Living With Sickle Cell Disease in the COVID-19 Pandemic
Living With Sickle Cell Disease in the COVID-19 Pandemic
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.
-  INCLUSION CRITERIA:

 In order to be eligible to participate in this study, an individual must meet all of the
 following criteria:

 1. Stated willingness to comply with all study procedures and availability for the
 duration of the study

 2. Adults, aged 18 years or older, of any race, sex, gender, ethnicity, and/or
 nationality

 3. Sickle Cell Disease, any genotype

 4. Current Resident of the United States

 EXCLUSION CRITERIA:

 An individual who meets any of the following criteria will be excluded from participation
 in this study:

 1. Minors less than 18 years of age

 2. Adults with Sickle Cell Trait, Beta Thalassemia, Alpha Thalassemia or any blood
 disorder other than Sickle Cell Disorder

 3. Adults who lack access to the Internet

 4. Live outside the United States (unless they are from the INSIGHTS Study)