xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05977855</url>
    </required_header>
    <id_info>
      <org_study_id>BPSDiary</org_study_id>
      <nct_id>NCT05977855</nct_id>
    </id_info>
    <brief_title>Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia ( BPSDiary )</brief_title>
    <acronym>BPSDiary</acronym>
    <official_title>Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione IRCCS San Gerardo dei Tintori</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione IRCCS San Gerardo dei Tintori</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this randomized clinical trial is to compare the efficacy of the use of a diary&#xD;
        to record behavioral and psychological symptoms of dementia (BPSD) in persons with dementia.&#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Does the use of a diary lead to a reduction of the caregiver's burden at 3 months,&#xD;
             compared with standard care?&#xD;
  &#xD;
          -  Does the use of a diary lead to a reduction of the neuropsychiatric inventory (NPI)&#xD;
             score at 3 months, compared with standard care?&#xD;
  &#xD;
          -  Does the use of a diary result in less psychotropic drugs prescribed to the patient at 3&#xD;
             months compared with standard care?&#xD;
  &#xD;
          -  Are physicians and caregivers satisfied with managing patients with the use of a diary?&#xD;
  &#xD;
          -  Does the use of a diary reduce the caregiver's stress related to BPSD at 3 months,&#xD;
             compared with standard care? Participants will be randomly assigned to either the use of&#xD;
             a diary or a control group. Caregivers in the diary arm will be asked to fill in a diary&#xD;
             with BPSD including triggers, severity, day and hour, to be analyzed by physicians to&#xD;
             prescribe appropriate pharmacological or non-pharmacological interventions. The control&#xD;
             group will receive usual care (i.e., appropriate interventions will be applied after&#xD;
             interviewing the caregiver and/or visiting the patient).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Zarit Burden Interview</measure>
      <time_frame>3 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Neuropsychiatric Inventory</measure>
      <time_frame>3 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Olanzapine equivalents</measure>
      <time_frame>3 months</time_frame>
      <description>Calculated with the Defined Daily Doses method</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction questionnaire</measure>
      <time_frame>3 months</time_frame>
      <description>A questionnaire to evaluate care-related satisfaction in caregivers and physicians</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neuropsychiatric Inventory - Caregiver Distress Scale</measure>
      <time_frame>3 months</time_frame>
      <description>Subscale of NPI-caregiver distress scale relative to the domains included in the diary</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Behavioral and Psychiatric Symptoms of Dementia</condition>
    <arm_group>
      <arm_group_label>Diary</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>BPSDiary</intervention_name>
      <description>The BPSDiary is a diary to register severity, hour, day and triggers of a number of BPSD (namely, agitation, aggression, delusions/hallucinations, insomnia, aberrant motor behavior).</description>
      <arm_group_label>Diary</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of cognitive impairment (neurodegenerative or vascular)&#xD;
  &#xD;
            -  Caregiver and patient willing to participate in the study&#xD;
  &#xD;
            -  Caregiver living with the patient or able to cover all 24 hours&#xD;
  &#xD;
            -  Presence of BPSD pertaining to the&#xD;
               hyperactivity-irritability-impulsivity-disinhibition cluster (HIDA)&#xD;
  &#xD;
            -  Signed informed consent before the beginning of the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal to consent to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Lucio Tremolizzo, MD, PhD</last_name>
      <phone>+390392333595</phone>
      <email>lucio.tremolizzo@unimib.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ospedale SS Annunziata</name>
        <address>
          <city>Chieti</city>
          <state>Abruzzo</state>
          <zip>66100</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Laura Bonanni, MD, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Laura Bonanni, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Università Sapienza</name>
        <address>
          <city>Roma</city>
          <state>Lazio</state>
          <zip>00185</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Fabrizia D'Antonio, MD, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Fabrizia D'Antonio, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Ospedale Multimedica</name>
        <address>
          <city>Castellanza</city>
          <state>Lombardia</state>
          <zip>21053</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Marta Zuffi, MD</last_name>
      </contact>
      <investigator>
        <last_name>Marta Zuffi, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Fondazione IRCCS Don Gnocchi</name>
        <address>
          <city>Milano</city>
          <state>Lombardia</state>
          <zip>20148</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Elisabetta Farina, MD</last_name>
      </contact>
      <investigator>
        <last_name>Elisabetta Farina, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Fondazione IRCCS San Gerardo dei Tintori [Recruiting]</name>
        <address>
          <city>Monza</city>
          <state>Lombardia</state>
          <zip>20900</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lucio Tremolizzo, MD, PhD</last_name>
        <phone>+390392333595</phone>
        <email>lucio.tremolizzo@unimib.it</email>
      </contact>
      <contact_backup>
        <last_name>Federico Emanuele Pozzi, MD</last_name>
        <phone>+393494113421</phone>
        <email>federicoemanuele.pozzi@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Lucio Tremolizzo, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Federico Emanuele Pozzi, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Luisa Calì, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Fondazione IRCCS Mondino</name>
        <address>
          <city>Pavia</city>
          <state>Lombardia</state>
          <zip>27100</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Alfredo Costa, MD, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Alfredo Costa, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Pia Fondazione Card. Panico</name>
        <address>
          <city>Tricase</city>
          <state>Puglia</state>
          <zip>73039</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Giancarlo Logroscino, MD, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Giancarlo Logroscino, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>AOU Careggi</name>
        <address>
          <city>Firenze</city>
          <state>Toscana</state>
          <zip>50134</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Valentina Bessi, MD, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Valentina Bessi, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Arianna Ida Altomare, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>AO Padova</name>
        <address>
          <city>Padova</city>
          <state>Veneto</state>
          <zip>MD, PhD</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Annachiara Cagnin, MD, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Annachiara Cagnin, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Behavioral and Psychiatric Symptoms of Dementia</keyword>
    <keyword>Randomized Clinical Trial</keyword>
    <keyword>Diary</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dementia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05977855
  org study id: BPSDiary
  nct id: NCT05977855
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized clinical trial is to compare the efficacy of the use of a diary
        to record behavioral and psychological symptoms of dementia (BPSD) in persons with dementia.
        The main questions it aims to answer are:
  
          -  Does the use of a diary lead to a reduction of the caregiver's burden at 3 months,
             compared with standard care?
  
          -  Does the use of a diary lead to a reduction of the neuropsychiatric inventory (NPI)
             score at 3 months, compared with standard care?
  
          -  Does the use of a diary result in less psychotropic drugs prescribed to the patient at 3
             months compared with standard care?
  
          -  Are physicians and caregivers satisfied with managing patients with the use of a diary?
  
          -  Does the use of a diary reduce the caregiver's stress related to BPSD at 3 months,
             compared with standard care? Participants will be randomly assigned to either the use of
             a diary or a control group. Caregivers in the diary arm will be asked to fill in a diary
             with BPSD including triggers, severity, day and hour, to be analyzed by physicians to
             prescribe appropriate pharmacological or non-pharmacological interventions. The control
             group will receive usual care (i.e., appropriate interventions will be applied after
             interviewing the caregiver and/or visiting the patient).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Zarit Burden Interview
  time frame: 3 months
  measure: Neuropsychiatric Inventory
  time frame: 3 months
  measure: Olanzapine equivalents
  time frame: 3 months
  description: Calculated with the Defined Daily Doses method
  measure: Satisfaction questionnaire
  time frame: 3 months
  description: A questionnaire to evaluate care-related satisfaction in caregivers and physicians
  measure: Neuropsychiatric Inventory - Caregiver Distress Scale
  time frame: 3 months
  description: Subscale of NPI-caregiver distress scale relative to the domains included in the diary
  arm group label: Diary
  arm group type: Experimental
  arm group label: Standard Care
  arm group type: No Intervention
  intervention type: Other
  intervention name: BPSDiary
  description: The BPSDiary is a diary to register severity, hour, day and triggers of a number of BPSD (namely, agitation, aggression, delusions/hallucinations, insomnia, aberrant motor behavior).
  arm group label: Diary
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lucio Tremolizzo, MD, PhD
  phone: +390392333595
  email: lucio.tremolizzo@unimib.it
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Dementia
  sharing ipd: No