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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

450 Participants
are grouped into 1 trial group
Group A: Patients

Trial outcomes

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

Time frame
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

Will use linear regression models to assess association between core infarct volume and present-day cognition as modified by SDOH

Time frame
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

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