (Administrative Data)
time frame: 4-months
description: The Aggressive Behavior Scale is a 4-item measure describing the frequency of physical behavioral symptoms directed toward others; verbal behavioral symptoms directed toward others; other behavioral symptoms not directed toward others; and behaviors related to resisting necessary care. For each item, frequency in the past week is report as: behavior not exhibited (0); behavior occurred 1-3 days (1); behavior occurred 4-6 days (2); or behavior occurred daily (3). The Aggressive Behavior Scale ranges from 0 to 12, with higher scores indicating more frequent agitated and/or aggressive behaviors. Mean total scores will be compared for treatment and control populations.
measure: Antipsychotic Use
time frame: 4-months
description: Any antipsychotic use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations
measure: Antianxietal Use
time frame: 4-months
description: Any antianxietal use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Measure type of mean is chosen based on adjusted percentage with standard errors from a multilevel, difference in difference regression models
measure: Antidepressant Use
time frame: 4-months
description: Any antidepressant use in the past week and days of use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations
measure: Hypnotic Use
time frame: 4-months
description: Any hypnotic use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations
measure: Depression
time frame: 4-months
description: The Patient Health Questionnaire is a 9-item screening assessment for depression severity. For each item, respondents indicate the frequency of the symptom in the past 2 weeks using the following choices: never or one day (0); 2-6 days (1); 7-11 days (2); or 12-14 days (3). Total scores range from 0 to 27, with higher scores indicating more frequent depressive symptoms. Average total scores will be compared for treatment and control populations.
measure: Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation)
time frame: 4-months
description: The tool used to directly observe resident behaviors is the Agitation Behavior Mapping Instrument. Research staff observe residents for short intervals (3 minutes per observation) and record the number of times 14 specific verbally and physically agitated behaviors occurred (up to 10 times per observation). We report the proportion of participants with no behaviors, some behaviors (1-3 ), many behaviors (4+)
measure: Observed Pleasure
time frame: 4-months
description: The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. We report the proportion of participants with any observed emotion during the structured observations after four months of follow-up.
measure: Observed Anger
time frame: 4-months
description: The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants with any observed anger during observations after four months of followup.
measure: Observed Sadness
time frame: 4-months
description: The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants any sadness observed during structured observations after four months of follow-up
measure: Observed Alertness
time frame: 4-months
description: The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants with any observed alertness during structured observations after four months of followup
measure: Observed Anxiety
time frame: 4-months
description: The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants with any observed anxiety during structured observations after four months of follow-up
arm group label: Music and Memory
arm group type: Experimental
description: Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.
arm group label: Usual Care
arm group type: No Intervention
description: Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
intervention type: Behavioral
intervention name: Music and Memory
description: Music and Memory is a personalized music program in which caregivers (nursing home staff, family, or others) provide people with dementia with music playlists tailored to their personal history of music preferences.
arm group label: Music and Memory
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Vincent Mor, PhD
role: Principal Investigator
affiliation: Brown University, School of Public Health
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brown University
investigator full name: Vincent Mor
investigator title: Florence Pirce Grant University Professor, Professor of Health Services, Policy and Practice
mesh term: Alzheimer Disease
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 