Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )

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 months to take the survey again. They may complete the survey again in 6 months, 12 months, and 18 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

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Longitudinal Survey Study on Living With Sickle Cell Disease in the COVID-19 Pandemic
Estimated Study Start Date : July 7, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort
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 theo COVID-19 pandemic impacts stress levels among individuals with sickle cell disease (SCD).

  2. 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.

  3. 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.

  4. 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.

  5. 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.


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.


Layout table for eligibility information
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.
Criteria
  • 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

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


Contacts
Layout table for location contacts
Contact: Vence L Bonham, J.D. (301) 594-3973 bonhamv@nhgri.nih.gov

Locations
Layout table for location information
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Contact: Nathan Jones    608-890-4724    nrjones@ssc.wisc.edu   
Sponsors and Collaborators
National Human Genome Research Institute (NHGRI)
Investigators
Layout table for investigator information
Principal Investigator: Vence L Bonham, J.D. National Human Genome Research Institute (NHGRI)
Publications:
Layout table for additonal information
Responsible Party: National Human Genome Research Institute (NHGRI)
ClinicalTrials.gov Identifier: NCT04417673    
Other Study ID Numbers: 999920125
20-HG-N125
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2, 2020
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn