<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/NCT01672294</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 11-347</org_study_id>
    <nct_id>NCT01672294</nct_id>
  </id_info>
  <brief_title>Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness</brief_title>
  <official_title>Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Informal caregivers provide a majority of care for patients during serious illness. Lack of&#xD;
      preparation and completion may leave caregivers less capable of caring for a loved one or&#xD;
      making crucial decisions influencing care.&#xD;
&#xD;
      This study will examine whether a preparation and completion intervention reduces caregiver&#xD;
      anxiety, depression, anticipatory grief, and burden and improves patient quality of life and&#xD;
      health care use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose a randomized control trial to evaluate an intervention of&#xD;
      preparation and completion with Veterans and their caregivers during serious illness.&#xD;
      Specific aims are to 1) Evaluate the impact of the caregiver Outlook intervention on&#xD;
      caregiver anxiety, depression, anticipatory grief, completion, and burden; 2) Evaluate the&#xD;
      impact of the home versus in hospital, emergency department, or nursing facility; 3) Evaluate&#xD;
      the impact of the intervention session's qualitative content, examining variation associated&#xD;
      with selected demographic variables, quality of family communication, and stage of illness on&#xD;
      change.&#xD;
&#xD;
      Caregivers in the first group (&quot;Treatment&quot;, or &quot;Preparation and life completion&quot;) will meet&#xD;
      with a facilitator three times for a period of forty-five minutes each. In the first session,&#xD;
      subjects will be asked to discuss issues related to relationship life review.&#xD;
&#xD;
      In session two, participants will be asked to speak in more depth about issues such as regret&#xD;
      and forgiveness. In the final session, subjects will focus on legacy and celebration.&#xD;
      Caregivers in the second group (&quot;attention control&quot; or &quot;relaxation meditation&quot;) will meet&#xD;
      with a facilitator three times for a period of forty-five minutes each and be asked to listen&#xD;
      to a non-guided relaxation compact disk (CD) or participate in a guided relaxation exercise.&#xD;
&#xD;
      Participants in both groups will receive pre and post-test measures administered by a blinded&#xD;
      interviewer. Outcome measures will be measures by the Functional Assessment of Cancer Therapy&#xD;
      - General (FACT-G), Quality of life scale, FACIT-sp sub-scale, Anticipatory Grief Scale,&#xD;
      Caregiver Reaction Assessment, the Qual-E completion and preparation sub-scales, and patient&#xD;
      days at home.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Caregiver Anxiety</measure>
    <time_frame>Measured at baseline, 5 weeks, and 8 weeks</time_frame>
    <description>Profile of Moods States (POMS) anxiety sub-scale The anxiety sub-scale from the modified Brief Profile of Mood States (POMS),7110 a six-item measure of psychological distress. Individual items used a 5 point Likert scale (0-4). The sub-scale minimum score was 0 and maximum was 24 (more anxious ).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spirituality</measure>
    <time_frame>Measured at baseline, 5 weeks, and 8 weeks</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP) subscale. The 12-item measure assess spiritual well-being: faith, meaning, and purpose. Individual items use a 5 point likert scale (0-4). The scale minimum score is 0 (negative well being) and maximum is 48 (positive well being).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Measured at baseline, 5 weeks, and 8 weeks</time_frame>
    <description>Centers for Epidemiologic Study of Depression short form (CES-D) is a 10-item measure of depression. Items are rated on a 4 point Likert scale (0-3) with total scores ranging from 0 to 30. Higher scores indicate greater depressive symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Days of VA Hospital Use</measure>
    <time_frame>In the 6 months after randomization</time_frame>
    <description>The number of days that a patient used either the VA emergency department (ED) or was an inpatient at a VA hospital in the 6 months following randomization. Inclusion of non-VA utilization was made unpractical due to the long delay in filing for non VA reimbursement (up to 2 years). The original variable was Day AT home, defined to be 180 days minus the days in ED or inpatient hospital. This was changed to days of use due to distribution/modeling considerations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Burden</measure>
    <time_frame>Measured at baseline, 5 weeks, and 8 weeks</time_frame>
    <description>Caregiver Reaction Assessment (CRA). The Caregiver Reaction Assessment is a 24-item multidimensional instrument designed to measure a caregiver's reactions to caregiving for family members with a variety of chronic illnesses. The esteem subscale has 7 items with a 5 level Likert scale: 1=Strongly Disagree to 5=Strongly Agree. The score is the average of the 7 items ranging from a low score of 1 associated with negative reactions and high score of 5 with positive reactions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Completion</measure>
    <time_frame>Measured at baseline, 5 weeks, and 8 weeks</time_frame>
    <description>Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 3-item Life Completion subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prolonged Grief - Number of Participants With Anticipatory Grief</measure>
    <time_frame>Measured at baseline, 5 weeks, and 8 weeks</time_frame>
    <description>The Prolong Grief Disorder scale is a clinically-based diagnosis determination scale modified for this study. The components/requirements that were dropped were a) diagnosis should not be made until at least 6 months since death, and b) the disturbance is not better accounted for major depressive disorder, generalized anxiety disorder or post traumatic stress disorder. The outcome was a dichotomized variable with 1 indicating symptoms of prolonged grief are present and 0 indicating insufficient symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Preparation</measure>
    <time_frame>Measured at baseline, 5 weeks, and 8 weeks</time_frame>
    <description>Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 5-item preparation subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">286</enrollment>
  <condition>Heart Failure</condition>
  <condition>Pulmonary Disease</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>three facilitator-led end-of-life preparation and completion sessions with a facilitator with both patient and caregiver</description>
  </arm_group>
  <arm_group>
    <arm_group_label>attention control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>three facilitator led sessions of listening to a relaxation CD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Preparation and life completion</intervention_name>
    <description>Caregiver subjects will discuss life review, issues of forgiveness and heritage and legacy.</description>
    <arm_group_label>treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Attention Control</intervention_name>
    <description>Caregiver subjects will listen to a non-guided relaxation CD with facilitator.</description>
    <arm_group_label>attention control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with advanced cancer/Congestive heart failure/COPD/End stage renal disease&#xD;
             who have a primary caregiver. Caregivers of Durham VAMC patients with advanced&#xD;
             disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No caregiver present.&#xD;
&#xD;
          -  Caregiver with Cognitive impairment/inability to speak on phone/non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen E Steinhauser, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Durham VA Medical Center, Durham, NC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Durham VA Medical Center, Durham, NC</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>May 11, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <results_first_submitted>January 6, 2017</results_first_submitted>
  <results_first_submitted_qc>March 3, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 17, 2017</results_first_posted>
  <last_update_submitted>March 3, 2017</last_update_submitted>
  <last_update_submitted_qc>March 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>caregiver</keyword>
  <keyword>end of life</keyword>
  <keyword>self-disclosure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study conducted recruitment from June 2013 to October 2015. Potential patients were identified by data pulls and then medical record review as well as obtaining approval to approach from providers. Patients were approached both at select outpatient clinics at the Durham VAMC as well as being sent invitation letters with subsequent phone calls.</recruitment_details>
      <pre_assignment_details>Participant pairs (seriously-ill veteran and primary informal caregiver) were consented and then each completed a baseline interview before the dyad was randomized. Enrolled participants may be excluded if either of the pair refused to consent or did not complete a baseline.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Caregiver Outlook - Caregiver</title>
          <description>Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Intervention: Three facilitator-led preparation and life completion sessions with caregiver.&#xD;
Topics included life review, issues of forgiveness and heritage and legacy.</description>
        </group>
        <group group_id="P2">
          <title>Caregiver Outlook - Patient</title>
          <description>Intervention: Three facilitator-led preparation and life completion sessions with caregiver.&#xD;
Intervention: Three facilitator-led preparation and life completion sessions with caregiver.&#xD;
Topics included life review, issues of forgiveness and heritage and legacy.</description>
        </group>
        <group group_id="P3">
          <title>Relaxation Meditation - Caregiver</title>
          <description>Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.</description>
        </group>
        <group group_id="P4">
          <title>Relaxation Meditation - Patient</title>
          <description>Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="71"/>
                <participants group_id="P3" count="72"/>
                <participants group_id="P4" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="50"/>
                <participants group_id="P3" count="61"/>
                <participants group_id="P4" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Excluded by study</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Caregiver Outlook - Caregiver</title>
          <description>Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy.</description>
        </group>
        <group group_id="B2">
          <title>Caregiver Outlook - Patient</title>
          <description>Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy.</description>
        </group>
        <group group_id="B3">
          <title>Relaxation Meditation - Caregiver</title>
          <description>Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.</description>
        </group>
        <group group_id="B4">
          <title>Relaxation Meditation - Patient</title>
          <description>Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD..</description>
        </group>
        <group group_id="B5">
          <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="71"/>
            <count group_id="B2" value="71"/>
            <count group_id="B3" value="72"/>
            <count group_id="B4" value="72"/>
            <count group_id="B5" value="286"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.8" spread="11.32"/>
                    <measurement group_id="B2" value="66.8" spread="7.85"/>
                    <measurement group_id="B3" value="60.1" spread="12.05"/>
                    <measurement group_id="B4" value="65.4" spread="9.21"/>
                    <measurement group_id="B5" value="63.3" spread="10.59"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="67"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="141"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="69"/>
                    <measurement group_id="B5" value="145"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="68"/>
                    <measurement group_id="B4" value="72"/>
                    <measurement group_id="B5" value="277"/>
                  </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="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <description>NIH/OMB categories collapsed to: African-American\Black, Caucasian\White Other including more than 1 race, missing</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="122"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="38"/>
                    <measurement group_id="B5" value="145"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="17"/>
                  </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="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </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>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="72"/>
                    <measurement group_id="B4" value="72"/>
                    <measurement group_id="B5" value="286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dyad Relationship</title>
          <description>Respective relationship of participant to other dyad in pair.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Spouse</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="53"/>
                    <measurement group_id="B4" value="53"/>
                    <measurement group_id="B5" value="210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adult Child</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sibling</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary Diagnosis of Veteran</title>
          <description>Primary life-limiting diagnosis of Veteran patient</description>
          <population>Primary diagnosis of veteran only collected from patient half of dyad, which =143</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Cancer</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B4" value="52"/>
                    <measurement group_id="B5" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Congestive Heart Failure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chronic obstructive pulmonary disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End Stage Renal Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiple Qualifying Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>HS or less</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="31"/>
                    <measurement group_id="B5" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some College</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>College Degree</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Graduate Work or Degree</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Finances</title>
          <description>Self-reported household finances by participant</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Difficulty paying bills</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Money to pay bills, cut back on things</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enough to pay bills, little extras</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="30"/>
                    <measurement group_id="B5" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>enough to pay bills and special things</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employment</title>
          <description>Self-reported employment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Working Full or Part Time</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Retired/Not Working</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="40"/>
                    <measurement group_id="B5" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Disabled</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-rated Quality of Health</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Excellent</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Good</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fair</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poor</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="34"/>
                    <measurement group_id="B5" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years of caregiving given or received</title>
          <description>Self-reported years spent caregiving or years received caregiving</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.6" spread="5.6"/>
                    <measurement group_id="B2" value="5.2" spread="5.95"/>
                    <measurement group_id="B3" value="3.7" spread="4.06"/>
                    <measurement group_id="B4" value="3.4" spread="4.2"/>
                    <measurement group_id="B5" value="4.2" spread="5.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Hours patient requires assistance</title>
          <description>Self-reported number of hours patient requires assistance</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="71"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="72"/>
                    <count group_id="B4" value="72"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.4" spread="1.24"/>
                    <measurement group_id="B2" value="2.3" spread="1.34"/>
                    <measurement group_id="B3" value="2.3" spread="1.2"/>
                    <measurement group_id="B4" value="2.1" spread="1.25"/>
                    <measurement group_id="B5" value="2.3" spread="1.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Caregiver Anxiety</title>
        <description>Profile of Moods States (POMS) anxiety sub-scale The anxiety sub-scale from the modified Brief Profile of Mood States (POMS),7110 a six-item measure of psychological distress. Individual items used a 5 point Likert scale (0-4). The sub-scale minimum score was 0 and maximum was 24 (more anxious ).</description>
        <time_frame>Measured at baseline, 5 weeks, and 8 weeks</time_frame>
        <population>Comparing Caregiver anxiety levels between the Outlook and the Relaxation meditation arm. Differences in numbers analyzed versus group totals due to missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Caregiver Outlook - Caregiver</title>
            <description>Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).</description>
          </group>
          <group group_id="O2">
            <title>Relaxation Meditation - Caregiver</title>
            <description>Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).</description>
          </group>
        </group_list>
        <measure>
          <title>Caregiver Anxiety</title>
          <description>Profile of Moods States (POMS) anxiety sub-scale The anxiety sub-scale from the modified Brief Profile of Mood States (POMS),7110 a six-item measure of psychological distress. Individual items used a 5 point Likert scale (0-4). The sub-scale minimum score was 0 and maximum was 24 (more anxious ).</description>
          <population>Comparing Caregiver anxiety levels between the Outlook and the Relaxation meditation arm. Differences in numbers analyzed versus group totals due to missing data.</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="71"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" spread="5.3"/>
                    <measurement group_id="O2" value="7.3" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 week follow up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="5.2"/>
                    <measurement group_id="O2" value="5.4" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 week follow up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" spread="5.7"/>
                    <measurement group_id="O2" value="6.4" spread="5.1"/>
                  </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>
            <groups_desc>Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.511</p_value>
            <p_value_desc>Between Outlook Intervention and Attention Control caregivers at 5 weeks</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.5376</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.0776</ci_lower_limit>
            <ci_upper_limit>2.1528</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6348</p_value>
            <p_value_desc>Between Outlook Intervention and Attention Control caregivers at 8 weeks</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.4275</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3505</ci_lower_limit>
            <ci_upper_limit>2.2055</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Spirituality</title>
        <description>Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP) subscale. The 12-item measure assess spiritual well-being: faith, meaning, and purpose. Individual items use a 5 point likert scale (0-4). The scale minimum score is 0 (negative well being) and maximum is 48 (positive well being).</description>
        <time_frame>Measured at baseline, 5 weeks, and 8 weeks</time_frame>
        <population>Comparing spiritual well being levels between the Outlook and the Relaxation meditation arms, Caregivers only.</population>
        <group_list>
          <group group_id="O1">
            <title>Caregiver Outlook - Caregiver</title>
            <description>Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).</description>
          </group>
          <group group_id="O2">
            <title>Relaxation Meditation - Caregiver</title>
            <description>Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).</description>
          </group>
        </group_list>
        <measure>
          <title>Spirituality</title>
          <description>Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP) subscale. The 12-item measure assess spiritual well-being: faith, meaning, and purpose. Individual items use a 5 point likert scale (0-4). The scale minimum score is 0 (negative well being) and maximum is 48 (positive well being).</description>
          <population>Comparing spiritual well being levels between the Outlook and the Relaxation meditation arms, Caregivers only.</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="71"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.4" spread="9.0"/>
                    <measurement group_id="O2" value="37.3" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 week</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.1" spread="8.0"/>
                    <measurement group_id="O2" value="37.3" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 week</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.3" spread="8.3"/>
                    <measurement group_id="O2" value="36.6" spread="7.6"/>
                  </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>
            <groups_desc>Comparison at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5225</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.6836</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.4278</ci_lower_limit>
            <ci_upper_limit>2.7950</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison at 8 weeks. Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1972</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.2764</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6728</ci_lower_limit>
            <ci_upper_limit>3.2257</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression</title>
        <description>Centers for Epidemiologic Study of Depression short form (CES-D) is a 10-item measure of depression. Items are rated on a 4 point Likert scale (0-3) with total scores ranging from 0 to 30. Higher scores indicate greater depressive symptoms</description>
        <time_frame>Measured at baseline, 5 weeks, and 8 weeks</time_frame>
        <population>Primary and secondary results are comparing caregiver scores in the two arms, not patient arms.</population>
        <group_list>
          <group group_id="O1">
            <title>Caregiver Outlook - Caregiver</title>
            <description>Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).</description>
          </group>
          <group group_id="O2">
            <title>Relaxation Meditation - Caregiver</title>
            <description>Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).</description>
          </group>
        </group_list>
        <measure>
          <title>Depression</title>
          <description>Centers for Epidemiologic Study of Depression short form (CES-D) is a 10-item measure of depression. Items are rated on a 4 point Likert scale (0-3) with total scores ranging from 0 to 30. Higher scores indicate greater depressive symptoms</description>
          <population>Primary and secondary results are comparing caregiver scores in the two arms, not patient arms.</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="71"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" spread="6.6"/>
                    <measurement group_id="O2" value="8.8" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" spread="6.8"/>
                    <measurement group_id="O2" value="8.0" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" spread="6.2"/>
                    <measurement group_id="O2" value="9.0" spread="6.4"/>
                  </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>
            <groups_desc>Between Outlook Intervention caregivers and active control caregivers at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.3332</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.9358</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9726</ci_lower_limit>
            <ci_upper_limit>2.8443</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note - Missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3842</p_value>
            <p_value_desc>Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.6929</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8783</ci_lower_limit>
            <ci_upper_limit>2.2642</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Days of VA Hospital Use</title>
        <description>The number of days that a patient used either the VA emergency department (ED) or was an inpatient at a VA hospital in the 6 months following randomization. Inclusion of non-VA utilization was made unpractical due to the long delay in filing for non VA reimbursement (up to 2 years). The original variable was Day AT home, defined to be 180 days minus the days in ED or inpatient hospital. This was changed to days of use due to distribution/modeling considerations.</description>
        <time_frame>In the 6 months after randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Caregiver Outlook - Patient</title>
            <description>Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).</description>
          </group>
          <group group_id="O2">
            <title>Relaxation Meditation - Patient</title>
            <description>Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Days of VA Hospital Use</title>
          <description>The number of days that a patient used either the VA emergency department (ED) or was an inpatient at a VA hospital in the 6 months following randomization. Inclusion of non-VA utilization was made unpractical due to the long delay in filing for non VA reimbursement (up to 2 years). The original variable was Day AT home, defined to be 180 days minus the days in ED or inpatient hospital. This was changed to days of use due to distribution/modeling considerations.</description>
          <units>Days in VA hospital or ER</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="11.8"/>
                    <measurement group_id="O2" value="4.4" spread="9.6"/>
                  </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 or Other</non_inferiority_type>
            <p_value>0.8748</p_value>
            <method>Standard negative binomial with offset</method>
            <param_type>expected change in difference in logs</param_type>
            <param_value>0.0593</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6784</ci_lower_limit>
            <ci_upper_limit>0.797</ci_upper_limit>
            <estimate_desc>The expected change in the difference of the logs of expected Days in VA inpatient care or ED.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Caregiver Burden</title>
        <description>Caregiver Reaction Assessment (CRA). The Caregiver Reaction Assessment is a 24-item multidimensional instrument designed to measure a caregiver's reactions to caregiving for family members with a variety of chronic illnesses. The esteem subscale has 7 items with a 5 level Likert scale: 1=Strongly Disagree to 5=Strongly Agree. The score is the average of the 7 items ranging from a low score of 1 associated with negative reactions and high score of 5 with positive reactions.</description>
        <time_frame>Measured at baseline, 5 weeks, and 8 weeks</time_frame>
        <population>Comparing Caregiver reaction assessment scores between the Outlook Intervention and the Relaxation Meditation arm.Differences in numbers analyzed versus group totals due to missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Caregiver Outlook - Caregiver</title>
            <description>Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).</description>
          </group>
          <group group_id="O2">
            <title>Relaxation Meditation - Caregiver</title>
            <description>Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).</description>
          </group>
        </group_list>
        <measure>
          <title>Caregiver Burden</title>
          <description>Caregiver Reaction Assessment (CRA). The Caregiver Reaction Assessment is a 24-item multidimensional instrument designed to measure a caregiver's reactions to caregiving for family members with a variety of chronic illnesses. The esteem subscale has 7 items with a 5 level Likert scale: 1=Strongly Disagree to 5=Strongly Agree. The score is the average of the 7 items ranging from a low score of 1 associated with negative reactions and high score of 5 with positive reactions.</description>
          <population>Comparing Caregiver reaction assessment scores between the Outlook Intervention and the Relaxation Meditation arm.Differences in numbers analyzed versus group totals due to missing data.</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="0.6"/>
                    <measurement group_id="O2" value="4.2" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 week</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="0.6"/>
                    <measurement group_id="O2" value="4.2" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 week</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="0.6"/>
                    <measurement group_id="O2" value="4.1" spread="0.6"/>
                  </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>
            <groups_desc>Between Outlook Intervention caregivers and active control caregivers at 5 weeks.&#xD;
Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7687</p_value>
            <p_value_desc>Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 5 weeks</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.01777</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1372</ci_lower_limit>
            <ci_upper_limit>0.1017</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9863</p_value>
            <p_value_desc>Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.00087</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1003</ci_lower_limit>
            <ci_upper_limit>0.09861</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Caregiver Completion</title>
        <description>Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 3-item Life Completion subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).</description>
        <time_frame>Measured at baseline, 5 weeks, and 8 weeks</time_frame>
        <population>Comparing life completion scores between the Outlook Intervention and the Relaxation meditation arm, caregivers only. Differences in numbers analyzed versus group totals due to missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Caregiver Outlook - Caregiver</title>
            <description>Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).</description>
          </group>
          <group group_id="O2">
            <title>Relaxation Meditation - Caregiver</title>
            <description>Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).</description>
          </group>
        </group_list>
        <measure>
          <title>Caregiver Completion</title>
          <description>Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 3-item Life Completion subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).</description>
          <population>Comparing life completion scores between the Outlook Intervention and the Relaxation meditation arm, caregivers only. Differences in numbers analyzed versus group totals due to missing data.</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="70"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="0.8"/>
                    <measurement group_id="O2" value="2.8" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Week</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="0.9"/>
                    <measurement group_id="O2" value="2.6" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Week</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="1.0"/>
                    <measurement group_id="O2" value="2.7" spread="0.8"/>
                  </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>
            <groups_desc>At 5 weeks - Completion subscale</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9221</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.01166</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2475</ci_lower_limit>
            <ci_upper_limit>0.2241</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison at 8 week time point Note- Missing first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 week.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3249</p_value>
            <p_value_desc>Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.1154</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3466</ci_lower_limit>
            <ci_upper_limit>0.1158</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prolonged Grief - Number of Participants With Anticipatory Grief</title>
        <description>The Prolong Grief Disorder scale is a clinically-based diagnosis determination scale modified for this study. The components/requirements that were dropped were a) diagnosis should not be made until at least 6 months since death, and b) the disturbance is not better accounted for major depressive disorder, generalized anxiety disorder or post traumatic stress disorder. The outcome was a dichotomized variable with 1 indicating symptoms of prolonged grief are present and 0 indicating insufficient symptoms.</description>
        <time_frame>Measured at baseline, 5 weeks, and 8 weeks</time_frame>
        <population>Number of participants indicating prolonged grief across the Outlook Intervention and the Relaxation meditation arm, caregivers only. Only six percent of the sample qualified as having prolonged grief, at baseline. Therefore there was not sufficient data for statistical modeling.</population>
        <group_list>
          <group group_id="O1">
            <title>Caregiver Outlook - Caregiver</title>
            <description>Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).</description>
          </group>
          <group group_id="O2">
            <title>Relaxation Meditation - Caregiver</title>
            <description>Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).</description>
          </group>
        </group_list>
        <measure>
          <title>Prolonged Grief - Number of Participants With Anticipatory Grief</title>
          <description>The Prolong Grief Disorder scale is a clinically-based diagnosis determination scale modified for this study. The components/requirements that were dropped were a) diagnosis should not be made until at least 6 months since death, and b) the disturbance is not better accounted for major depressive disorder, generalized anxiety disorder or post traumatic stress disorder. The outcome was a dichotomized variable with 1 indicating symptoms of prolonged grief are present and 0 indicating insufficient symptoms.</description>
          <population>Number of participants indicating prolonged grief across the Outlook Intervention and the Relaxation meditation arm, caregivers only. Only six percent of the sample qualified as having prolonged grief, at baseline. Therefore there was not sufficient data for statistical modeling.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 week</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 week</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Caregiver Preparation</title>
        <description>Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 5-item preparation subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).</description>
        <time_frame>Measured at baseline, 5 weeks, and 8 weeks</time_frame>
        <population>Comparing preparation scores between the Outlook Intervention and the Relaxation meditation arm, caregivers only. Two scale items were inadvertently left out initially. Items were added back in when omission was noted. However, the large number of missing makes analysis inappropriate.</population>
        <group_list>
          <group group_id="O1">
            <title>Caregiver Outlook - Caregiver</title>
            <description>Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).</description>
          </group>
          <group group_id="O2">
            <title>Relaxation Meditation - Caregiver</title>
            <description>Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).</description>
          </group>
        </group_list>
        <measure>
          <title>Caregiver Preparation</title>
          <description>Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 5-item preparation subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).</description>
          <population>Comparing preparation scores between the Outlook Intervention and the Relaxation meditation arm, caregivers only. Two scale items were inadvertently left out initially. Items were added back in when omission was noted. However, the large number of missing makes analysis inappropriate.</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="36"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="0.7"/>
                    <measurement group_id="O2" value="2.4" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Week</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="0.8"/>
                    <measurement group_id="O2" value="2.7" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Week</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="0.8"/>
                    <measurement group_id="O2" value="2.6" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During time of study participation, 8 weeks per participant. Adverse events were collected both systematically, by asking of events at each time point, and non-systematically.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Caregiver Outlook - Caregiver</title>
          <description>Intervention: Three facilitator-led sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy.</description>
        </group>
        <group group_id="E2">
          <title>Caregiver Outlook - Patient</title>
          <description>Patients of the caregivers in the Outlook Intervention arm.</description>
        </group>
        <group group_id="E3">
          <title>Relaxation Meditation - Caregiver</title>
          <description>Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.</description>
        </group>
        <group group_id="E4">
          <title>Relaxation Meditation - Patient</title>
          <description>Patients of the caregivers in the Attention Control arm.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="71"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastro-Intestinal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Neoplasm-death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Surgery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="71"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Multiple/general</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vascular/blood</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="71"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Karen Steinhauser, PhD</name_or_title>
      <organization>VA HSRD Durham VA Medical Center</organization>
      <phone>9196682148</phone>
      <email>karen.steinhauser@va.gov</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/NCT01672294
org study id: IIR 11-347
nct id: NCT01672294
lead sponsor: 
has dmc: No
Informal caregivers provide a majority of care for patients during serious illness. Lack of
      preparation and completion may leave caregivers less capable of caring for a loved one or
      making crucial decisions influencing care.

      This study will examine whether a preparation and completion intervention reduces caregiver
      anxiety, depression, anticipatory grief, and burden and improves patient quality of life and
      health care use.
The investigators propose a randomized control trial to evaluate an intervention of
      preparation and completion with Veterans and their caregivers during serious illness.
      Specific aims are to 1) Evaluate the impact of the caregiver Outlook intervention on
      caregiver anxiety, depression, anticipatory grief, completion, and burden; 2) Evaluate the
      impact of the home versus in hospital, emergency department, or nursing facility; 3) Evaluate
      the impact of the intervention session's qualitative content, examining variation associated
      with selected demographic variables, quality of family communication, and stage of illness on
      change.

      Caregivers in the first group ("Treatment", or "Preparation and life completion") will meet
      with a facilitator three times for a period of forty-five minutes each. In the first session,
      subjects will be asked to discuss issues related to relationship life review.

      In session two, participants will be asked to speak in more depth about issues such as regret
      and forgiveness. In the final session, subjects will focus on legacy and celebration.
      Caregivers in the second group ("attention control" or "relaxation meditation") will meet
      with a facilitator three times for a period of forty-five minutes each and be asked to listen
      to a non-guided relaxation compact disk (CD) or participate in a guided relaxation exercise.

      Participants in both groups will receive pre and post-test measures administered by a blinded
      interviewer. Outcome measures will be measures by the Functional Assessment of Cancer Therapy
      - General (FACT-G), Quality of life scale, FACIT-sp sub-scale, Anticipatory Grief Scale,
      Caregiver Reaction Assessment, the Qual-E completion and preparation sub-scales, and patient
      days at home.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Caregiver Anxiety
time frame: Measured at baseline, 5 weeks, and 8 weeks
description: Profile of Moods States (POMS) anxiety sub-scale The anxiety sub-scale from the modified Brief Profile of Mood States (POMS),7110 a six-item measure of psychological distress. Individual items used a 5 point Likert scale (0-4). The sub-scale minimum score was 0 and maximum was 24 (more anxious ).
measure: Spirituality
time frame: Measured at baseline, 5 weeks, and 8 weeks
description: Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP) subscale. The 12-item measure assess spiritual well-being: faith, meaning, and purpose. Individual items use a 5 point likert scale (0-4). The scale minimum score is 0 (negative well being) and maximum is 48 (positive well being).
measure: Depression
time frame: Measured at baseline, 5 weeks, and 8 weeks
description: Centers for Epidemiologic Study of Depression short form (CES-D) is a 10-item measure of depression. Items are rated on a 4 point Likert scale (0-3) with total scores ranging from 0 to 30. Higher scores indicate greater depressive symptoms
measure: Patient Days of VA Hospital Use
time frame: In the 6 months after randomization
description: The number of days that a patient used either the VA emergency department (ED) or was an inpatient at a VA hospital in the 6 months following randomization. Inclusion of non-VA utilization was made unpractical due to the long delay in filing for non VA reimbursement (up to 2 years). The original variable was Day AT home, defined to be 180 days minus the days in ED or inpatient hospital. This was changed to days of use due to distribution/modeling considerations.
measure: Caregiver Burden
time frame: Measured at baseline, 5 weeks, and 8 weeks
description: Caregiver Reaction Assessment (CRA). The Caregiver Reaction Assessment is a 24-item multidimensional instrument designed to measure a caregiver's reactions to caregiving for family members with a variety of chronic illnesses. The esteem subscale has 7 items with a 5 level Likert scale: 1=Strongly Disagree to 5=Strongly Agree. The score is the average of the 7 items ranging from a low score of 1 associated with negative reactions and high score of 5 with positive reactions.
measure: Caregiver Completion
time frame: Measured at baseline, 5 weeks, and 8 weeks
description: Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 3-item Life Completion subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).
measure: Prolonged Grief - Number of Participants With Anticipatory Grief
time frame: Measured at baseline, 5 weeks, and 8 weeks
description: The Prolong Grief Disorder scale is a clinically-based diagnosis determination scale modified for this study. The components/requirements that were dropped were a) diagnosis should not be made until at least 6 months since death, and b) the disturbance is not better accounted for major depressive disorder, generalized anxiety disorder or post traumatic stress disorder. The outcome was a dichotomized variable with 1 indicating symptoms of prolonged grief are present and 0 indicating insufficient symptoms.
measure: Caregiver Preparation
time frame: Measured at baseline, 5 weeks, and 8 weeks
description: Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 5-item preparation subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).
arm group label: treatment
arm group type: Experimental
description: three facilitator-led end-of-life preparation and completion sessions with a facilitator with both patient and caregiver
arm group label: attention control
arm group type: Active Comparator
description: three facilitator led sessions of listening to a relaxation CD.
intervention type: Other
intervention name: Preparation and life completion
description: Caregiver subjects will discuss life review, issues of forgiveness and heritage and legacy.
arm group label: treatment
intervention type: Other
intervention name: Attention Control
description: Caregiver subjects will listen to a non-guided relaxation CD with facilitator.
arm group label: attention control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Karen E Steinhauser, PhD
role: Principal Investigator
affiliation: Durham VA Medical Center, Durham, NC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 