IsolationNCT04417673
Living With Sickle Cell Disease in the COVID-19 Pandemic
An observational study of Isolation and Anxiety, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Isolation, Anxiety, Health Care Utilization
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 18 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Utilizing social media to reach across all scd populations in the united states.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Human Genome Research Institute (NHGRI)
Bethesda, Maryland, 20892
About this study
Official title: A Longitudinal Survey Study on 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Isolation, Anxiety, Health Care Utilization, Sickle Cell Disease, Pain
- Keywords
- Mental Health, Quality of Life, Sickle Cell Pandemic Wellness, Natural History
- Medical subject headings
- Anxiety Disorders, Patient Acceptance of Health Care, Anemia, Sickle Cell, Pain, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sickle Cell Disease | Individuals with sickle cell disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
We will examine how the COVID-19 pandemic impacts stress levels among individuals with sickle cell disease (SCD).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: BASELINE, MONTH 6, MONTH 12, MONTH 18
Anxiety
We will examine how the COVID-19 pandemic impacts anxiety levels among individuals with SCD.
Measured: BASELINE, MONTH 6, MONTH 12, MONTH 18
Secondary outcomes (1)
Receptivity to future health recommendations and medical treatment(s).
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.
Measured: Baseline, month 6, month 12, month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start15 Jun 2020
- Primary completion18 May 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IsolationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ashley J Buscetta, C.R.N.P., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417673
- Sponsor's protocol ID
- 999920125
- Other IDs
- 20-HG-N125
- Status last verified
- 8 Jun 2026
- First submitted
- 4 Jun 2020
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32314798
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Survey Study on Living With Sickle Cell Disease in the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04417673
- Acronym / sponsor ID
- 999920125
- Conditions
- Isolation, Anxiety, Health Care Utilization, Sickle Cell Disease, Pain
- Keywords
- Mental Health, Quality of Life, Sickle Cell Pandemic Wellness, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sickle Cell Disease | – | –Individuals with sickle cell disease |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Utilizing social media to reach across all scd populations in the united states.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
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.
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.
1 secondary outcome
Receptivity to future health recommendations and medical treatment(s).
Time frame: Baseline, month 6, month 12, month 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 32314798Hussain 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley J Buscetta, C.R.N.P. principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Isolation and Anxiety, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: BASELINE, MONTH 6, MONTH 12, MONTH 18). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04417673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.