Wide Spectrum Investigation of Stroke Outcome Disparities on Multiple Levels (WISSDOM) (CINGS)

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Stroke Ischemic; Minority Health

Treatments: Behavioral: Community-based Intervention under Nurse Guidance after Stroke

Study type: Interventional

Funder types: Other

Identifiers

NCT02982278

PRO 46339

Details and patient eligibility

About

This research project will evaluate the relationship between cardiovascular risk factors, degrees of physical and mental activity prior to the stroke, brain tissue integrity, post-stroke community participation and neurological recovery after the stroke. Investigators will recruit and study healthy and post stroke participants, gaining insight into the possible mechanisms that explain why the adverse risk profile, which is more commonly present in African-Americans than non-Hispanic Whites in the stroke belt, is translated into a less favorable recovery post stroke.

Full description

Stroke is a common cause of disability, but not all subjects who survive a stroke are left with debilitating sequelae. The human brain is able to self-repair and adapt after injury through neuroplasticity, which is crucial for stroke recovery. At present, recovery cannot be completely predicted from clinical stroke variables. A promising theory suggests that the health status of the stroke host is as important as stroke severity for recovery. Within the neurological system, health is reflected by the integrity of the brain tissue and its neuronal environment, which provide the neuroplastic potential that is necessary for recovery. The potential for neuroplasticity is likely variable across individuals and possibly accounts for some of the differences in outcome that cannot be explained by other clinical factors.

A better understanding of the relationship between stroke outcomes, host brain tissue integrity and recovery environment would have immense potential to address stroke related disabilities. The investigators are experts in research involving brain tissue integrity using neuroimaging and recovery environment using community based participation approaches involving nurse-guided community health workers (CHWs).

This research project will evaluate the relationship between cardiovascular risk factors, degrees of physical and mental activity prior to the stroke, brain tissue integrity, post-stroke community participation and neurological recovery after the stroke. The investigators will recruit and study a biracial cohort, gaining insight into the possible mechanisms that explain why the adverse risk profile, which is more commonly present in African-Americans than non-Hispanic Whites in the stroke belt, is translated into a less favorable recovery post stroke. If a better understanding of the underlying reasons for this observation can be defined, an important first step toward eliminating this disparity can be achieved.

Enrollment: 87 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 40-75 years
• prestroke mRS score >2
• African American or White
• Reside in Berkeley, Charleston, Dorchester, Colleton or Georgetown Counties
• Ischemic stroke involving only one hemisphere
• Fugl Meyer score >16 at baseline or Aphasia Quotient in Western Aphasia Battery <93
• no contraindications to research MRI

Exclusion criteria

• Primary or secondary intracerebral hematoma, or subarachnoid hemorrhage, or subdural/ epidural hematoma; Prisoner; diagnoses of substance addiction (alcohol or illicit drugs)
• Bihemispheric acute ischemic strokes;
• Other concomitant neurological disorders, such as brain tumor, abscess or spinal cord disease affecting language or limb motor function;
• Documented history of dementia prior to index event;
• Patient suffered one or more recurrent stroke during the 12-month follow up period.
• Terminal illness with life expectancy ≤ 1 year
• Currently pregnant
• Brain stem strokes

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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87 participants in 2 patient groups

CINGS Intervention

Experimental group

Description:

CINGS is a 12-week nurse coordinated, Community Health Worker (CHW) intervention structure. Registered Nurse (RN) developed After hospital care plan with home visits sessions will be conducted by the CHW and intermittent televideo RN interactions. After baseline assessment, participants randomized to the intervention group will have home visits, once a week for the first month, and biweekly during months two and three. follow up assessments at 3, 6, and 12-month intervals.

Treatment:

Behavioral: Community-based Intervention under Nurse Guidance after Stroke

Control

Experimental group

Description:

Control group will receive usual care. Base line visit and follow up at 3, 6, and 12 months post stroke enrollment.

Treatment:

Behavioral: Community-based Intervention under Nurse Guidance after Stroke