Clinical trial NCT06615973: Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke
Official title: Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Brain Disease
Vascular Diseases
Cerebrovascular Disorder
Keywords: Stroke
Social Determinants of Health
Cognition
cerebrovascular health
Magnetic Resonance Imaging (MRI)
vascular health
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2024-09-27
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants that were previously enrolled (and had a MRI) within the past 6 years in the NINDS Stroke Branch Natural History study will be recruited for enrollment in the present study. Estimated to be 450 participants (18 and older). Study will consist of one phone call and during the phone call, population will be assessed.

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.

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 (i.e., NIHSS) at baseline and/or 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 (i.e. NIHSS) at baseline and/or 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 (i.e. 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 (i.e. NIHSS) and present-day cognitive function as modified by SDOH.

Eligibility criteria: * 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 or older.
* Previous participant in the Natural History of Stroke with an interpretable baseline MRI scan, NIHSS measured at baseline or discharge, and admission diagnosis of ischemic stroke.
* Fluent in English or Spanish

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this

study:

* Modified Rankin Scale (mRS) = 6 at any follow-up (usually up to 90 days) in the Natural History of Stroke study (mRS = 6 indicates the participant is dead).
* Is pregnant per self-report

Primary outcomes:
measure: Post-stroke function as defined by NIH Stroke Scale (NIHSS)
timeFrame: NIHSS and core infarct volume gathered at time of enrollment in Natural History of Stroke study, SDOH gathered at present
Secondary outcomes:
measure: Present-day cognitive function
timeFrame: SDOH and present-day cognitive function gathered over phone (present "visit"), other data (including core infarct volume) gathered at time of Natural History of Stroke enrollment
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Neurological Disorders and Stroke (NINDS)
name: Rebecca F Gottesman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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