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

Tracking Information
First Submitted Date June 4, 2020
First Posted Date June 5, 2020
Last Update Posted Date July 7, 2022
Actual Study Start Date June 15, 2020
Actual Primary Completion Date May 18, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 19, 2021)
  • 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.
Original Primary Outcome Measures
 (submitted: June 4, 2020)
  • 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.
Change History
Current Secondary Outcome Measures
 (submitted: January 7, 2021)		 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.
Original Secondary Outcome Measures
 (submitted: June 4, 2020)		 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Living With Sickle Cell Disease in the COVID-19 Pandemic
Official Title A Longitudinal Survey Study on Living With Sickle Cell Disease in the COVID-19 Pandemic
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Utilizing social media to reach across all scd populations in the united states.
Condition
  • Isolation
  • Anxiety
  • Health Care Utilization
  • Sickle Cell Disease
  • Pain
Intervention Not Provided
Study Groups/Cohorts Sickle Cell Disease
Individuals with sickle cell disease
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 19, 2022)		 500
Original Estimated Enrollment
 (submitted: June 4, 2020)		 700
Actual Study Completion Date May 18, 2022
Actual Primary Completion Date May 18, 2022   (Final data collection date for primary outcome measure)
Eligibility 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 (unless they are from the INSIGHTS Study)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04417673
Other Study ID Numbers 999920125
20-HG-N125
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
Original Responsible Party Same as current
Current Study Sponsor National Human Genome Research Institute (NHGRI)
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Vence L Bonham, J.D. National Human Genome Research Institute (NHGRI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date May 18, 2022