Clinical trial NCT02982278: Wide Spectrum Investigation of Stroke Outcome Disparities on Multiple Levels (WISSDOM)
Official title: Wide Spectrum Investigation of Stroke Outcome Disparities on Multiple Levels (WISSDOM): Community-based Intervention Under Nurse Guidance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Ischemic
Minority Health
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2016-12-05
Enrollment: 87
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stroke Specific Quality of Life Scale
timeFrame: 3, 6, 12 months
measure: Stroke Impact Scale
timeFrame: 3, 6, 12 months
measure: NIH Stroke Scale
timeFrame: 0, 3, months
Secondary outcomes:
measure: Medical Outcomes Study Social Support Scale
timeFrame: 3, 6, 12 months
measure: Patient Health Questionnaire-9
timeFrame: 3, 6 12 months
Other outcomes:
measure: Stroke Self-Efficacy Scale
timeFrame: 3, 6, 12
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Gayenell Magwood, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buie JNJ, Zhao Y, Burns S, Magwood G, Adams R, Sims-Robinson C, Lackland DT; WISSDOM Research Center Study Group. Racial Disparities in Stroke Recovery Persistence in the Post-Acute Stroke Recovery Phase: Evidence from the Health and Retirement Study. Ethn Dis. 2020 Apr 23;30(2):339-348. doi: 10.18865/ed.30.2.339. eCollection 2020 Spring.