Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05369611
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-05
First Post:
2022-05-07
Brief Title:
COVID-19 Experiences in the SELF Cohort
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
COVID-19 Experiences in the SELF Cohort A Cross-Sectional Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
COVID-19 affected African Americans more than Whites African Americans especially women have had higher rates of COVID-19 infections compared to Whites They are also more likely to go to the hospital or die of this disease Many researchers who looked into these issues lacked background data on the people they studied SELF is a 10-year study of fibroids in African American women aged 23-35 Researchers already have a lot of data on these women Asking how COVID-19 affected them can add context other studies lack
Objective
To describe the impact of the COVID-19 pandemic on young African American women and their families
Eligibility
Participants must be enrolled in SELF Study of Environment Lifestyle and Fibroids
Design
Researchers will invite all women enrolled in SELF to participate in this natural history study
Participants will complete one questionnaire They will answer the questions online They may also choose to get a paper copy sent by mail The survey will take no more than 15-20 minutes
All questions will relate to COVID-19 Participants will be asked if they had COVID-19 They will be asked if family friends or members of their community did They will answer questions about their vaccine status and access to health care services
Participants will also answer questions about how the pandemic affected their lives They will be asked about their job and if finding childcare was a challenge They will be asked about money problems and how they coped They will be asked about sleep problems and emotional distress
Participants will get a 30 gift card after they finish the survey
COVID-19 affected African Americans more than Whites African Americans especially women have had higher rates of COVID-19 infections compared to Whites They are also more likely to go to the hospital or die of this disease Many researchers who looked into these issues lacked background data on the people they studied SELF is a 10-year study of fibroids in African American women aged 23-35 Researchers already have a lot of data on these women Asking how COVID-19 affected them can add context other studies lack
Objective
To describe the impact of the COVID-19 pandemic on young African American women and their families
Eligibility
Participants must be enrolled in SELF Study of Environment Lifestyle and Fibroids
Design
Researchers will invite all women enrolled in SELF to participate in this natural history study
Participants will complete one questionnaire They will answer the questions online They may also choose to get a paper copy sent by mail The survey will take no more than 15-20 minutes
All questions will relate to COVID-19 Participants will be asked if they had COVID-19 They will be asked if family friends or members of their community did They will answer questions about their vaccine status and access to health care services
Participants will also answer questions about how the pandemic affected their lives They will be asked about their job and if finding childcare was a challenge They will be asked about money problems and how they coped They will be asked about sleep problems and emotional distress
Participants will get a 30 gift card after they finish the survey
Detailed Description:
Study Description
This cross-sectional study will be an add-on to the Study of Environment Lifestyle and Fibroids SELF Protocol Number 10-E-N044 SELF is a prospective cohort study of fibroid development From November 2010 to December 2012 the study enrolled a volunteer sample recruited from Detroit MI and surrounding areas of approximately 1700 African-American women ages 23-35 without a diagnosis of fibroids SELF has been a rich information source regarding the health of young African-American women
This current COVID-19 study will focus on collecting information regarding SELF participant s experiences throughout the COVID-19 pandemic through a short one-time online questionnaire The questionnaire will contain questions on a range of topics related to the COVID-19 pandemic to include 1 pandemic experiences in the following domains COVID-19 illness of participant including LONG-COVID participant s family and friends participants social community 2 vaccination status 3 access to health care 4 employment vulnerabilities and employment loss 5 challenges with caring for children 6 financial hardship coping strategies 7 sleep problems and 8 psychosocial stressors The questionnaire will also ask questions about COVID-19-related symptoms vaccination and hospitalizations experienced by the participants andor members of her household and community
Objectives
Primary Objective
To describe the impact of the COVID-19 pandemic on reproductive-aged African American women and their families We have three goals
First these basic data will be summarized in a report that will be sent back to the participants Like our newsletters this will serve as a cohort maintenance activity keeping our participants interested and engaged in the study
Secondly SELF collaborators are continuing to follow the participants the 4th follow-up is in progress and a 5th follow-up is being planned so these data will allow us to consider the impact of COVID-19 in future analyses Additional studies with this cohort could also be undertaken in the future Depending upon the exposure outcome being investigated in the data from those additional follow ups an overall measure of impact may be important or the impact on specific domains may be of most interest
Thirdly we also view this study as an opportunity to document the impact of the COVID-19 pandemic a once in a century event in a well characterized group of reproductive-aged African-American women whose health and well-being have been followed for nearly a decade now This is an understudied group and documenting their response to COVID will serve as one of several case-studies of specific subpopulations that are likely to emerge after the pandemic The goal is to document the range of adverse impacts experienced and the factors eg low income limited educational attainment pre-pandemic health conditions neighborhood factors that might mitigate or exacerbate those adverse impacts for this understudied demographic group
Endpoints
Primary Endpoint Descriptive data on impact of the COVID-19 pandemic on reproductive-aged African American women and their families
This cross-sectional study will be an add-on to the Study of Environment Lifestyle and Fibroids SELF Protocol Number 10-E-N044 SELF is a prospective cohort study of fibroid development From November 2010 to December 2012 the study enrolled a volunteer sample recruited from Detroit MI and surrounding areas of approximately 1700 African-American women ages 23-35 without a diagnosis of fibroids SELF has been a rich information source regarding the health of young African-American women
This current COVID-19 study will focus on collecting information regarding SELF participant s experiences throughout the COVID-19 pandemic through a short one-time online questionnaire The questionnaire will contain questions on a range of topics related to the COVID-19 pandemic to include 1 pandemic experiences in the following domains COVID-19 illness of participant including LONG-COVID participant s family and friends participants social community 2 vaccination status 3 access to health care 4 employment vulnerabilities and employment loss 5 challenges with caring for children 6 financial hardship coping strategies 7 sleep problems and 8 psychosocial stressors The questionnaire will also ask questions about COVID-19-related symptoms vaccination and hospitalizations experienced by the participants andor members of her household and community
Objectives
Primary Objective
To describe the impact of the COVID-19 pandemic on reproductive-aged African American women and their families We have three goals
First these basic data will be summarized in a report that will be sent back to the participants Like our newsletters this will serve as a cohort maintenance activity keeping our participants interested and engaged in the study
Secondly SELF collaborators are continuing to follow the participants the 4th follow-up is in progress and a 5th follow-up is being planned so these data will allow us to consider the impact of COVID-19 in future analyses Additional studies with this cohort could also be undertaken in the future Depending upon the exposure outcome being investigated in the data from those additional follow ups an overall measure of impact may be important or the impact on specific domains may be of most interest
Thirdly we also view this study as an opportunity to document the impact of the COVID-19 pandemic a once in a century event in a well characterized group of reproductive-aged African-American women whose health and well-being have been followed for nearly a decade now This is an understudied group and documenting their response to COVID will serve as one of several case-studies of specific subpopulations that are likely to emerge after the pandemic The goal is to document the range of adverse impacts experienced and the factors eg low income limited educational attainment pre-pandemic health conditions neighborhood factors that might mitigate or exacerbate those adverse impacts for this understudied demographic group
Endpoints
Primary Endpoint Descriptive data on impact of the COVID-19 pandemic on reproductive-aged African American women and their families
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000811-E | None | None | None |