<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/NCT03288194</url>
  </required_header>
  <id_info>
    <org_study_id>15-1619</org_study_id>
    <nct_id>NCT03288194</nct_id>
  </id_info>
  <brief_title>Improving Quality of Life in Heart Failure</brief_title>
  <official_title>Improving Quality of Life in Outpatients With Heart Failure: A Two-arm Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study has been designed to test the efficacy of telephone-delivered&#xD;
      Problem-Solving Treatment (PST) for improving the quality of life (QoL) in outpatients with&#xD;
      stable heart failure (HF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heart failure (HF) is the end stage of all cardiovascular diseases, and it imposes a huge&#xD;
      burden in the United States in terms of morbidity, mortality, and economic cost. Although&#xD;
      disease management programs have been developed to curb these costs and address the&#xD;
      complexities of HF management, evaluations of these programs have yielded equivocal results.&#xD;
&#xD;
      With this study the Investigators plan to: (1) to determine the feasibility of telephone&#xD;
      delivered PST for outpatients with HF and reduced QoL by obtaining estimates of yield,&#xD;
      retention, patient acceptance, and patient satisfaction; (2) to determine whether&#xD;
      telephone-delivered PST is associated with greater improvements in QoL than&#xD;
      telephone-delivered Time Management over 8 weeks; and (3) to determine whether&#xD;
      telephone-delivered PST is associated with greater reductions in depressive symptoms and/or&#xD;
      greater improvements in self-efficacy or objectively assessed daily physical activity than&#xD;
      telephone-delivered Time Management over 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2015</start_date>
  <completion_date type="Actual">April 24, 2017</completion_date>
  <primary_completion_date type="Actual">April 24, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Kansas City Cardiomyopathy Questionnaire</measure>
    <time_frame>1 month, 2 months, 3 months, 4 months, 5 months</time_frame>
    <description>The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Beck Depression Inventory</measure>
    <time_frame>1 month, 2 months, 3 months, 4 months, 5 months</time_frame>
    <description>The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Heart Failure</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Problem-Solving Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Problem-Solving Treatment is a structured, yet flexible, form of cognitive-behavioral psychotherapy intended to increase problem-solving skills.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Time Management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Time Management is a structured, yet flexible, intervention intended to increase creativity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Problem-Solving Treatment</intervention_name>
    <arm_group_label>Problem-Solving Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Time Management</intervention_name>
    <arm_group_label>Time Management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatient&#xD;
&#xD;
          -  Age &gt; 21&#xD;
&#xD;
          -  Exhibits symptoms of hear failure (NYHA Class II or III)&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) &gt;= 40%&#xD;
&#xD;
          -  Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score &lt; 60&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cannot speak English&#xD;
&#xD;
          -  Lack telephone access&#xD;
&#xD;
          -  Unwilling to be randomized, or&#xD;
&#xD;
          -  Unavailable for the study period&#xD;
&#xD;
          -  Awaiting a heart transplant (United Network for Organ Sharing Status 1A or 1B), or&#xD;
&#xD;
          -  Planned (within 6 months) cardiac surgery&#xD;
&#xD;
          -  Cognitive impairment indicative of dementia&#xD;
&#xD;
          -  Recent (3 months)&#xD;
&#xD;
               -  acute myocardial infarction,&#xD;
&#xD;
               -  cardiac decompensation, or&#xD;
&#xD;
               -  HF-related hospitalization.&#xD;
&#xD;
          -  Use intravenous inotropic medication&#xD;
&#xD;
          -  Use an assistive circulatory device&#xD;
&#xD;
          -  Significantly reduced life expectancy due to co-morbidity (e.g., malignancy)&#xD;
&#xD;
          -  Currently receiving mental health counseling;&#xD;
&#xD;
          -  A history of:&#xD;
&#xD;
               -  bipolar disorder,&#xD;
&#xD;
               -  psychosis, or&#xD;
&#xD;
               -  substance abuse/dependency&#xD;
&#xD;
          -  Severe depressive symptoms or suicidality&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan A Shaffer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>May 2, 2022</last_update_submitted>
  <last_update_submitted_qc>May 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03288194
org study id: 15-1619
nct id: NCT03288194
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research study has been designed to test the efficacy of telephone-delivered
      Problem-Solving Treatment (PST) for improving the quality of life (QoL) in outpatients with
      stable heart failure (HF).
Heart failure (HF) is the end stage of all cardiovascular diseases, and it imposes a huge
      burden in the United States in terms of morbidity, mortality, and economic cost. Although
      disease management programs have been developed to curb these costs and address the
      complexities of HF management, evaluations of these programs have yielded equivocal results.

      With this study the Investigators plan to: (1) to determine the feasibility of telephone
      delivered PST for outpatients with HF and reduced QoL by obtaining estimates of yield,
      retention, patient acceptance, and patient satisfaction; (2) to determine whether
      telephone-delivered PST is associated with greater improvements in QoL than
      telephone-delivered Time Management over 8 weeks; and (3) to determine whether
      telephone-delivered PST is associated with greater reductions in depressive symptoms and/or
      greater improvements in self-efficacy or objectively assessed daily physical activity than
      telephone-delivered Time Management over 8 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Kansas City Cardiomyopathy Questionnaire
time frame: 1 month, 2 months, 3 months, 4 months, 5 months
description: The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
measure: Change in Beck Depression Inventory
time frame: 1 month, 2 months, 3 months, 4 months, 5 months
description: The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression.
arm group label: Problem-Solving Treatment
arm group type: Experimental
description: Problem-Solving Treatment is a structured, yet flexible, form of cognitive-behavioral psychotherapy intended to increase problem-solving skills.
arm group label: Time Management
arm group type: Active Comparator
description: Time Management is a structured, yet flexible, intervention intended to increase creativity.
intervention type: Behavioral
intervention name: Problem-Solving Treatment
arm group label: Problem-Solving Treatment
intervention type: Behavioral
intervention name: Time Management
arm group label: Time Management
criteria: 
gender: All
minimum age: 21 Years
maximum age: 99 Years
healthy volunteers: No
last name: Jonathan A Shaffer, PhD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: Undecided