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Living With Sickle Cell Disease in the COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04417673
Recruitment Status : Completed
First Posted : June 5, 2020
Last Update Posted : July 7, 2022
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )

Brief Summary:


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.


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


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


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

Medical history

Mental and physical health




Health care use


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.

Condition or disease
Isolation Anxiety Health Care Utilization Sickle Cell Disease Pain

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Longitudinal Survey Study on Living With Sickle Cell Disease in the COVID-19 Pandemic
Actual Study Start Date : June 15, 2020
Actual Primary Completion Date : May 18, 2022
Actual Study Completion Date : May 18, 2022

Sickle Cell Disease
Individuals with sickle cell disease

Primary Outcome Measures :
  1. Stress [ Time Frame: BASELINE, MONTH 6, MONTH 12, MONTH 18 ]
    We will examine how the COVID-19 pandemic impacts stress levels among individuals with sickle cell disease (SCD).

  2. Pain episodes, and severity [ Time Frame: BASELINE, MONTH 6, MONTH 12, MONTH 18 ]
    We will examine the association between clinical severity of SCD and an individual s response to the COVID-19 pandemic.

  3. Healthcare utilization (primary care, emergency department, telehealth other) [ Time Frame: BASELINE, MONTH 6, MONTH 12, MONTH 18 ]
    We will investigate the impact of the COVID-19 pandemic on healthcare utilization for SCD individuals.

  4. Depressive symptomology [ Time Frame: BASELINE, MONTH 6, MONTH 12, MONTH 18 ]
    This is an examination of questions relating to depression, which we will examine within our cohort.

  5. Anxiety [ Time Frame: BASELINE, MONTH 6, MONTH 12, MONTH 18 ]
    We will examine how the COVID-19 pandemic impacts anxiety levels among individuals with SCD.

Secondary Outcome Measures :
  1. Receptivity to future health recommendations and medical treatment(s). [ Time Frame: Baseline, month 6, month 12, month 18 ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Utilizing social media to reach across all scd populations in the united states.

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


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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417673

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United States, Maryland
National Human Genome Research Institute (NHGRI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Human Genome Research Institute (NHGRI)
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Principal Investigator: Vence L Bonham, J.D. National Human Genome Research Institute (NHGRI)
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Responsible Party: National Human Genome Research Institute (NHGRI)
ClinicalTrials.gov Identifier: NCT04417673    
Other Study ID Numbers: 999920125
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: May 18, 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) ):
Mental Health
Quality of Life
Sickle Cell Pandemic Wellness
Natural History
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Pneumonia, Viral
Respiratory Tract Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases