Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke
NCT ID: NCT06615973
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2025-12-30
2026-02-01
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients
Participants who were enrolled in Natural History Study in past 6 years
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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
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
18 Years
99 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Responsible Party
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Principal Investigators
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Rebecca F Gottesman, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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NIH Clinical Center Office of Patient Recruitment (OPR)
Role: primary
References
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Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
Chalela JA, Kidwell CS, Nentwich LM, Luby M, Butman JA, Demchuk AM, Hill MD, Patronas N, Latour L, Warach S. Magnetic resonance imaging and computed tomography in emergency assessment of patients with suspected acute stroke: a prospective comparison. Lancet. 2007 Jan 27;369(9558):293-8. doi: 10.1016/S0140-6736(07)60151-2.
Clark DG, Boan AD, Sims-Robinson C, Adams RJ, Amella EJ, Benitez A, Lackland DT, Ovbiagele B. Differential Impact of Index Stroke on Dementia Risk in African-Americans Compared to Whites. J Stroke Cerebrovasc Dis. 2018 Oct;27(10):2725-2730. doi: 10.1016/j.jstrokecerebrovasdis.2018.05.048. Epub 2018 Aug 1.
Douiri A, Rudd AG, Wolfe CD. Prevalence of poststroke cognitive impairment: South London Stroke Register 1995-2010. Stroke. 2013 Jan;44(1):138-45. doi: 10.1161/STROKEAHA.112.670844. Epub 2012 Nov 13.
El Husseini N, Katzan IL, Rost NS, Blake ML, Byun E, Pendlebury ST, Aparicio HJ, Marquine MJ, Gottesman RF, Smith EE; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; Council on Hypertension; and Council on Lifestyle and Cardiometabolic Health. Cognitive Impairment After Ischemic and Hemorrhagic Stroke: A Scientific Statement From the American Heart Association/American Stroke Association. Stroke. 2023 Jun;54(6):e272-e291. doi: 10.1161/STR.0000000000000430. Epub 2023 May 1.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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001861-N
Identifier Type: -
Identifier Source: secondary_id
10001861
Identifier Type: -
Identifier Source: org_study_id