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/NCT06024278</url>
    </required_header>
    <id_info>
      <org_study_id>22-04024661</org_study_id>
      <secondary_id>3K76AG059997-03S1</secondary_id>
      <nct_id>NCT06024278</nct_id>
    </id_info>
    <brief_title>Developing and Pilot Testing Culturally Based Educational Videos for Puerto Rican and African American Home Hospice Caregivers</brief_title>
    <official_title>Developing and Pilot Testing Culturally Based Educational Videos for Puerto Rican and African American Home Hospice Caregivers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Weill Medical College of Cornell University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>VNS Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Weill Medical College of Cornell University</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 investigators hypothesize that culturally based educational videos for Puerto Rican and&#xD;
        African American home hospice caregivers will better inform caregivers in managing symptoms,&#xD;
        preparedness, self-efficacy, and competence.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The clinical trial for this project is a cross-sectional study conducted with VNS Health&#xD;
        hospice, Hospicio Toque de Amor, and Hospicio Luz Celeste. Names of Puerto Rican and African&#xD;
        American caregivers receiving home hospice care will be referred to the study team by the&#xD;
        site leader/hospice leadership at each hospice. Demographic data will be collected from each&#xD;
        caregiver participant. Prior to showing participants the culturally tailored videos, a&#xD;
        research member will administer a set of Likert style questions developed by the research&#xD;
        team around comfort in managing symptom related issues. The same questions will be&#xD;
        administered again post video intervention. In addition, the preparedness scale, chronic pain&#xD;
        self-efficacy scale, and caregiving competence scale will be administered to participants pre&#xD;
        and post video intervention. The PI will not be involved in the administering the&#xD;
        intervention for this study. After the culturally tailored videos have been shown to the&#xD;
        participant, a research member will also conduct an open-ended interview about content,&#xD;
        reactions, attitudes, usefulness and limitations around each video. Interviews will be&#xD;
        conducted in either English and/or Spanish.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">June 5, 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in caregivers' comfort in managing symptom related issues using a Likert scale</measure>
      <time_frame>Pre-test and post-test (Day 1)</time_frame>
      <description>1 is extremely uncomfortable and 5 is very comfortable</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Caregiver Preparedness Scale</measure>
      <time_frame>Pre-test and post-test (Day 1)</time_frame>
      <description>An 8-item scale. Each question ranges from 0 (Not at all prepared) to 4 (Very well prepared). Total score can range from 0 to 32 with higher scores are indicative of feeling better prepared for the caregiving role.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Caregiving Competence Scale</measure>
      <time_frame>Pre-test and post-test (Day 1)</time_frame>
      <description>A 4-item scale. Each question ranges from 1 (Not at all competent) to 4 (Very competent)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Chronic Pain Self-Efficacy Scale</measure>
      <time_frame>Pre-test and post-test (Day 1)</time_frame>
      <description>A 22-item scale. Each question is rated on a Likert scale between 10 (very uncertain) to 100 (very certain).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Qualitative feedback on videos</measure>
      <time_frame>Post-test (Day 1)</time_frame>
      <description>Open ended interview will be conducted to obtain participant feedback around content, attitudes, usefulness and limitations of the videos.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Caregivers of Patients on Hospice Care</condition>
    <arm_group>
      <arm_group_label>Hospice Caregivers</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Culturally tailored educations videos will be administered to participants.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Caregiver educational videos</intervention_name>
      <description>The intervention will be culturally tailored education videos for caregivers receiving hospice services.</description>
      <arm_group_label>Hospice Caregivers</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Family caregivers who identify themselves as Puerto Rican or African American&#xD;
  &#xD;
            -  English and/or Spanish speaking&#xD;
  &#xD;
            -  18 year of age or older&#xD;
  &#xD;
            -  Currently receiving home hospice services with a patient&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Veerawat Phongtankuel, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Weill Medical College of Cornell University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>VNS Health</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10017</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hospicio Luz Celeste</name>
        <address>
          <city>Caguas</city>
          <zip>00725</zip>
          <country>Puerto Rico</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hospicio Toque De Amor</name>
        <address>
          <city>Manati</city>
          <zip>00674</zip>
          <country>Puerto Rico</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Puerto Rico</country>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT06024278
  org study id: 22-04024661
  secondary id: 3K76AG059997-03S1
  nct id: NCT06024278
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators hypothesize that culturally based educational videos for Puerto Rican and
        African American home hospice caregivers will better inform caregivers in managing symptoms,
        preparedness, self-efficacy, and competence.
  The clinical trial for this project is a cross-sectional study conducted with VNS Health
        hospice, Hospicio Toque de Amor, and Hospicio Luz Celeste. Names of Puerto Rican and African
        American caregivers receiving home hospice care will be referred to the study team by the
        site leader/hospice leadership at each hospice. Demographic data will be collected from each
        caregiver participant. Prior to showing participants the culturally tailored videos, a
        research member will administer a set of Likert style questions developed by the research
        team around comfort in managing symptom related issues. The same questions will be
        administered again post video intervention. In addition, the preparedness scale, chronic pain
        self-efficacy scale, and caregiving competence scale will be administered to participants pre
        and post video intervention. The PI will not be involved in the administering the
        intervention for this study. After the culturally tailored videos have been shown to the
        participant, a research member will also conduct an open-ended interview about content,
        reactions, attitudes, usefulness and limitations around each video. Interviews will be
        conducted in either English and/or Spanish.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in caregivers' comfort in managing symptom related issues using a Likert scale
  time frame: Pre-test and post-test (Day 1)
  description: 1 is extremely uncomfortable and 5 is very comfortable
  measure: Change in Caregiver Preparedness Scale
  time frame: Pre-test and post-test (Day 1)
  description: An 8-item scale. Each question ranges from 0 (Not at all prepared) to 4 (Very well prepared). Total score can range from 0 to 32 with higher scores are indicative of feeling better prepared for the caregiving role.
  measure: Change in Caregiving Competence Scale
  time frame: Pre-test and post-test (Day 1)
  description: A 4-item scale. Each question ranges from 1 (Not at all competent) to 4 (Very competent)
  measure: Change in Chronic Pain Self-Efficacy Scale
  time frame: Pre-test and post-test (Day 1)
  description: A 22-item scale. Each question is rated on a Likert scale between 10 (very uncertain) to 100 (very certain).
  measure: Qualitative feedback on videos
  time frame: Post-test (Day 1)
  description: Open ended interview will be conducted to obtain participant feedback around content, attitudes, usefulness and limitations of the videos.
  arm group label: Hospice Caregivers
  arm group type: Experimental
  description: Culturally tailored educations videos will be administered to participants.
  intervention type: Behavioral
  intervention name: Caregiver educational videos
  description: The intervention will be culturally tailored education videos for caregivers receiving hospice services.
  arm group label: Hospice Caregivers
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Veerawat Phongtankuel, MD
  role: Principal Investigator
  affiliation: Weill Medical College of Cornell University
  facility: 
  facility: 
  facility: 
  country: Puerto Rico
  country: United States
  responsible party type: Sponsor
  sharing ipd: No