Stroke Research Initiative to Advance Equity

Stroke Clinical Trial

— STRIVE  

Official title:

Stroke Research Initiative to Advance Equity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06075719
• Other study ID #: STUDY00006503
• Status: Not yet recruiting
• Start date: October 2023
• Est. completion date: October 2029

Study information

• Verified date: October 2023
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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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Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: October 2029
• Est. primary completion date: October 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-Centered Outcome Measures	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	5 years
Secondary	Social Determinants of Health	Evaluate the impact of social determinants of health (SDoH) on the chosen PCOs.	5 years
Secondary	Discrimination	Evaluate the impact of patient-reported experiences of discrimination on the chosen PCOs.	5 years