<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/NCT03043261</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00078272</org_study_id>
    <nct_id>NCT03043261</nct_id>
  </id_info>
  <brief_title>Effective Management of Emotional Response to Generate Well-Being Post-HF Exacerbation</brief_title>
  <acronym>EMERGE</acronym>
  <official_title>Effective Management of Emotional Response to Generate Well-Being Post-HF Exacerbation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      EMERGE is a PI-initiated feasibility study that aims to evaluate the accessibility,&#xD;
      usability, effectiveness and relevance of an integrated psycho-behavioral intervention on&#xD;
      heart failure patients in order to increase support, outreach and general well-being of these&#xD;
      patients following hospitalization due to heart failure exacerbation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2018</start_date>
  <completion_date type="Actual">April 7, 2018</completion_date>
  <primary_completion_date type="Actual">April 7, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subject retention</measure>
    <time_frame>6 month</time_frame>
    <description>Percentage of subjects who complete the intervention</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Congestive Heart Failure</condition>
  <arm_group>
    <arm_group_label>Psycho-Behavioral Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Williams LifeSkills modules which cover 10 core skills designed to improve coping skills, stress management and interpersonal relationships: 1) being aware of negative thoughts and feelings, 2) making a decision, 3) deflection skills, 4) problem solving or action skills, 5) assertion, 6) saying &quot;no&quot;, in addition to the following preventive skills: 7) speaking up, 8) listening, 9) empathy and 10) increasing positives</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Williams LifeSkills</intervention_name>
    <description>Online multi-media interactive training modules which address 10 core skills to improve coping, stress management and interpersonal relationships.</description>
    <arm_group_label>Psycho-Behavioral Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult male and female patients, age ≥ 18 hospitalized at Duke inpatient service&#xD;
             because of heart failure&#xD;
&#xD;
          -  NYHA Class ≥ II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant cognitive impairment, indicated as a mini-mental state exam (MMSE) total&#xD;
             score of 23 or lower&#xD;
&#xD;
          -  Lack of convenient internet access outside of hospital&#xD;
&#xD;
          -  Alcohol or other drug dependence/abuse within past 90 days as evaluated by review of&#xD;
             medical record and patient interview (SCID)&#xD;
&#xD;
          -  Severe physical disability (visual, sensory or motor) that may interfere with study&#xD;
             participation (assessment, online interactive learning)&#xD;
&#xD;
          -  History or presence of psychoses, bipolar disorder, and/or severe personality&#xD;
             disorders as evaluated by review of medical record and patient interview (SCID)&#xD;
&#xD;
          -  Life-threatening co-morbidity with the likelihood of 50% mortality in one year&#xD;
&#xD;
          -  Active suicidal ideations&#xD;
&#xD;
          -  Female patients of childbearing potential&#xD;
&#xD;
          -  Treatment with electroconvulsive therapy or transcranial magnetic stimulation within&#xD;
             past 90 days&#xD;
&#xD;
          -  Uncorrected hypothyroidism or hyperthyroidism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Jiang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pamela Bonner</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>May 4, 2018</last_update_submitted>
  <last_update_submitted_qc>May 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CHF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03043261
org study id: Pro00078272
nct id: NCT03043261
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
EMERGE is a PI-initiated feasibility study that aims to evaluate the accessibility,
      usability, effectiveness and relevance of an integrated psycho-behavioral intervention on
      heart failure patients in order to increase support, outreach and general well-being of these
      patients following hospitalization due to heart failure exacerbation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Subject retention
time frame: 6 month
description: Percentage of subjects who complete the intervention
arm group label: Psycho-Behavioral Intervention
arm group type: Experimental
description: Williams LifeSkills modules which cover 10 core skills designed to improve coping skills, stress management and interpersonal relationships: 1) being aware of negative thoughts and feelings, 2) making a decision, 3) deflection skills, 4) problem solving or action skills, 5) assertion, 6) saying "no", in addition to the following preventive skills: 7) speaking up, 8) listening, 9) empathy and 10) increasing positives
intervention type: Behavioral
intervention name: Williams LifeSkills
description: Online multi-media interactive training modules which address 10 core skills to improve coping, stress management and interpersonal relationships.
arm group label: Psycho-Behavioral Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wei Jiang, M.D.
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure