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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04417673|
Recruitment Status : Not yet recruiting
First Posted : June 5, 2020
Last Update Posted : April 21, 2021
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:
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|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||A Longitudinal Survey Study on Living With Sickle Cell Disease in the COVID-19 Pandemic|
|Estimated Study Start Date :||April 26, 2021|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2024|
Sickle Cell Disease
Individuals with sickle cell disease
- Stress [ Time Frame: Baseline, month 6, month 12, month 18 ]We will examine how theo COVID-19 pandemic impacts stress levels among individuals with sickle cell disease (SCD).
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Vence L Bonham, J.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Human Genome Research Institute (NHGRI)|
|Bethesda, Maryland, United States, 20892|
|Contact: Vence Bonham, J.D. 301-594-3973 email@example.com|
|Principal Investigator:||Vence L Bonham, J.D.||National Human Genome Research Institute (NHGRI)|