StrokeSTRIVENCT06075719
Stroke Research Initiative to Advance Equity
An observational study of Stroke, run by Medstar Health Research Institute at 2 sites in United States.
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 the CAB determine to be most important and valuable… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jan 2024to 15 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke Survivors from the MedStar Health System and their Caregivers.
Who may be able to join
- ≥ 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)
- Age ≥ 18
- Self-identify as primary caregiver for the stroke survivor
- Ability to communicate in English, Spanish, Amharic, Mandarin Chinese, French
Who cannot join
- Transient Ischemic Attack (TIA) or Subarachnoid Hemorrhage (SAH)
- Unable to complete required forms
- Life expectancy less than 6 months
- Caregiver
- Unable to complete study survey forms
- Life expectancy less than 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MedStar National Rehabilitation Hopsital
Washington D.C., District of Columbia, 20010
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
- Assess patient-centered outcomes (PCOs) amongst stroke survivors and their caregivers in the MedStar Health system longitudinally.
- 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.
.
- Conditions
- Stroke
- Keywords
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke Survivor | Survivor of acute ischemic stroke or intracerebral hemorrhage in the last 6 weeks | |
| Caregiver | Primary caregiver of stroke survivor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (2)
Social Determinants of Health
Evaluate the impact of social determinants of health (SDoH) on the chosen PCOs.
Measured: 5 years
Discrimination
Evaluate the impact of patient-reported experiences of discrimination on the chosen PCOs.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start10 Jan 2024
- Primary completion15 Mar 2026
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Carter Denny, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075719
- Sponsor's protocol ID
- STUDY00006503
- Acronym
- STRIVE
- Status last verified
- Nov 2025
- First submitted
- 4 Oct 2023
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Research Initiative to Advance Equity
- ClinicalTrials.gov ID
- NCT06075719
- Acronym / sponsor ID
- STRIVE / STUDY00006503
- Conditions
- Stroke
- Keywords
- Stroke
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Assess patient-centered outcomes (PCOs) amongst stroke survivors and their caregivers in the MedStar Health system longitudinally.
- 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.
.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke Survivor | – | –Survivor of acute ischemic stroke or intracerebral hemorrhage in the last 6 weeks |
| Caregiver | – | –Primary caregiver of stroke survivor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke Survivors from the MedStar Health System and their Caregivers.
Key inclusion criteria (7 listed)
- ≥ 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)
- Age ≥ 18
Key exclusion criteria (6 listed)
- Transient Ischemic Attack (TIA) or Subarachnoid Hemorrhage (SAH)
- Unable to complete required forms
- Life expectancy less than 6 months
- Caregiver
- Unable to complete study survey forms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Social Determinants of Health
Time frame: 5 years
Discrimination
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Medstar Health Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Centered Outcome Measures (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.