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/NCT05970315</url>
    </required_header>
    <id_info>
      <org_study_id>HSC-SPH-22-0639</org_study_id>
      <nct_id>NCT05970315</nct_id>
    </id_info>
    <brief_title>Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver</brief_title>
    <official_title>Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Health Science Center, Houston</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The University of Texas Health Science Center, Houston</source>
    <oversight_info>
      <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 study is to compare patient priorities care (PPC) and usual care (UC)&#xD;
        patients to identify differences in post-encounter medication changes, treatment burden&#xD;
        (TBQ), and shared decision making in Older Patient Assessment of Chronic Illness Care&#xD;
        (OPACIC), to understand PPC participant's sense-making and communication approaches related&#xD;
        to deprescribing decisions in relation to the identified health priorities and to identify&#xD;
        and categorize adverse drug withdrawal events (ADWEs)&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 6, 2023</start_date>
    <completion_date type="Anticipated">May 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of medication changes</measure>
      <time_frame>Baseline, 3 month</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Type of medication changes</measure>
      <time_frame>Baseline, 3 month</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in patient reported treatment burden as assessed by the Treatment Burden Questionnaire (TBQ)</measure>
      <time_frame>Baseline, 3 month</time_frame>
      <description>This is a 15 item questionnaire and each is scored from 0(not a problem) to 10(big problem) for a maximum score of 150, higher number indicating more burden</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number, likelihood, and severity of adverse drug reactions (ADRs) as assessed by the Naranjo scale</measure>
      <time_frame>3 months</time_frame>
      <description>Naranjo scale is a 10 item questionnaire.Total scores range from -4 to +13; the reaction is considered definite if the score is 9 or higher, probable if 5 to 8, possible if 1 to 4, and doubtful if 0 or less.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number, likelihood, and severity of adverse drug withdrawal events (ADWEs) as assessed by the Naranjo scale</measure>
      <time_frame>3 months</time_frame>
      <description>Naranjo scale is a 10 item questionnaire.Total scores range from -4 to +13; the reaction is considered definite if the score is 9 or higher, probable if 5 to 8, possible if 1 to 4, and doubtful if 0 or less.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient perceived chronic disease care as assessed by the Older Patient Assessment of Chronic Illness Care (OPACIC) score</measure>
      <time_frame>Baseline, 3 months</time_frame>
      <description>This is a 10 item questionnaire and each is scored from 1(almost never) to 5(almost always),for a maximum score of 50 ,higher scores indicate better perceived chronic disease care</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Dementia</condition>
    <arm_group>
      <arm_group_label>PPC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>PPC</intervention_name>
      <description>Participants will have an encounter with a facilitator who will identify priorities (outcome goals and care preferences) from the dyads and transmits them in the electronic health records (EHR), and a follow-up encounter with their usual geriatric care provider to decide upon changes in their care that align with the identified priorities.</description>
      <arm_group_label>PPC</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Usual care</intervention_name>
      <description>Participants will have a geriatric clinic visit with a geriatrician that acts as their primary care provider (PCP) , in which the dyads will be encouraged by an unblinded study coordinator to ask about reducing medication burden.</description>
      <arm_group_label>Usual Care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Dementia listed as an active problem in the medical record, including Alzheimer's&#xD;
               disease, vascular dementia, frontotemporal dementia, Parkinson's dementia, Lewy body&#xD;
               disease.&#xD;
  &#xD;
            -  The functional assessment staging tool (FAST) score of 5 or lower (This will be&#xD;
               established by the patient's clinician).&#xD;
  &#xD;
            -  2 or more additional chronic conditions&#xD;
  &#xD;
            -  Takes 5 or more regular medications and&#xD;
  &#xD;
            -  A caregiver present during visits. Caregivers may include family members or unrelated&#xD;
               caregivers and will be identified through chart review and confirmed by clinician,&#xD;
               patient, and surrogate decision maker if necessary. Identified caregivers must be&#xD;
               involved in decisions and care of People living with dementia (PLWD) and routinely&#xD;
               attend clinic visits with patient&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  FAST score of 6 or more (This will be established by the patient's clinician).&#xD;
  &#xD;
            -  Significant hearing, vision, or advanced cognitive impairment that limits ability to&#xD;
               participate in PPC encounters,&#xD;
  &#xD;
            -  Caregiver is unwilling or able to participate in visits, or&#xD;
  &#xD;
            -  Deemed ineligible by their Primary care physician (PCP)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Aanand D Naik, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Texas Health Science Center, Houston</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Aanand D Naik, MD</last_name>
      <phone>713-500-9156</phone>
      <email>Aanand.Naik@uth.tmc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Erika F Patino</last_name>
      <phone>713-500-9000</phone>
      <email>Erika.F.Patino@uth.tmc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The University of Texas Health Science Center at Houston</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Aanand Naik, MD</last_name>
        <phone>713-500-9156</phone>
        <email>Aanand.Naik@uth.tmc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Erika Patino</last_name>
        <phone>713-500-9000</phone>
        <email>Erika.F.Patino@uth.tmc.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
      <investigator_full_name>Aanand Dinkar Naik</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <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/NCT05970315
  org study id: HSC-SPH-22-0639
  nct id: NCT05970315
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to compare patient priorities care (PPC) and usual care (UC)
        patients to identify differences in post-encounter medication changes, treatment burden
        (TBQ), and shared decision making in Older Patient Assessment of Chronic Illness Care
        (OPACIC), to understand PPC participant's sense-making and communication approaches related
        to deprescribing decisions in relation to the identified health priorities and to identify
        and categorize adverse drug withdrawal events (ADWEs)
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Investigator)
  measure: Number of medication changes
  time frame: Baseline, 3 month
  measure: Type of medication changes
  time frame: Baseline, 3 month
  measure: Change in patient reported treatment burden as assessed by the Treatment Burden Questionnaire (TBQ)
  time frame: Baseline, 3 month
  description: This is a 15 item questionnaire and each is scored from 0(not a problem) to 10(big problem) for a maximum score of 150, higher number indicating more burden
  measure: Number, likelihood, and severity of adverse drug reactions (ADRs) as assessed by the Naranjo scale
  time frame: 3 months
  description: Naranjo scale is a 10 item questionnaire.Total scores range from -4 to +13; the reaction is considered definite if the score is 9 or higher, probable if 5 to 8, possible if 1 to 4, and doubtful if 0 or less.
  measure: Number, likelihood, and severity of adverse drug withdrawal events (ADWEs) as assessed by the Naranjo scale
  time frame: 3 months
  description: Naranjo scale is a 10 item questionnaire.Total scores range from -4 to +13; the reaction is considered definite if the score is 9 or higher, probable if 5 to 8, possible if 1 to 4, and doubtful if 0 or less.
  measure: Patient perceived chronic disease care as assessed by the Older Patient Assessment of Chronic Illness Care (OPACIC) score
  time frame: Baseline, 3 months
  description: This is a 10 item questionnaire and each is scored from 1(almost never) to 5(almost always),for a maximum score of 50 ,higher scores indicate better perceived chronic disease care
  arm group label: PPC
  arm group type: Experimental
  arm group label: Usual Care
  arm group type: Active Comparator
  intervention type: Behavioral
  intervention name: PPC
  description: Participants will have an encounter with a facilitator who will identify priorities (outcome goals and care preferences) from the dyads and transmits them in the electronic health records (EHR), and a follow-up encounter with their usual geriatric care provider to decide upon changes in their care that align with the identified priorities.
  arm group label: PPC
  intervention type: Behavioral
  intervention name: Usual care
  description: Participants will have a geriatric clinic visit with a geriatrician that acts as their primary care provider (PCP) , in which the dyads will be encouraged by an unblinded study coordinator to ask about reducing medication burden.
  arm group label: Usual Care
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Aanand D Naik, MD
  role: Principal Investigator
  affiliation: The University of Texas Health Science Center, Houston
  last name: Aanand D Naik, MD
  phone: 713-500-9156
  email: Aanand.Naik@uth.tmc.edu
  last name: Erika F Patino
  phone: 713-500-9000
  email: Erika.F.Patino@uth.tmc.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas Health Science Center, Houston
  investigator full name: Aanand Dinkar Naik
  investigator title: Professor
  mesh term: Dementia
  sharing ipd: No