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

Wide Spectrum Investigation of Stroke Outcome Disparities on Multiple Levels (WISSDOM): Community-based Intervention Under Nurse Guidance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02982278
Acronym
CINGS
Enrollment
87
Registered
2016-12-05
Start date
2015-10-31
Completion date
2020-06-30
Last updated
2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minority Health, Stroke Ischemic

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.

Interventions

BEHAVIORALCommunity-based Intervention under Nurse Guidance after Stroke

CINGS is a 12-week nurse coordinated, Community Health Worker intervention structure. Intervention home visits will be conducted by the CHW and will include home-based training in self-care and self-management strategies alongside strategies to address risk of negative stroke outcomes that will be determined once these risk factors are identified and community-engaged approaches to their resolution derived. CHW efforts will be guided via televideo interactions with nurse coordinator. During home-visits, self-reported assessments will be collected via RedCap as well as assessments collected by the CHW and research nurse (weight, blood pressure, medication adherence). After baseline, participants randomized to the intervention group will have home visits, once a week for the first month, and biweekly for the other two months, conducted by the CHW. Additionally, there will be post-intervention follow-up assessments at 3, 6, and 12-month time intervals.

Sponsors

American Heart Association
CollaboratorOTHER
Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stroke Specific Quality of Life Scale3, 6, 12 monthsQuality of Life
Stroke Impact Scale3, 6, 12 monthsStroke recovery
NIH Stroke Scale0, 3, monthsStroke Severity

Secondary

MeasureTime frameDescription
Medical Outcomes Study Social Support Scale3, 6, 12 monthsSocial Support
Patient Health Questionnaire-93, 6 12 monthsDepression

Other

MeasureTime frameDescription
Stroke Self-Efficacy Scale3, 6, 12Self-efficacy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026