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STRIVE: Stroke Research Initiative to Advance Equity

Sponsor
Medstar Health Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06075719
Collaborator
(none)
1,000
Enrollment
72
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

  1. Assess patient-centered outcomes (PCOs) amongst stroke survivors and their caregivers in the MedStar Health system longitudinally.
  1. Utilize a community advisory board (CAB) of stroke survivors and their caregivers to identify the patient-centered outcome(s) that they determine to be most important and valuable to assess based on their lived experiences.
  1. Collect the chosen PCOs at multiple time points using an electronic survey tool (e.g. Qualtrics, Tonic or RedCap)

  1. Evaluate the impact of social determinants of health (SDoH) and experiences of discrimination on the chosen PCOs.

  2. Examine whether there are differences in long-term PCOs amongst stroke survivors from different racial and ethnic groups.

2.2 Hypothesis: We hypothesize that stroke survivors that come from historically marginalized populations, specifically African American and Latinos, will have lower patient-centered outcome scores overall as compared to their Caucasian counterparts. In addition, we hypothesize that the difference PCO scores between Caucasian and African American and Latino populations will be due in part to experienced discrimination and not SDoH alone.

.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Stroke Research Initiative to Advance Equity
    Anticipated Study Start Date :
    Oct 1, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2028
    Anticipated Study Completion Date :
    Oct 1, 2029

    Arms and Interventions

    Arm Intervention/Treatment
    Stroke Survivor

    Survivor of acute ischemic stroke or intracerebral hemorrhage in the last 6 weeks
    Caregiver

    Primary caregiver of stroke survivor

    Outcome Measures

    Primary Outcome Measures

    1. Patient-Centered Outcome Measures [5 years]

      Assess patient-centered outcomes (PCOs) amongst stroke survivors and their caregivers in the MedStar Health System longitudinally. Stroke Impact Scale and the Modified Caregiver Strain Index

    Secondary Outcome Measures

    1. Social Determinants of Health [5 years]

      Evaluate the impact of social determinants of health (SDoH) on the chosen PCOs.

    2. Discrimination [5 years]

      Evaluate the impact of patient-reported experiences of discrimination on the chosen PCOs.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Stroke Survivor:
    Inclusion Criteria:

    ≥ 18 years old Acute Ischemic Stroke (AIS) or Intracerebral Hemorrhage (ICH) patients that have been cared for in the MedStar Healthcare system AIS of ICH in the last six weeks Ability to communicate in English, Spanish, Amharic, Mandarin Chinese or French (most common languages in the greater Washington, DC area)

    Exclusion Criteria:

    Transient Ischemic Attack (TIA) or Subarachnoid Hemorrhage (SAH) Unable to complete required forms Life expectancy less than 6 months

    Caregiver Inclusion Criteria Age ≥ 18 Self-identify as primary caregiver for the stroke survivor Ability to communicate in English, Spanish, Amharic, Mandarin Chinese, French

    Exclusion Criteria Unable to complete study survey forms Life expectancy less than 6 months

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Medstar Health Research Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    M. Carter Denny, Principle Investigator, Medstar Health Research Institute
    ClinicalTrials.gov Identifier:
    NCT06075719
    Other Study ID Numbers:
    • STUDY00006503
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 10, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of Oct 10, 2023