Wide Spectrum Investigation of Stroke Outcome Disparities on Multiple Levels (WISSDOM) (CINGS)
Primary Purpose
Stroke Ischemic, Minority Health
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community-based Intervention under Nurse Guidance after Stroke
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke Ischemic
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
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CINGS Intervention
Control
Arm 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.
Control group will receive usual care. Base line visit and follow up at 3, 6, and 12 months post stroke enrollment.
Outcomes
Primary Outcome Measures
Stroke Specific Quality of Life Scale
Quality of Life
Stroke Impact Scale
Stroke recovery
NIH Stroke Scale
Stroke Severity
Secondary Outcome Measures
Medical Outcomes Study Social Support Scale
Social Support
Patient Health Questionnaire-9
Depression
Full Information
NCT ID
NCT02982278
First Posted
December 1, 2016
Last Updated
February 25, 2021
Sponsor
Medical University of South Carolina
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT02982278
Brief Title
Wide Spectrum Investigation of Stroke Outcome Disparities on Multiple Levels (WISSDOM)
Acronym
CINGS
Official Title
Wide Spectrum Investigation of Stroke Outcome Disparities on Multiple Levels (WISSDOM): Community-based Intervention Under Nurse Guidance
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
American Heart Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Ischemic, Minority Health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CINGS Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Experimental
Arm Description
Control group will receive usual care. Base line visit and follow up at 3, 6, and 12 months post stroke enrollment.
Intervention Type
Behavioral
Intervention Name(s)
Community-based Intervention under Nurse Guidance after Stroke
Other Intervention Name(s)
CINGS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stroke Specific Quality of Life Scale
Description
Quality of Life
Time Frame
3, 6, 12 months
Title
Stroke Impact Scale
Description
Stroke recovery
Time Frame
3, 6, 12 months
Title
NIH Stroke Scale
Description
Stroke Severity
Time Frame
0, 3, months
Secondary Outcome Measure Information:
Title
Medical Outcomes Study Social Support Scale
Description
Social Support
Time Frame
3, 6, 12 months
Title
Patient Health Questionnaire-9
Description
Depression
Time Frame
3, 6 12 months
Other Pre-specified Outcome Measures:
Title
Stroke Self-Efficacy Scale
Description
Self-efficacy
Time Frame
3, 6, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gayenell Magwood, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32346280
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.
Results Reference
derived
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Wide Spectrum Investigation of Stroke Outcome Disparities on Multiple Levels (WISSDOM)
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