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)
National Human Genome Research Institute (NHGRI)
Bethesda, Maryland, United States
Vence L Bonham, J.D., Principal Investigator
National Human Genome Research Institute (NHGRI)