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Stroke Research Initiative to Advance Equity (STRIVE)

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ClinicalTrials.gov Identifier: NCT06075719
Recruitment Status : Not yet recruiting
First Posted : October 10, 2023
Last Update Posted : October 10, 2023
Sponsor:
Information provided by (Responsible Party):
M. Carter Denny, Medstar Health Research Institute

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

  1. Assess patient-centered outcomes (PCOs) amongst stroke survivors and their caregivers in the MedStar Health system longitudinally.

    i. 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.

    ii. Collect the chosen PCOs at multiple time points using an electronic survey tool (e.g. Qualtrics, Tonic or RedCap)

  2. Evaluate the impact of social determinants of health (SDoH) and experiences of discrimination on the chosen PCOs.
  3. 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.

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Condition or disease
Stroke

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stroke Research Initiative to Advance Equity
Estimated Study Start Date : October 2023
Estimated Primary Completion Date : October 2028
Estimated Study Completion Date : October 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Groups and Cohorts
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Group/Cohort
Stroke Survivor
Survivor of acute ischemic stroke or intracerebral hemorrhage in the last 6 weeks
Caregiver
Primary caregiver of stroke survivor


Outcome Measures
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Primary Outcome Measures :
  1. Patient-Centered Outcome Measures [ Time Frame: 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 [ Time Frame: 5 years ]
    Evaluate the impact of social determinants of health (SDoH) on the chosen PCOs.

  2. Discrimination [ Time Frame: 5 years ]
    Evaluate the impact of patient-reported experiences of discrimination on the chosen PCOs.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stroke Survivors from the MedStar Health System and their Caregivers.
Criteria

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
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: M. Carter Denny, Principle Investigator, Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT06075719    
Other Study ID Numbers: STUDY00006503
First Posted: October 10, 2023    Key Record Dates
Last Update Posted: October 10, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases