Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke

NCT06615973 | Recruiting

• 2 other identifiers: 10001861001861-N
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Brain Disease; Vascular Diseases; Cerebrovascular Disorder

Keywords

Stroke; Social Determinants of Health; Cognition; cerebrovascular health; Magnetic Resonance Imaging (MRI); vascular health

Outcome Measures

Primary Outcomes (1)

• Post-stroke function as defined by NIH Stroke Scale (NIHSS)

  Will use linear regression models to assess association between core infarct volume and post stroke function (as defined by NIHSS) as modified by SDOH

  NIHSS and core infarct volume gathered at time of enrollment in Natural History of Stroke study, SDOH gathered at present

Secondary Outcomes (1)

• Present-day cognitive function

  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

Study Arms (1)

Patients

Participants who were enrolled in Natural History Study in past 6 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 28122885 BACKGROUND

• 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.

  PMID: 17258669 BACKGROUND

• 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.

  PMID: 30076114 BACKGROUND

• 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.

  PMID: 23150656 BACKGROUND

• 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.

  PMID: 37125534 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Stroke; Brain Diseases; Vascular Diseases; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases

Study Officials

• Rebecca F Gottesman, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca F Gottesman, M.D.

CONTACT

(301) 435-9321; rebecca.gottesman@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04-27

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: De-identifiable data will be made available as soon as possible or at the time of associated publication, whichever comes first.@@@@@@
• Access Criteria: Requests for data access will need to adhere to the standard processes per each repository. These repositories allow for querying and access to shared datasets.

Locations

US (1)