Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615973
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Screening for Social Determinants of Health SDOH and Cognitive Function in Individuals With History of Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Screening for Social Determinants of Health SDOH and Cognitive Function in Individuals With History of Stroke
Status:
RECRUITING
Status Verified Date:
2024-09-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Stroke is the fifth leading cause of death in the United States It is also a leading cause of disability More than 70 of people who survive strokes have mental impairment or dementia Medical factors such as the severity of the stroke affect whether a person will have mental impairment afterward But social factors such as education and ethnicity seem to play a role as well Researchers want to learn more about how social and lifestyle factors affect a person s chances of maintaining mental functions after a stroke
Objective
To better understand how social and lifestyle factors affect the risk of mental impairment after a stroke
Eligibility
People aged 18 years and older who had a stroke and a brain scan while they were enrolled in NIH Study 01N0007 Natural History of Stroke Study
Design
Participants will have 1 study visit by telephone The call will last about 45 minutes Participants will talk about their health since their stroke They will answer questions about themselves Topics will include
Their race
Education
Ethnicity
Employment
Marital status
Residence address
Recent health history
Medical insurance
They will have tests of their memory attention and language skills They will repeat numbers and words forward and backward
Researchers will look at the data and imaging scans collected during participant s enrollment in NIH Study 01N0007 This data will include
The hospital that first saw the participant at the time of their stroke
The type of imaging that was first used then
The primary diagnosis at admission
Other medical details
Stroke is the fifth leading cause of death in the United States It is also a leading cause of disability More than 70 of people who survive strokes have mental impairment or dementia Medical factors such as the severity of the stroke affect whether a person will have mental impairment afterward But social factors such as education and ethnicity seem to play a role as well Researchers want to learn more about how social and lifestyle factors affect a person s chances of maintaining mental functions after a stroke
Objective
To better understand how social and lifestyle factors affect the risk of mental impairment after a stroke
Eligibility
People aged 18 years and older who had a stroke and a brain scan while they were enrolled in NIH Study 01N0007 Natural History of Stroke Study
Design
Participants will have 1 study visit by telephone The call will last about 45 minutes Participants will talk about their health since their stroke They will answer questions about themselves Topics will include
Their race
Education
Ethnicity
Employment
Marital status
Residence address
Recent health history
Medical insurance
They will have tests of their memory attention and language skills They will repeat numbers and words forward and backward
Researchers will look at the data and imaging scans collected during participant s enrollment in NIH Study 01N0007 This data will include
The hospital that first saw the participant at the time of their stroke
The type of imaging that was first used then
The primary diagnosis at admission
Other medical details
Detailed Description:
Study Description
Clinical health outcomes and the likelihood of post stroke cognitive impairment and dementia PSCID can greatly vary following stroke incidence Thus developing a better understanding of what characteristics might provide resilience and enrich post-stroke recovery is of utmost importance The NINDS Natural History of Stroke study 01N0007 was designed with the intention to generate natural history data of participants with or at-risk for acute stroke transient ischemic attack TIA and other disturbances of cerebrovascular circulation Through use of participants enrolled in the Natural History of Stroke study within the past six years we aim to characterize social determinants of health SDOH and present-day cognitive function in this cohort Following the collection of these data we will examine how the core volume of acute supratentorial infarcts relates to post-stroke function as measured by the NIHSS and how this association is modified based upon SDOH features and independent of treatment
Objectives
To characterize SDOH and assess if such characteristics modify the relationship between MRI core infarct volume and post-stroke function ie NIHSS at baseline andor discharge Resilience will thus be assessed by evaluating how specified SDOH modify the correlation between MRI core infarct volume and NIHSS
To assess present cognitive function and assess if SDOH modify the relationship between MRI core infarct volume and present-day cognition Resilience will thus be assessed by evaluating how SDOH modify the correlation between infarct volume and present-day cognition
To assess if SDOH modify the relationship between poststroke function ie NIHSS at baseline andor discharge with present-day cognition Resilience will thus be assessed by evaluating how SDOH modify the correlation between NIHSS and present-day cognition
Endpoints
The primary purpose of this study is to assess SDOH and cognitive function in participants who have had a stroke in the past six years To this end the primary study outcomes will be post-stroke function as defined by NIHSS and present-day cognitive function
Primary Endpoint Association between MRI core infarct volume and post-stroke function ie NIHSS as modified by SDOH
Secondary Endpoints Association between MRI core infarct volume and present-day cognitive function as modified by SDOH
Exploratory Endpoint Association between post-stroke function ie NIHSS and present-day cognitive function as modified by SDOH
Clinical health outcomes and the likelihood of post stroke cognitive impairment and dementia PSCID can greatly vary following stroke incidence Thus developing a better understanding of what characteristics might provide resilience and enrich post-stroke recovery is of utmost importance The NINDS Natural History of Stroke study 01N0007 was designed with the intention to generate natural history data of participants with or at-risk for acute stroke transient ischemic attack TIA and other disturbances of cerebrovascular circulation Through use of participants enrolled in the Natural History of Stroke study within the past six years we aim to characterize social determinants of health SDOH and present-day cognitive function in this cohort Following the collection of these data we will examine how the core volume of acute supratentorial infarcts relates to post-stroke function as measured by the NIHSS and how this association is modified based upon SDOH features and independent of treatment
Objectives
To characterize SDOH and assess if such characteristics modify the relationship between MRI core infarct volume and post-stroke function ie NIHSS at baseline andor discharge Resilience will thus be assessed by evaluating how specified SDOH modify the correlation between MRI core infarct volume and NIHSS
To assess present cognitive function and assess if SDOH modify the relationship between MRI core infarct volume and present-day cognition Resilience will thus be assessed by evaluating how SDOH modify the correlation between infarct volume and present-day cognition
To assess if SDOH modify the relationship between poststroke function ie NIHSS at baseline andor discharge with present-day cognition Resilience will thus be assessed by evaluating how SDOH modify the correlation between NIHSS and present-day cognition
Endpoints
The primary purpose of this study is to assess SDOH and cognitive function in participants who have had a stroke in the past six years To this end the primary study outcomes will be post-stroke function as defined by NIHSS and present-day cognitive function
Primary Endpoint Association between MRI core infarct volume and post-stroke function ie NIHSS as modified by SDOH
Secondary Endpoints Association between MRI core infarct volume and present-day cognitive function as modified by SDOH
Exploratory Endpoint Association between post-stroke function ie NIHSS and present-day cognitive function as modified by SDOH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None