Wide Spectrum Investigation of Stroke Outcome Disparities on Multiple Levels (WISSDOM)
CINGS
1 other identifier
interventional
87
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
December 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedFebruary 26, 2021
February 1, 2021
4.8 years
December 1, 2016
February 25, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Stroke Specific Quality of Life Scale
Quality of Life
3, 6, 12 months
Stroke Impact Scale
Stroke recovery
3, 6, 12 months
NIH Stroke Scale
Stroke Severity
0, 3, months
Secondary Outcomes (2)
Medical Outcomes Study Social Support Scale
3, 6, 12 months
Patient Health Questionnaire-9
3, 6 12 months
Other Outcomes (1)
Stroke Self-Efficacy Scale
3, 6, 12
Study Arms (2)
CINGS Intervention
EXPERIMENTALCINGS 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
EXPERIMENTALControl group will receive usual care. Base line visit and follow up at 3, 6, and 12 months post stroke enrollment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of South Carolinalead
- American Heart Associationcollaborator
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Related Publications (1)
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.
PMID: 32346280DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gayenell Magwood, PhD
Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2016
First Posted
December 5, 2016
Study Start
October 1, 2015
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
February 26, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share