Stroke Research Initiative to Advance Equity (STRIVE)

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

Tracking Information

• First Submitted Date: October 4, 2023
• First Posted Date: October 10, 2023
• Last Update Posted Date: October 10, 2023
• Estimated Study Start Date: October 2023
• Estimated Primary Completion Date: October 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 4, 2023)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 4, 2023)

• Social Determinants of Health [ Time Frame: 5 years ]
  Evaluate the impact of social determinants of health (SDoH) on the chosen PCOs.
• Discrimination [ Time Frame: 5 years ]
  Evaluate the impact of patient-reported experiences of discrimination on the chosen PCOs.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Stroke Research Initiative to Advance Equity
• Official Title: Stroke Research Initiative to Advance Equity

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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• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Stroke Survivors from the MedStar Health System and their Caregivers.
• Condition: Stroke
• Intervention: Not Provided

Study Groups/Cohorts

• Stroke Survivor
  Survivor of acute ischemic stroke or intracerebral hemorrhage in the last 6 weeks
• Caregiver
  Primary caregiver of stroke survivor

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 4, 2023): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2029
• Estimated Primary Completion Date: October 2028 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06075719
• Other Study ID Numbers: STUDY00006503
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: M. Carter Denny, Medstar Health Research Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Medstar Health Research Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Medstar Health Research Institute
• Verification Date: October 2023