<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/NCT04484272</url>
  </required_header>
  <id_info>
    <org_study_id>IRB202000984-N</org_study_id>
    <secondary_id>5R01NR018848-03</secondary_id>
    <secondary_id>PRO00028515</secondary_id>
    <nct_id>NCT04484272</nct_id>
  </id_info>
  <brief_title>A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease</brief_title>
  <official_title>A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</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>
      The long-term goal is to reduce stress and improve pain control with less opioid use in&#xD;
      patients with sickle cell disease by promoting an intervention with self-management&#xD;
      relaxation/distraction exercises, named You Cope, We Support (YCWS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 29, 2021</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</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>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stress intensity scale</measure>
    <time_frame>Baseline through Week 8</time_frame>
    <description>This 3-item scale asks patients to report their current, least, and worst stress intensity in the past 24 hours, on a scale of 0 (no stress) to 10 (stress as bad as it could be)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">185</enrollment>
  <condition>Sickle Cell Disease</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).</intervention_name>
    <description>Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-monitoring of pain, stress, and opioid use + alerts/reminders.</intervention_name>
    <description>Self-monitoring of pain, stress, and opioid use + alerts/reminders.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  with diagnosis of SCD (e.g., HbSS, HbSC, HbS-beta-0 thalassemia, and HbS-beta+&#xD;
             thalassemia); (b) reports moderate to severe level of pain (&gt;3 on 0-10 scale) related&#xD;
             to SCD within previous 24 hours; (c) uses opioid analgesics on &quot;as needed&quot; or&#xD;
             &quot;continuous&quot; basis (d) who speaks and reads English; and (e) is 18 years of age or&#xD;
             older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  are legally blind; (b) physically unable to complete procedures; (c) previously&#xD;
             participated in our relaxation/distraction intervention feasibility study&#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>Miriam O. Ezenwa</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Victoria Evans</last_name>
    <phone>352-273-6323</phone>
    <email>torifae@ufl.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Miriam Ezenwa, PhD, RN, FAAN</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>September 13, 2022</last_update_submitted>
  <last_update_submitted_qc>September 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 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>Anemia, Sickle Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</mesh_term>
  </intervention_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/NCT04484272
org study id: IRB202000984-N
secondary id: 5R01NR018848-03
secondary id: PRO00028515
nct id: NCT04484272
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The long-term goal is to reduce stress and improve pain control with less opioid use in
      patients with sickle cell disease by promoting an intervention with self-management
      relaxation/distraction exercises, named You Cope, We Support (YCWS).
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Stress intensity scale
time frame: Baseline through Week 8
description: This 3-item scale asks patients to report their current, least, and worst stress intensity in the past 24 hours, on a scale of 0 (no stress) to 10 (stress as bad as it could be)
arm group label: Control Group
arm group type: Active Comparator
arm group label: Experimental Group
arm group type: Experimental
intervention type: Behavioral
intervention name: Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).
description: Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).
arm group label: Experimental Group
intervention type: Behavioral
intervention name: Self-monitoring of pain, stress, and opioid use + alerts/reminders.
description: Self-monitoring of pain, stress, and opioid use + alerts/reminders.
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Miriam O. Ezenwa
role: Principal Investigator
affiliation: University of Florida
last name: Victoria Evans
phone: 352-273-6323
email: torifae@ufl.edu
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Anemia, Sickle Cell
mesh term: Analgesics, Opioid
sharing ipd: No