<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/NCT04498975</url>
  </required_header>
  <id_info>
    <org_study_id>Hopelessness-Rurality</org_study_id>
    <nct_id>NCT04498975</nct_id>
  </id_info>
  <brief_title>Exploring Potential Associations Between Rurality and Hopelessness in IHD Patients</brief_title>
  <official_title>Exploring Potential Associations Between Rurality and Hopelessness in IHD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dordt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanford Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Avera McKennan Hospital &amp; University Health Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dordt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hopelessness is associated with 3.4 times increased risk of mortality or nonfatal myocardial&#xD;
      infarction in patients with ischemic heart disease (IHD), independent of depression.&#xD;
      Hopelessness has been identified in 27-52% of patients with IHD and can persist for up to 12&#xD;
      months after hospital discharge. Hopelessness, a negative outlook and sense of helplessness&#xD;
      toward the future, can be a temporary response to an event (state) or a habitual outlook&#xD;
      (trait). Hopelessness is associated with decreased physical functioning and lower physical&#xD;
      activity (PA) levels in individuals with IHD. Low levels of PA independently contribute to&#xD;
      increased death and adverse events in patients with IHD. Rates of PA in IHD patients continue&#xD;
      to be unacceptably low in both hospital-based cardiac rehabilitation and home settings.&#xD;
      Compounding this issue is often the symptom of hopelessness. The links among hopelessness, PA&#xD;
      and mortality and morbidity for patients with IHD remain largely unknown, especially in rural&#xD;
      and minority IHD patients. The purpose of this study is to delineate differences in&#xD;
      hopelessness between urban and rural patients with IHD, as well as between racial minority,&#xD;
      including Hispanic and Native American, and White patients with IHD. Potential mediation of&#xD;
      urbanicity and race/ethnicity by social connectedness, a key variable in rural settings, will&#xD;
      also be examined. A 6-month longitudinal study will be conducted at Sanford Heart Hospital&#xD;
      and Avera Health in Sioux Falls, South Dakota. Hopelessness will be measured using the&#xD;
      State-Trait Hopelessness Scale. The results of this study have potential to transform nursing&#xD;
      practice by providing a better understanding of hopelessness in IHD patients and informing&#xD;
      future exercise rehabilitation studies and interventions in rural and minority populations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>State and Trait levels of Hopelessness</measure>
    <time_frame>Six-month</time_frame>
    <description>State-Trait Hopelessness Scale (values range from 1-4 on both subscales with larger values meaning more hopelessness)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participation (yes/no) and Levels (frequency; vigor) of Exercise</measure>
    <time_frame>Six-month</time_frame>
    <description>CREPT measurement tool for self-reported home and hospital exercise participation (yes/no) and levels (frequency/vigor) of exercise</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">125</enrollment>
  <condition>Cardiac Disease</condition>
  <condition>Mental Health Issue</condition>
  <arm_group>
    <arm_group_label>Patients with IHD</arm_group_label>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rurality; Ethnicity; Exercise; Hopelessness</intervention_name>
    <description>Observational study exploring rurality, ethnicity, exercise and hopelessness patterns cross-sectionally and longitudinally</description>
    <arm_group_label>Patients with IHD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized individuals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Myocardial infarction or unstable angina or having undergone a percutaneous coronary&#xD;
             intervention or coronary artery bypass surgery&#xD;
&#xD;
          -  ≥ 18 years&#xD;
&#xD;
          -  planned discharge home&#xD;
&#xD;
          -  cognitive and physical ability to complete the study measures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathan Tintle</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dordt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Avera Health</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Health</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>May 17, 2021</last_update_submitted>
  <last_update_submitted_qc>May 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rurality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04498975
org study id: Hopelessness-Rurality
nct id: NCT04498975
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hopelessness is associated with 3.4 times increased risk of mortality or nonfatal myocardial
      infarction in patients with ischemic heart disease (IHD), independent of depression.
      Hopelessness has been identified in 27-52% of patients with IHD and can persist for up to 12
      months after hospital discharge. Hopelessness, a negative outlook and sense of helplessness
      toward the future, can be a temporary response to an event (state) or a habitual outlook
      (trait). Hopelessness is associated with decreased physical functioning and lower physical
      activity (PA) levels in individuals with IHD. Low levels of PA independently contribute to
      increased death and adverse events in patients with IHD. Rates of PA in IHD patients continue
      to be unacceptably low in both hospital-based cardiac rehabilitation and home settings.
      Compounding this issue is often the symptom of hopelessness. The links among hopelessness, PA
      and mortality and morbidity for patients with IHD remain largely unknown, especially in rural
      and minority IHD patients. The purpose of this study is to delineate differences in
      hopelessness between urban and rural patients with IHD, as well as between racial minority,
      including Hispanic and Native American, and White patients with IHD. Potential mediation of
      urbanicity and race/ethnicity by social connectedness, a key variable in rural settings, will
      also be examined. A 6-month longitudinal study will be conducted at Sanford Heart Hospital
      and Avera Health in Sioux Falls, South Dakota. Hopelessness will be measured using the
      State-Trait Hopelessness Scale. The results of this study have potential to transform nursing
      practice by providing a better understanding of hopelessness in IHD patients and informing
      future exercise rehabilitation studies and interventions in rural and minority populations.
observational model: Cohort
time perspective: Prospective
measure: State and Trait levels of Hopelessness
time frame: Six-month
description: State-Trait Hopelessness Scale (values range from 1-4 on both subscales with larger values meaning more hopelessness)
measure: Participation (yes/no) and Levels (frequency; vigor) of Exercise
time frame: Six-month
description: CREPT measurement tool for self-reported home and hospital exercise participation (yes/no) and levels (frequency/vigor) of exercise
arm group label: Patients with IHD
description: No intervention
intervention type: Other
intervention name: Rurality; Ethnicity; Exercise; Hopelessness
description: Observational study exploring rurality, ethnicity, exercise and hopelessness patterns cross-sectionally and longitudinally
arm group label: Patients with IHD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Nathan Tintle
role: Principal Investigator
affiliation: Dordt University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Diseases
sharing ipd: No