A Longitudinal Survey Study on Living With Sickle Cell Disease in the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Pain episodes, and severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •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
排除标准
- •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)
研究组 & 干预措施
Sickle Cell Disease
Individuals with sickle cell disease
结局指标
主要结局
Pain episodes, and severity
时间窗: 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)
时间窗: BASELINE, MONTH 6, MONTH 12, MONTH 18
We will investigate the impact of the COVID-19 pandemic on healthcare utilization for SCD individuals.
Stress
时间窗: 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).
Depressive symptomology
时间窗: BASELINE, MONTH 6, MONTH 12, MONTH 18
This is an examination of questions relating to depression, which we will examine within our cohort.
Anxiety
时间窗: BASELINE, MONTH 6, MONTH 12, MONTH 18
We will examine how the COVID-19 pandemic impacts anxiety levels among individuals with SCD.
次要结局
- Receptivity to future health recommendations and medical treatment(s).(Baseline, month 6, month 12, month 18)