<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/NCT04417673</url>
  </required_header>
  <id_info>
    <org_study_id>999920125</org_study_id>
    <secondary_id>20-HG-N125</secondary_id>
    <nct_id>NCT04417673</nct_id>
  </id_info>
  <brief_title>Living With Sickle Cell Disease in the COVID-19 Pandemic</brief_title>
  <official_title>A Longitudinal Survey Study on Living With Sickle Cell Disease in the COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Human Genome Research Institute (NHGRI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Sickle cell disease (SCD) is a chronic illness. It affects about 100,000 people in the United&#xD;
      States. People with SCD have red blood cells that are sickle-shaped and impaired in their&#xD;
      function. This results in a lifetime of complications that affect every organ system. People&#xD;
      with SCD also are at greater risk for respiratory infections and lung problems. Researchers&#xD;
      want to study how this population s stress, anxiety, fear, pain, sleep, and health care use&#xD;
      are being affected by the COVID-19 pandemic.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To study the extent and impact of life changes induced by the COVID-19 pandemic on people&#xD;
      living with SCD in the U.S.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People age 18 and older with SCD who live in the U.S.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will complete a survey online. The questions will focus on the following:&#xD;
&#xD;
      Medical history&#xD;
&#xD;
      Mental and physical health&#xD;
&#xD;
      Demographics&#xD;
&#xD;
      Stress&#xD;
&#xD;
      Resilience&#xD;
&#xD;
      Health care use&#xD;
&#xD;
      COVID-19&#xD;
&#xD;
      Beliefs about medical mistrust and participation in research.&#xD;
&#xD;
      At the end of the survey, participants will be asked if they would like to take the survey&#xD;
      again in the future. If they reply &quot;yes,&quot; then they will be contacted by the study team in&#xD;
      6-9 months to take the survey again. They may complete the survey again in 6-8 months, 12-15&#xD;
      months, and 18-21 months.&#xD;
&#xD;
      The survey should take less than 40 minutes to complete.&#xD;
&#xD;
      Participants' data will be coded to protect their privacy. The coded data may be shared with&#xD;
      other researchers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Description:&#xD;
&#xD;
      Longitudinal online survey of adults living with sickle cell disease (SCD) in the United&#xD;
      States. The objective of the study is to examine the extent and impact of life changes&#xD;
      induced by the COVID-19 pandemic on individuals living with SCD. It is our hypotheses that&#xD;
      adults living with SCD will be adversely impacted by COVID-19 in terms of stress, anxiety,&#xD;
      coping and sleep. Individuals living with SCD will have higher fear, isolation, anxiety and&#xD;
      stress if they have higher clinical severity. In-person healthcare utilization for&#xD;
      individuals with SCD will be reduced during the COVID-19 pandemic. Virtual healthcare&#xD;
      utilization will increase for SCD individuals but satisfaction with healthcare quality will&#xD;
      decrease.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Primary Objective: The primary objective of the study is to examine the extent and impact of&#xD;
      life changes induced by the COVID-19 pandemic on individuals living with sickle cell disease&#xD;
      (SCD). These objectives are: (1) To assess how the COVID-19 pandemic affects the&#xD;
      psychological well-being of individuals living with SCD; (2) To examine the association&#xD;
      between clinical severity of SCD and an individual s response to the COVID-19 pandemic; (3)&#xD;
      To investigate whether news and other media consumption during the COVID-19 pandemic&#xD;
      influence individual psychological well-being; (4) To determine the extent of COVID-19&#xD;
      induced trauma in individuals living with SCD, and its effect on health behaviors and&#xD;
      psychological well-being; (5) To investigate the impact of the COVID-19 pandemic on&#xD;
      healthcare utilization for SCD individuals.&#xD;
&#xD;
      Secondary Objectives: Our secondary objectives broadly examine the attitudes and viewpoints&#xD;
      of individuals with SCD on issues of trust and the future of medical advancements for&#xD;
      COVID-19 treatment(s). These will be examined in conjunction with the primary objectives and&#xD;
      are: (1) To examine the role that medical and government mistrust may have on the experiences&#xD;
      and behaviors of individuals with SCD during the pandemic; (2) To assess community attitudes&#xD;
      towards clinical trials for COVID-19.&#xD;
&#xD;
      Endpoints:&#xD;
&#xD;
      The endpoints for the study are divided into psychosocial measures as well as physical&#xD;
      measures and are: (1) Stress; (2) Anxiety; (3) Depressive symptomology; (4) Sleep; (5) Pain&#xD;
      episodes and clinical severity; (6) Healthcare utilization (primary care, emergency&#xD;
&#xD;
      department, telemedicine, other). The secondary endpoint is an examination of the receptivity&#xD;
      of SCD individuals to future health recommendations and medical treatment(s).&#xD;
&#xD;
      Study Population: Sample up to 1000 adults living with SCD in the United States, 18 years of&#xD;
      age or older.&#xD;
&#xD;
      Description of Sites/Facilities Enrolling Participants:&#xD;
&#xD;
      Two cohorts will be recruited for this study: (1) Participants in the INSIGHTS study&#xD;
      (NCT02156102) (2) Participants recruited by Sickle Cell 101 and/or from the NIH Study&#xD;
      (NCT01633021), and/or from other advocacy groups or doctor s offices. Sickle Cell 101 (SC101)&#xD;
      is a Silicon Valley-based non-profit organization that specializes in sickle cell education&#xD;
      for the patients, caregivers, healthcare professionals, and other key stakeholders affected&#xD;
      by sickle cell disease and trait globally.&#xD;
&#xD;
      Study Duration: Proposed enrollment opening June 1, 2020 - proposed end of data analyses from&#xD;
      fourth wave of the study June 2022.&#xD;
&#xD;
      Participant Duration: Each participant will be invited to take the online survey every&#xD;
      six-nine months for four data collection periods. Each survey will last 30-45 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">May 18, 2022</completion_date>
  <primary_completion_date type="Actual">May 18, 2022</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>Stress</measure>
    <time_frame>BASELINE, MONTH 6, MONTH 12, MONTH 18</time_frame>
    <description>We will examine how the COVID-19 pandemic impacts stress levels among individuals with sickle cell disease (SCD).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain episodes, and severity</measure>
    <time_frame>BASELINE, MONTH 6, MONTH 12, MONTH 18</time_frame>
    <description>We will examine the association between clinical severity of SCD and an individual s response to the COVID-19 pandemic.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Healthcare utilization (primary care, emergency department, telehealth other)</measure>
    <time_frame>BASELINE, MONTH 6, MONTH 12, MONTH 18</time_frame>
    <description>We will investigate the impact of the COVID-19 pandemic on healthcare utilization for SCD individuals.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depressive symptomology</measure>
    <time_frame>BASELINE, MONTH 6, MONTH 12, MONTH 18</time_frame>
    <description>This is an examination of questions relating to depression, which we will examine within our cohort.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>BASELINE, MONTH 6, MONTH 12, MONTH 18</time_frame>
    <description>We will examine how the COVID-19 pandemic impacts anxiety levels among individuals with SCD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Receptivity to future health recommendations and medical treatment(s).</measure>
    <time_frame>Baseline, month 6, month 12, month 18</time_frame>
    <description>We would like to explore how the attitudes about treatment and levels of trust will serve as mediating factors for the experiences of individuals with SCD during this pandemic.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Isolation</condition>
  <condition>Anxiety</condition>
  <condition>Health Care Utilization</condition>
  <condition>Sickle Cell Disease</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Sickle Cell Disease</arm_group_label>
    <description>Individuals with sickle cell disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Utilizing social media to reach across all scd populations in the united states.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        In order to be eligible to participate in this study, an individual must meet all of the&#xD;
        following criteria:&#xD;
&#xD;
          1. Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study&#xD;
&#xD;
          2. Adults, aged 18 years or older, of any race, sex, gender, ethnicity, and/or&#xD;
             nationality&#xD;
&#xD;
          3. Sickle Cell Disease, any genotype&#xD;
&#xD;
          4. Current Resident of the United States&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        An individual who meets any of the following criteria will be excluded from participation&#xD;
        in this study:&#xD;
&#xD;
          1. Minors less than 18 years of age&#xD;
&#xD;
          2. Adults with Sickle Cell Trait, Beta Thalassemia, Alpha Thalassemia or any blood&#xD;
             disorder other than Sickle Cell Disorder&#xD;
&#xD;
          3. Adults who lack access to the Internet&#xD;
&#xD;
          4. Live outside the United States (unless they are from the INSIGHTS Study)&#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>Vence L Bonham, J.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Human Genome Research Institute (NHGRI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Human Genome Research Institute (NHGRI)</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hussain FA, Njoku FU, Saraf SL, Molokie RE, Gordeuk VR, Han J. COVID-19 infection in patients with sickle cell disease. Br J Haematol. 2020 Jun;189(5):851-852. doi: 10.1111/bjh.16734. Epub 2020 May 8. No abstract available.</citation>
    <PMID>32314798</PMID>
  </reference>
  <verification_date>July 26, 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>July 27, 2023</last_update_submitted>
  <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mental Health</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Sickle Cell Pandemic Wellness</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Anemia, Sickle Cell</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/NCT04417673
org study id: 999920125
secondary id: 20-HG-N125
nct id: NCT04417673
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      Sickle cell disease (SCD) is a chronic illness. It affects about 100,000 people in the United
      States. People with SCD have red blood cells that are sickle-shaped and impaired in their
      function. This results in a lifetime of complications that affect every organ system. People
      with SCD also are at greater risk for respiratory infections and lung problems. Researchers
      want to study how this population s stress, anxiety, fear, pain, sleep, and health care use
      are being affected by the COVID-19 pandemic.

      Objective:

      To study the extent and impact of life changes induced by the COVID-19 pandemic on people
      living with SCD in the U.S.

      Eligibility:

      People age 18 and older with SCD who live in the U.S.

      Design:

      Participants will complete a survey online. The questions will focus on the following:

      Medical history

      Mental and physical health

      Demographics

      Stress

      Resilience

      Health care use

      COVID-19

      Beliefs about medical mistrust and participation in research.

      At the end of the survey, participants will be asked if they would like to take the survey
      again in the future. If they reply "yes," then they will be contacted by the study team in
      6-9 months to take the survey again. They may complete the survey again in 6-8 months, 12-15
      months, and 18-21 months.

      The survey should take less than 40 minutes to complete.

      Participants' data will be coded to protect their privacy. The coded data may be shared with
      other researchers.
Study Description:

      Longitudinal online survey of adults living with sickle cell disease (SCD) in the United
      States. The objective of the study is to examine the extent and impact of life changes
      induced by the COVID-19 pandemic on individuals living with SCD. It is our hypotheses that
      adults living with SCD will be adversely impacted by COVID-19 in terms of stress, anxiety,
      coping and sleep. Individuals living with SCD will have higher fear, isolation, anxiety and
      stress if they have higher clinical severity. In-person healthcare utilization for
      individuals with SCD will be reduced during the COVID-19 pandemic. Virtual healthcare
      utilization will increase for SCD individuals but satisfaction with healthcare quality will
      decrease.

      Objectives:

      Primary Objective: The primary objective of the study is to examine the extent and impact of
      life changes induced by the COVID-19 pandemic on individuals living with sickle cell disease
      (SCD). These objectives are: (1) To assess how the COVID-19 pandemic affects the
      psychological well-being of individuals living with SCD; (2) To examine the association
      between clinical severity of SCD and an individual s response to the COVID-19 pandemic; (3)
      To investigate whether news and other media consumption during the COVID-19 pandemic
      influence individual psychological well-being; (4) To determine the extent of COVID-19
      induced trauma in individuals living with SCD, and its effect on health behaviors and
      psychological well-being; (5) To investigate the impact of the COVID-19 pandemic on
      healthcare utilization for SCD individuals.

      Secondary Objectives: Our secondary objectives broadly examine the attitudes and viewpoints
      of individuals with SCD on issues of trust and the future of medical advancements for
      COVID-19 treatment(s). These will be examined in conjunction with the primary objectives and
      are: (1) To examine the role that medical and government mistrust may have on the experiences
      and behaviors of individuals with SCD during the pandemic; (2) To assess community attitudes
      towards clinical trials for COVID-19.

      Endpoints:

      The endpoints for the study are divided into psychosocial measures as well as physical
      measures and are: (1) Stress; (2) Anxiety; (3) Depressive symptomology; (4) Sleep; (5) Pain
      episodes and clinical severity; (6) Healthcare utilization (primary care, emergency

      department, telemedicine, other). The secondary endpoint is an examination of the receptivity
      of SCD individuals to future health recommendations and medical treatment(s).

      Study Population: Sample up to 1000 adults living with SCD in the United States, 18 years of
      age or older.

      Description of Sites/Facilities Enrolling Participants:

      Two cohorts will be recruited for this study: (1) Participants in the INSIGHTS study
      (NCT02156102) (2) Participants recruited by Sickle Cell 101 and/or from the NIH Study
      (NCT01633021), and/or from other advocacy groups or doctor s offices. Sickle Cell 101 (SC101)
      is a Silicon Valley-based non-profit organization that specializes in sickle cell education
      for the patients, caregivers, healthcare professionals, and other key stakeholders affected
      by sickle cell disease and trait globally.

      Study Duration: Proposed enrollment opening June 1, 2020 - proposed end of data analyses from
      fourth wave of the study June 2022.

      Participant Duration: Each participant will be invited to take the online survey every
      six-nine months for four data collection periods. Each survey will last 30-45 minutes.
observational model: Cohort
time perspective: Prospective
measure: Stress
time frame: BASELINE, MONTH 6, MONTH 12, MONTH 18
description: We will examine how the COVID-19 pandemic impacts stress levels among individuals with sickle cell disease (SCD).
measure: Pain episodes, and severity
time frame: BASELINE, MONTH 6, MONTH 12, MONTH 18
description: We will examine the association between clinical severity of SCD and an individual s response to the COVID-19 pandemic.
measure: Healthcare utilization (primary care, emergency department, telehealth other)
time frame: BASELINE, MONTH 6, MONTH 12, MONTH 18
description: We will investigate the impact of the COVID-19 pandemic on healthcare utilization for SCD individuals.
measure: Depressive symptomology
time frame: BASELINE, MONTH 6, MONTH 12, MONTH 18
description: This is an examination of questions relating to depression, which we will examine within our cohort.
measure: Anxiety
time frame: BASELINE, MONTH 6, MONTH 12, MONTH 18
description: We will examine how the COVID-19 pandemic impacts anxiety levels among individuals with SCD.
measure: Receptivity to future health recommendations and medical treatment(s).
time frame: Baseline, month 6, month 12, month 18
description: We would like to explore how the attitudes about treatment and levels of trust will serve as mediating factors for the experiences of individuals with SCD during this pandemic.
arm group label: Sickle Cell Disease
description: Individuals with sickle cell disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vence L Bonham, J.D.
role: Principal Investigator
affiliation: National Human Genome Research Institute (NHGRI)
facility: 
country: United States
citation: Hussain FA, Njoku FU, Saraf SL, Molokie RE, Gordeuk VR, Han J. COVID-19 infection in patients with sickle cell disease. Br J Haematol. 2020 Jun;189(5):851-852. doi: 10.1111/bjh.16734. Epub 2020 May 8. No abstract available.
PMID: 32314798
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Anemia, Sickle Cell