Stroke Research Initiative to Advance Equity | NCT06075719

Studies
Stroke Research Initiative to Advance Equity

NCT06075719

Sponsor

Medstar Health Research Institute

Status

Active, not recruiting

Last Update Posted

Apr 2, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2024Actual

Primary Completion Date

Mar 15, 2026Actual

Completion Date

Jun 15, 2026Estimated

First Submitted Date

Oct 4, 2023

First Submission Date that Met QC Criteria

Oct 4, 2023

First Posted Date

Oct 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2026

Last Update Posted Date

Apr 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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 the CAB 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)
Evaluate the impact of social determinants of health (SDoH) and experiences of discrimination on the chosen PCOs.
Examine whether there are differences in long-term PCOs amongst stroke survivors from different racial and ethnic groups.

2.2 Hypothesis: The investigator hypothesizes 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, the investigator hypothesizes 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stroke Survivor		Survivor of acute ischemic stroke or intracerebral hemorrhage in the last 6 weeks
Caregiver		Primary caregiver of stroke survivor

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Stroke Survivors from the MedStar Health System and their Caregivers.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MedStar National Rehabilitation Hopsital		Washington D.C.	District of Columbia	20010	United States

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided