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Completed

NCT Number: NCT02982278

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

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community-based Intervention under Nurse Guidance after Stroke

Behavioral

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.

Other names: CINGS

Primary outcomes

  1. Stroke Specific Quality of Life Scale

    Time frame: 3, 6, 12 months

    Quality of Life

  2. Stroke Impact Scale

    Time frame: 3, 6, 12 months

    Stroke recovery

  3. NIH Stroke Scale

    Time frame: 0, 3, months

    Stroke Severity

Secondary outcomes

  1. Medical Outcomes Study Social Support Scale

    Time frame: 3, 6, 12 months

    Social Support

  2. Patient Health Questionnaire-9

    Time frame: 3, 6 12 months

    Depression

Other outcomes

  1. Stroke Self-Efficacy Scale

    Time frame: 3, 6, 12

    Self-efficacy

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Acronym: CINGS

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2016
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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