<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/NCT02982278</url>
  </required_header>
  <id_info>
    <org_study_id>PRO 46339</org_study_id>
    <nct_id>NCT02982278</nct_id>
  </id_info>
  <brief_title>Wide Spectrum Investigation of Stroke Outcome Disparities on Multiple Levels (WISSDOM)</brief_title>
  <acronym>CINGS</acronym>
  <official_title>Wide Spectrum Investigation of Stroke Outcome Disparities on Multiple Levels (WISSDOM): Community-based Intervention Under Nurse Guidance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Heart Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research project will evaluate the relationship between cardiovascular risk factors,&#xD;
      degrees of physical and mental activity prior to the stroke, brain tissue integrity,&#xD;
      post-stroke community participation and neurological recovery after the stroke. Investigators&#xD;
      will recruit and study healthy and post stroke participants, gaining insight into the&#xD;
      possible mechanisms that explain why the adverse risk profile, which is more commonly present&#xD;
      in African-Americans than non-Hispanic Whites in the stroke belt, is translated into a less&#xD;
      favorable recovery post stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke is a common cause of disability, but not all subjects who survive a stroke are left&#xD;
      with debilitating sequelae. The human brain is able to self-repair and adapt after injury&#xD;
      through neuroplasticity, which is crucial for stroke recovery. At present, recovery cannot be&#xD;
      completely predicted from clinical stroke variables. A promising theory suggests that the&#xD;
      health status of the stroke host is as important as stroke severity for recovery. Within the&#xD;
      neurological system, health is reflected by the integrity of the brain tissue and its&#xD;
      neuronal environment, which provide the neuroplastic potential that is necessary for&#xD;
      recovery. The potential for neuroplasticity is likely variable across individuals and&#xD;
      possibly accounts for some of the differences in outcome that cannot be explained by other&#xD;
      clinical factors.&#xD;
&#xD;
      A better understanding of the relationship between stroke outcomes, host brain tissue&#xD;
      integrity and recovery environment would have immense potential to address stroke related&#xD;
      disabilities. The investigators are experts in research involving brain tissue integrity&#xD;
      using neuroimaging and recovery environment using community based participation approaches&#xD;
      involving nurse-guided community health workers (CHWs).&#xD;
&#xD;
      This research project will evaluate the relationship between cardiovascular risk factors,&#xD;
      degrees of physical and mental activity prior to the stroke, brain tissue integrity,&#xD;
      post-stroke community participation and neurological recovery after the stroke. The&#xD;
      investigators will recruit and study a biracial cohort, gaining insight into the possible&#xD;
      mechanisms that explain why the adverse risk profile, which is more commonly present in&#xD;
      African-Americans than non-Hispanic Whites in the stroke belt, is translated into a less&#xD;
      favorable recovery post stroke. If a better understanding of the underlying reasons for this&#xD;
      observation can be defined, an important first step toward eliminating this disparity can be&#xD;
      achieved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2015</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stroke Specific Quality of Life Scale</measure>
    <time_frame>3, 6, 12 months</time_frame>
    <description>Quality of Life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke Impact Scale</measure>
    <time_frame>3, 6, 12 months</time_frame>
    <description>Stroke recovery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NIH Stroke Scale</measure>
    <time_frame>0, 3, months</time_frame>
    <description>Stroke Severity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medical Outcomes Study Social Support Scale</measure>
    <time_frame>3, 6, 12 months</time_frame>
    <description>Social Support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9</measure>
    <time_frame>3, 6 12 months</time_frame>
    <description>Depression</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Stroke Self-Efficacy Scale</measure>
    <time_frame>3, 6, 12</time_frame>
    <description>Self-efficacy</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Stroke Ischemic</condition>
  <condition>Minority Health</condition>
  <arm_group>
    <arm_group_label>CINGS Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CINGS is a 12-week nurse coordinated, Community Health Worker (CHW) intervention structure. Registered Nurse (RN) developed After hospital care plan with home visits sessions will be conducted by the CHW and intermittent televideo RN interactions. After baseline assessment, participants randomized to the intervention group will have home visits, once a week for the first month, and biweekly during months two and three. follow up assessments at 3, 6, and 12-month intervals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Control group will receive usual care. Base line visit and follow up at 3, 6, and 12 months post stroke enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Community-based Intervention under Nurse Guidance after Stroke</intervention_name>
    <description>CINGS is a 12-week nurse coordinated, Community Health Worker intervention structure. Intervention home visits will be conducted by the CHW and will include home-based training in self-care and self-management strategies alongside strategies to address risk of negative stroke outcomes that will be determined once these risk factors are identified and community-engaged approaches to their resolution derived. CHW efforts will be guided via televideo interactions with nurse coordinator. During home-visits, self-reported assessments will be collected via RedCap as well as assessments collected by the CHW and research nurse (weight, blood pressure, medication adherence). After baseline, participants randomized to the intervention group will have home visits, once a week for the first month, and biweekly for the other two months, conducted by the CHW. Additionally, there will be post-intervention follow-up assessments at 3, 6, and 12-month time intervals.</description>
    <arm_group_label>CINGS Intervention</arm_group_label>
    <arm_group_label>Control</arm_group_label>
    <other_name>CINGS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  40-75 years&#xD;
&#xD;
          -  prestroke mRS score &gt;2&#xD;
&#xD;
          -  African American or White&#xD;
&#xD;
          -  Reside in Berkeley, Charleston, Dorchester, Colleton or Georgetown Counties&#xD;
&#xD;
          -  Ischemic stroke involving only one hemisphere&#xD;
&#xD;
          -  Fugl Meyer score &gt;16 at baseline or Aphasia Quotient in Western Aphasia Battery &lt;93&#xD;
&#xD;
          -  no contraindications to research MRI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary or secondary intracerebral hematoma, or subarachnoid hemorrhage, or subdural/&#xD;
             epidural hematoma; Prisoner; diagnoses of substance addiction (alcohol or illicit&#xD;
             drugs)&#xD;
&#xD;
          -  Bihemispheric acute ischemic strokes;&#xD;
&#xD;
          -  Other concomitant neurological disorders, such as brain tumor, abscess or spinal cord&#xD;
             disease affecting language or limb motor function;&#xD;
&#xD;
          -  Documented history of dementia prior to index event;&#xD;
&#xD;
          -  Patient suffered one or more recurrent stroke during the 12-month follow up period.&#xD;
&#xD;
          -  Terminal illness with life expectancy ≤ 1 year&#xD;
&#xD;
          -  Currently pregnant&#xD;
&#xD;
          -  Brain stem strokes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gayenell Magwood, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>February 25, 2021</last_update_submitted>
  <last_update_submitted_qc>February 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2021</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>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</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/NCT02982278
org study id: PRO 46339
nct id: NCT02982278
lead sponsor: 
collaborator: 
has dmc: Yes
This research project will evaluate the relationship between cardiovascular risk factors,
      degrees of physical and mental activity prior to the stroke, brain tissue integrity,
      post-stroke community participation and neurological recovery after the stroke. Investigators
      will recruit and study healthy and post stroke participants, gaining insight into the
      possible mechanisms that explain why the adverse risk profile, which is more commonly present
      in African-Americans than non-Hispanic Whites in the stroke belt, is translated into a less
      favorable recovery post stroke.
Stroke is a common cause of disability, but not all subjects who survive a stroke are left
      with debilitating sequelae. The human brain is able to self-repair and adapt after injury
      through neuroplasticity, which is crucial for stroke recovery. At present, recovery cannot be
      completely predicted from clinical stroke variables. A promising theory suggests that the
      health status of the stroke host is as important as stroke severity for recovery. Within the
      neurological system, health is reflected by the integrity of the brain tissue and its
      neuronal environment, which provide the neuroplastic potential that is necessary for
      recovery. The potential for neuroplasticity is likely variable across individuals and
      possibly accounts for some of the differences in outcome that cannot be explained by other
      clinical factors.

      A better understanding of the relationship between stroke outcomes, host brain tissue
      integrity and recovery environment would have immense potential to address stroke related
      disabilities. The investigators are experts in research involving brain tissue integrity
      using neuroimaging and recovery environment using community based participation approaches
      involving nurse-guided community health workers (CHWs).

      This research project will evaluate the relationship between cardiovascular risk factors,
      degrees of physical and mental activity prior to the stroke, brain tissue integrity,
      post-stroke community participation and neurological recovery after the stroke. The
      investigators will recruit and study a biracial cohort, gaining insight into the possible
      mechanisms that explain why the adverse risk profile, which is more commonly present in
      African-Americans than non-Hispanic Whites in the stroke belt, is translated into a less
      favorable recovery post stroke. If a better understanding of the underlying reasons for this
      observation can be defined, an important first step toward eliminating this disparity can be
      achieved.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: Stroke Specific Quality of Life Scale
time frame: 3, 6, 12 months
description: Quality of Life
measure: Stroke Impact Scale
time frame: 3, 6, 12 months
description: Stroke recovery
measure: NIH Stroke Scale
time frame: 0, 3, months
description: Stroke Severity
measure: Medical Outcomes Study Social Support Scale
time frame: 3, 6, 12 months
description: Social Support
measure: Patient Health Questionnaire-9
time frame: 3, 6 12 months
description: Depression
measure: Stroke Self-Efficacy Scale
time frame: 3, 6, 12
description: Self-efficacy
arm group label: CINGS Intervention
arm group type: Experimental
description: CINGS is a 12-week nurse coordinated, Community Health Worker (CHW) intervention structure. Registered Nurse (RN) developed After hospital care plan with home visits sessions will be conducted by the CHW and intermittent televideo RN interactions. After baseline assessment, participants randomized to the intervention group will have home visits, once a week for the first month, and biweekly during months two and three. follow up assessments at 3, 6, and 12-month intervals.
arm group label: Control
arm group type: Experimental
description: Control group will receive usual care. Base line visit and follow up at 3, 6, and 12 months post stroke enrollment.
intervention type: Behavioral
intervention name: Community-based Intervention under Nurse Guidance after Stroke
description: CINGS is a 12-week nurse coordinated, Community Health Worker intervention structure. Intervention home visits will be conducted by the CHW and will include home-based training in self-care and self-management strategies alongside strategies to address risk of negative stroke outcomes that will be determined once these risk factors are identified and community-engaged approaches to their resolution derived. CHW efforts will be guided via televideo interactions with nurse coordinator. During home-visits, self-reported assessments will be collected via RedCap as well as assessments collected by the CHW and research nurse (weight, blood pressure, medication adherence). After baseline, participants randomized to the intervention group will have home visits, once a week for the first month, and biweekly for the other two months, conducted by the CHW. Additionally, there will be post-intervention follow-up assessments at 3, 6, and 12-month time intervals.
arm group label: CINGS Intervention
arm group label: Control
other name: CINGS
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Gayenell Magwood, PhD
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
sharing ipd: No