<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/NCT02207803</url>
  </required_header>
  <id_info>
    <org_study_id>HM20001660</org_study_id>
    <secondary_id>R21TW009746</secondary_id>
    <nct_id>NCT02207803</nct_id>
  </id_info>
  <brief_title>A Culturally Sensitive Intervention for TBI Caregivers in Latin America</brief_title>
  <official_title>A Culturally Sensitive Intervention for TBI Caregivers in Latin America</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fogarty International Center of the National Institute of Health</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Virginia Commonwealth University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Traumatic brain injury (TBI) patients in Latin America experience high levels of disability&#xD;
      and extremely poor functional outcomes, and their informal caregivers play a key role in&#xD;
      their rehabilitation and care. To improve TBI rehabilitation through stronger informal&#xD;
      caregiving, the proposed study will develop and evaluate an evidence--based and culturally&#xD;
      sensitive Transition Assistance Program for informal caregivers of patients with TBI in Latin&#xD;
      America during the patient's transition from hospital to home. This study will generate&#xD;
      findings that can provide empirically supported guidance to clinicians regarding the&#xD;
      provision of culturally tailored rehabilitation services for TBI caregivers in Latin America&#xD;
      and in the U.S.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2017</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>Supportive Care</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Zarit Burden Interview</measure>
    <time_frame>2 months post-hospital discharge</time_frame>
    <description>22-item measure of caregiver self-reported burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Only total scores are reported here.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exemplary Care Scale-Provide Subscale</measure>
    <time_frame>2 months post-hospital discharge</time_frame>
    <description>4-item measure of the patient's report of the quality of care they receive from their caregiver. Response options for each item range from 1-4, and total scores range from 4-16, with higher scores indicating a higher quality of informal care received. Only Provide subscale scores of the Exemplary Care Scale are reported here.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental Transition Assistance Program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Transition Assistance Program</intervention_name>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        TBI Patient Inclusion Criteria:&#xD;
&#xD;
          -  Will be discharged home and not to a nursing home&#xD;
&#xD;
          -  Give permission for their caregiver to participate&#xD;
&#xD;
          -  Sign an informed consent&#xD;
&#xD;
          -  Have the ability to communicate over the phone for data collection&#xD;
&#xD;
          -  Are between 18-60 years of age&#xD;
&#xD;
        Caregiver Inclusion Criteria&#xD;
&#xD;
          -  Have a telephone in the home or cellular phone and are able to talk on the phone&#xD;
&#xD;
          -  Sign an informed consent&#xD;
&#xD;
          -  Score at least a 13 on a health literacy screening tool&#xD;
&#xD;
          -  Are between 18-85 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul B. Perrin, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pontificia Universidad Javeriana Cali</name>
      <address>
        <city>Cali</city>
        <zip>0000</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidad Sur Colombiana</name>
      <address>
        <city>Neiva</city>
        <zip>0000</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute of Neurology and Neurosurgery</name>
      <address>
        <city>Mexico City</city>
        <zip>14269</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
    <country>Mexico</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <results_first_submitted>June 2, 2017</results_first_submitted>
  <results_first_submitted_qc>September 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 18, 2017</results_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brain Injuries</keyword>
  <keyword>Caregivers</keyword>
  <keyword>Intervention Studies</keyword>
  <keyword>Latin America</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 6, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT02207803/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 6, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT02207803/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Transition Assistance Program</title>
          <description>Group receiving the 5-session behavioral treatment from a clinician</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Group receiving the standard of care at the rehabilitation facility</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="125"/>
                <participants group_id="P2" count="125"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="110"/>
                <participants group_id="P2" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Transition Assistance Program</title>
          <description>Group receiving the 5-session behavioral treatment from a clinician</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Group receiving the standard of care at the rehabilitation facility</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="125"/>
            <count group_id="B2" value="125"/>
            <count group_id="B3" value="250"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="120"/>
                    <measurement group_id="B2" value="119"/>
                    <measurement group_id="B3" value="239"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="37" spread="14"/>
                    <measurement group_id="B2" value="39" spread="13"/>
                    <measurement group_id="B3" value="38" spread="14"/>
                  </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="61"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="124"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                    <measurement group_id="B2" value="125"/>
                    <measurement group_id="B3" value="250"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</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>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Colombia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Zarit Burden Interview</title>
        <description>22-item measure of caregiver self-reported burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Only total scores are reported here.</description>
        <time_frame>2 months post-hospital discharge</time_frame>
        <population>Data are from caregivers only, hence not the full sample.</population>
        <group_list>
          <group group_id="O1">
            <title>Transition Assistance Program</title>
            <description>Group receiving the 5-session behavioral treatment from a clinician</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Group receiving the standard of care at the rehabilitation facility</description>
          </group>
        </group_list>
        <measure>
          <title>Zarit Burden Interview</title>
          <description>22-item measure of caregiver self-reported burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Only total scores are reported here.</description>
          <population>Data are from caregivers only, hence not the full sample.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.41" spread="16.50"/>
                    <measurement group_id="O2" value="26.48" spread="19.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Exemplary Care Scale-Provide Subscale</title>
        <description>4-item measure of the patient's report of the quality of care they receive from their caregiver. Response options for each item range from 1-4, and total scores range from 4-16, with higher scores indicating a higher quality of informal care received. Only Provide subscale scores of the Exemplary Care Scale are reported here.</description>
        <time_frame>2 months post-hospital discharge</time_frame>
        <population>This is patient-report only at post-test, hence it does not use the full sample.</population>
        <group_list>
          <group group_id="O1">
            <title>Transition Assistance Program</title>
            <description>Group receiving the 5-session behavioral treatment from a clinician</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Group receiving the standard of care at the rehabilitation facility</description>
          </group>
        </group_list>
        <measure>
          <title>Exemplary Care Scale-Provide Subscale</title>
          <description>4-item measure of the patient's report of the quality of care they receive from their caregiver. Response options for each item range from 1-4, and total scores range from 4-16, with higher scores indicating a higher quality of informal care received. Only Provide subscale scores of the Exemplary Care Scale are reported here.</description>
          <population>This is patient-report only at post-test, hence it does not use the full sample.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.23" spread="2.89"/>
                    <measurement group_id="O2" value="14.07" spread="2.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4-month data collection window</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Transition Assistance Program</title>
          <description>Group receiving the 5-session behavioral treatment from a clinician</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Group receiving the standard of care at the rehabilitation facility</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="0" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="125"/>
              </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="125"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="125"/>
              </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>Dr. Paul Perrin</name_or_title>
      <organization>Virginia Commonwealth University</organization>
      <phone>8048273894</phone>
      <email>pperrin@vcu.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/NCT02207803
org study id: HM20001660
secondary id: R21TW009746
nct id: NCT02207803
lead sponsor: 
collaborator: 
has dmc: Yes
Traumatic brain injury (TBI) patients in Latin America experience high levels of disability
      and extremely poor functional outcomes, and their informal caregivers play a key role in
      their rehabilitation and care. To improve TBI rehabilitation through stronger informal
      caregiving, the proposed study will develop and evaluate an evidence--based and culturally
      sensitive Transition Assistance Program for informal caregivers of patients with TBI in Latin
      America during the patient's transition from hospital to home. This study will generate
      findings that can provide empirically supported guidance to clinicians regarding the
      provision of culturally tailored rehabilitation services for TBI caregivers in Latin America
      and in the U.S.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Care Provider)
measure: Zarit Burden Interview
time frame: 2 months post-hospital discharge
description: 22-item measure of caregiver self-reported burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Only total scores are reported here.
measure: Exemplary Care Scale-Provide Subscale
time frame: 2 months post-hospital discharge
description: 4-item measure of the patient's report of the quality of care they receive from their caregiver. Response options for each item range from 1-4, and total scores range from 4-16, with higher scores indicating a higher quality of informal care received. Only Provide subscale scores of the Exemplary Care Scale are reported here.
arm group label: Intervention
arm group type: Experimental
description: Experimental Transition Assistance Program
arm group label: Control
arm group type: No Intervention
description: Control
intervention type: Behavioral
intervention name: Transition Assistance Program
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Paul B. Perrin, Ph.D.
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
facility: 
facility: 
country: Colombia
country: Mexico
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 