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

Not Applicable

Completed

• Conditions: Stroke Ischemic; Minority Health
• Interventions: Behavioral: Community-based Intervention under Nurse Guidance after Stroke

• Registration Number: NCT02982278
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-01
• Study First Posted: 2016-12-05
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Community-based Intervention under Nurse Guidance after Stroke	Control group will receive usual care. Base line visit and follow up at 3, 6, and 12 months post stroke enrollment.
CINGS Intervention	Community-based Intervention under Nurse Guidance after Stroke	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.

Primary Outcome Measures

Name	Time	Method
Stroke Specific Quality of Life Scale	3, 6, 12 months	Quality of Life
NIH Stroke Scale	0, 3, months	Stroke Severity
Stroke Impact Scale	3, 6, 12 months	Stroke recovery

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9	3, 6 12 months	Depression
Medical Outcomes Study Social Support Scale	3, 6, 12 months	Social Support

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States