Living With Sickle Cell Disease in the COVID-19 Pandemic

NCT04417673 | Completed

• 2 other identifiers: 99992012520-HG-N125
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Health Care Utilization; Sickle Cell Disease; Isolation; Anxiety

Keywords

Mental Health; Quality of Life; Sickle Cell Pandemic Wellness; Natural History

Outcome Measures

Primary Outcomes (5)

• Stress

  We will examine how the COVID-19 pandemic impacts stress levels among individuals with sickle cell disease (SCD).

  BASELINE, MONTH 6, MONTH 12, MONTH 18

• Pain episodes, and severity

  We will examine the association between clinical severity of SCD and an individual s response to the COVID-19 pandemic.

  BASELINE, MONTH 6, MONTH 12, MONTH 18

• Healthcare utilization (primary care, emergency department, telehealth other)

  We will investigate the impact of the COVID-19 pandemic on healthcare utilization for SCD individuals.

  BASELINE, MONTH 6, MONTH 12, MONTH 18

• Depressive symptomology

  This is an examination of questions relating to depression, which we will examine within our cohort.

  BASELINE, MONTH 6, MONTH 12, MONTH 18

• Anxiety

  We will examine how the COVID-19 pandemic impacts anxiety levels among individuals with SCD.

  BASELINE, MONTH 6, MONTH 12, MONTH 18

Secondary Outcomes (1)

• Receptivity to future health recommendations and medical treatment(s).

  Baseline, month 6, month 12, month 18

Study Arms (1)

Sickle Cell Disease

Individuals with sickle cell disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Utilizing social media to reach across all scd populations in the united states.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Adults, aged 18 years or older, of any race, sex, gender, ethnicity, and/or nationality
• Sickle Cell Disease, any genotype
• Current Resident of the United States

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Minors less than 18 years of age
• Adults with Sickle Cell Trait, Beta Thalassemia, Alpha Thalassemia or any blood disorder other than Sickle Cell Disorder
• Adults who lack access to the Internet
• Live outside the United States (unless they are from the INSIGHTS Study)

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI): lead

Study Sites (1)

National Human Genome Research Institute (NHGRI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Patient Acceptance of Health Care; Anemia, Sickle Cell; Pain; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction

Study Officials

• Ashley J Buscetta, C.R.N.P.

  National Human Genome Research Institute (NHGRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 5, 2020
• Study Start: June 15, 2020
• Primary Completion: May 18, 2022
• Study Completion: May 18, 2022
• Last Updated: April 8, 2026

Record last verified: 2025-04-09

Locations

US (1)