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

Minority Health Clinical Trial

— CINGS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982278
• Other study ID #: PRO 46339
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: June 30, 2020

Study information

• Verified date: February 2021
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Minority Health
• Stroke
• Stroke Ischemic

Intervention

Behavioral:
• Community-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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stroke Self-Efficacy Scale	Self-efficacy	3, 6, 12
Primary	Stroke Specific Quality of Life Scale	Quality of Life	3, 6, 12 months
Primary	Stroke Impact Scale	Stroke recovery	3, 6, 12 months
Primary	NIH Stroke Scale	Stroke Severity	0, 3, months
Secondary	Medical Outcomes Study Social Support Scale	Social Support	3, 6, 12 months
Secondary	Patient Health Questionnaire-9	Depression	3, 6 12 months