Stroke, IschemicNCT06657235
Transitional Care Program to Improve Risk Factors in Stroke Survivors
A study testing Transitional Care Program in people with Stroke, Ischemic, run by Syntrillo, Inc at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate whether our transitional care program helps stroke survivors better manage their risk factors for stroke to lower the risk of a repeat stroke. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Transitional Care Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2024to Dec 2025
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Cohorts:
- Age 30 or above
- Evidence of ischemic stroke documented on CT or MRI
- Modified Rankin score of 3 or less
- Early Enrollment:
- Admission for ischemic stroke at a participating site
Show all 10Show fewer
- Enrolled during their admission for ischemic stroke or within 24 hours of discharge
- Late Enrollment:
- Stroke survivors previously admitted at the participating sites' inpatient stroke unit
- Enrollment date between 1 and 6 months after discharge for inpatient admission for ischemic stroke
Who cannot join
- Participants determined to have hemorrhagic or periprocedural stroke based on hospital EMR review will be excluded.
- Participants determined to have an ischemic stroke due to dissection based on hospital EMR review will be excluded.
- Participants who lack capacity determined by the care team during their hospitalization (for the early enrollment group) or their most recent clinical encounter (for the late enrollment group) will be excluded.
- Participants with a diagnosis of dementia will be excluded.
- Participants with acute subdural hemorrhage will be excluded.
- Participants with hemorrhagic stroke due to vascular abnormality (aneurysm or AVM) or trauma will be excluded.
Show all 14Show fewer
- Participants who cannot perform the following will be excluded:
- offer a consistent choice about participating in the study
- demonstrate that they can comprehend and recall major features of the study including: participation is voluntary, the major procedures, the primary risk, and the primary benefit.
- Participants who are discharged to Long-term Acute Care Hospitals will be excluded.
- Participants who are unable to read or communicate fluently in English will be excluded.
- Participants who do not have reliable internet access to complete telemedicine visits per self-report will be excluded.
- Participants already enrolled in another clinical study which could impact the frequency of monitoring or care that participant receives.
- Participants who do not reside in Virginia, West Virginia, Tennessee, Oklahoma, Illinois, or Michigan will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Valley Health System
Winchester, Virginia, 22601
About this study
Official title: Improved Risk Factor Control Through a Transitional Care Program for Stroke Survivors
The goal of this clinical trial is to evaluate whether our transitional care program helps stroke survivors better manage their risk factors for stroke to lower the risk of a repeat stroke. The main question it aims to answer is:
- Does the program help participants meet the targets set by the American Heart Association clinical guidelines for control of risk factors associated with stroke?
Read more
Researchers will compare participants enrolled right after being discharged from the hospital to participants enrolled around 3-5 months after being discharged to examine whether timing differences in enrollment affect the efficacy of the program.
Participants will:
- Keep track of their medications, their exercise, and their health information using smart devices provided by the study
- Answer questions about their health and lifestyle
- Meet with our team of healthcare providers
- Conditions
- Stroke, Ischemic
- Being tested
- Transitional Care Program
- Keywords
- transitional care program, secondary stroke prevention, stroke care
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitional Care ProgramOther
Participants will receive personalized risk-factor management stroke care from a multidisciplinary team trained by our neurologists to understand the needs of stroke survivors and the nuances of stroke care. Risk factor data from in-home devices, health records, and self-reports will be collected along with functional status and behavioral data obtained through validated questionnaires and an occupational therapy evaluation. Syntrillo's neurology provider will review this data, assess the participant through a telemedicine encounter, and create a comprehensive secondary prevention plan to supplement the participant's care plan at discharge. Data generated through these clinical encounters will be de-identified and used for subsequent development of Syntrillo's stroke management technology.
| Study group | Role | What they receive |
|---|---|---|
| Early Enrollment | Experimental | Participants enrolled around the time of discharge from the hospital immediately following an ischemic stroke. Receives: Other: Transitional Care Program |
| Late Enrollment | Experimental | Participants enrolled mainly between 3-5 months after their discharge from the hospital following an ischemic stroke. Receives: Other: Transitional Care Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased compliance with therapeutic standards of care according to the American Heart Association (AHA) guidelines for secondary stroke prevention in early vs late group
We will measure percent compliance with AHA therapeutic standards in the early enrollment group compared to the anticipated baseline percent compliance in the late enrollment group at equivalent time points post-discharge. Percent compliance is a composite endpoint. Participants will be considered "compliant" to secondary stroke prevention guidelines if all other conditions below (2-5) are met. Participants will be considered "non-compliant" to secondary stroke prevention guidelines if one or more conditions are not met.
Measured: From enrollment to the end of the 6 month monitoring period
90% of systolic blood pressure (SBP) readings < 130 mmHg AND 90% of diastolic blood pressure (DBP) readings < 80 mmHg in a one week period
Blood pressure will be measured using Tenovi's FDA-cleared, portable home blood pressure monitoring device. Both systolic and diastolic measurements must be below the threshold in order for the condition to be met.
Measured: From enrollment to the end of the 6 month monitoring period
Moderate intensity activity > 150 minutes per week on average
Physical activity will be assessed through a combination of self-reported and biometric data. We will administer a physical activity questionnaire and correlate self-reported activity with biometric data obtained from the smartwatch to estimate physical activity and assess confidence level in the data.
Measured: From enrollment to the end of the 6 month monitoring period
Correct prescription of antiplatelet, anticoagulant, and statin medications per guidelines when no contraindications are present
We will verify correct prescriptions and dosing through EHR records, pharmacy records, and/or patient self-report as applicable. Correct prescription and dosing will be determined through expert opinion following AHA therapeutic standards.
Measured: From enrollment to the end of the 6 month monitoring period
Adherence of antiplatelet, anticoagulant, and statin medications > 90%
Adherence is determined by percent of missed doses per week. Medication adherence will be monitored through a combination of self-report, device data, and pharmacy records, as applicable. We will administer the 5-Item Medication Adherence Report Scale (MARS-5) and correlate self-reported data with device data from Tenovi's smart pillbox and pharmacy records to estimate percent adherence and assess confidence level in the data.
Measured: From enrollment to the end of the 6 month monitoring period
Secondary outcomes (3)
Average change in compliance percentage at 1, 2, and 3 months following initiation of our transitional care program
Compliance percent is measured based on the data collected from the four primary outcome measures as described in the primary outcomes.
Measured: From enrollment to the end of the 6 month monitoring period
Frequency of recurrent stroke in the early enrollment cohort compared to the late enrollment cohort at equivalent time points post-discharge
Highest risk for recurrent stroke is in the initial 6 months following the first stroke. Frequency of recurrent stroke will be measured by aggregating the number of patients readmitted to the hospital within 6 months following enrollment based on EHR records and/or patient self-report.
Measured: From enrollment to the end of the 6 month monitoring period
Frequency of readmission in the in the early enrollment cohort compared to the late enrollment cohort at equivalent time points post-discharge
Highest risk for recurrent stroke is in the initial 6 months following the first stroke. Frequency of recurrent stroke will be measured by aggregating the number of patients readmitted to the hospital within 6 months following enrollment based on EHR records and/or patient self-report.
Measured: From enrollment to the end of the 6 month monitoring period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start16 Aug 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syntrillo, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657235
- Sponsor's protocol ID
- 2024002
- Status last verified
- May 2025
- First submitted
- 15 Oct 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Risk Factor Control Through a Transitional Care Program for Stroke Survivors
- ClinicalTrials.gov ID
- NCT06657235
- Acronym / sponsor ID
- 2024002
- Conditions
- Stroke, Ischemic
- Keywords
- transitional care program, secondary stroke prevention, stroke care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Syntrillo, IncUniversity, hospital or other
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Oct 2024 (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.
The goal of this clinical trial is to evaluate whether our transitional care program helps stroke survivors better manage their risk factors for stroke to lower the risk of a repeat stroke. The main question it aims to answer is:
- Does the program help participants meet the targets set by the American Heart Association clinical guidelines for control of risk factors associated with stroke?
Researchers will compare participants enrolled right after being discharged from the hospital to participants enrolled around 3-5 months after being discharged to examine whether timing differences in enrollment affect the efficacy of the program.
Participants will:
- Keep track of their medications, their exercise, and their health information using smart devices provided by the study
- Answer questions about their health and lifestyle
- Meet with our team of healthcare providers
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Enrollment | Experimental | Other: Transitional Care ProgramParticipants enrolled around the time of discharge from the hospital immediately following an ischemic stroke. |
| Late Enrollment | Experimental | Other: Transitional Care ProgramParticipants enrolled mainly between 3-5 months after their discharge from the hospital following an ischemic stroke. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 30 or above
- Evidence of ischemic stroke documented on CT or MRI
- Modified Rankin score of 3 or less
- Admission for ischemic stroke at a participating site
- Enrolled during their admission for ischemic stroke or within 24 hours of discharge
Key exclusion criteria (14 listed)
- Participants determined to have hemorrhagic or periprocedural stroke based on hospital EMR review will be excluded.
- Participants determined to have an ischemic stroke due to dissection based on hospital EMR review will be excluded.
- Participants who lack capacity determined by the care team during their hospitalization (for the early enrollment group) or their most recent clinical encounter (for the late enrollment group) will be excluded.
- Participants with a diagnosis of dementia will be excluded.
- Participants with acute subdural hemorrhage will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transitional Care ProgramParticipants will receive personalized risk-factor management stroke care from a multidisciplinary team trained by our neurologists to understand the needs of stroke survivors and the nuances of stroke care. Risk factor data from in-home devices, health records, and self-reports will be collected along with functional status and behavioral data obtained through validated questionnaires and an occupational therapy evaluation. Syntrillo's neurology provider will review this data, assess the participant through a telemedicine encounter, and create a comprehensive secondary prevention plan to supplement the participant's care plan at discharge. Data generated through these clinical encounters will be de-identified and used for subsequent development of Syntrillo's stroke management technology. | Other | Early Enrollment, Late Enrollment |
Primary outcome
Increased compliance with therapeutic standards of care according to the American Heart Association (AHA) guidelines for secondary stroke prevention in early vs late group
Time frame: From enrollment to the end of the 6 month monitoring period
We will measure percent compliance with AHA therapeutic standards in the early enrollment group compared to the anticipated baseline percent compliance in the late enrollment group at equivalent time points post-discharge. Percent compliance is a composite endpoint. Participants will be considered "compliant" to secondary stroke prevention guidelines if all other conditions below (2-5) are met. Participants will be considered "non-compliant" to secondary stroke prevention guidelines if one or more conditions are not met.
90% of systolic blood pressure (SBP) readings < 130 mmHg AND 90% of diastolic blood pressure (DBP) readings < 80 mmHg in a one week period
Time frame: From enrollment to the end of the 6 month monitoring period
Blood pressure will be measured using Tenovi's FDA-cleared, portable home blood pressure monitoring device. Both systolic and diastolic measurements must be below the threshold in order for the condition to be met.
Moderate intensity activity > 150 minutes per week on average
Time frame: From enrollment to the end of the 6 month monitoring period
Physical activity will be assessed through a combination of self-reported and biometric data. We will administer a physical activity questionnaire and correlate self-reported activity with biometric data obtained from the smartwatch to estimate physical activity and assess confidence level in the data.
Correct prescription of antiplatelet, anticoagulant, and statin medications per guidelines when no contraindications are present
Time frame: From enrollment to the end of the 6 month monitoring period
We will verify correct prescriptions and dosing through EHR records, pharmacy records, and/or patient self-report as applicable. Correct prescription and dosing will be determined through expert opinion following AHA therapeutic standards.
Adherence of antiplatelet, anticoagulant, and statin medications > 90%
Time frame: From enrollment to the end of the 6 month monitoring period
Adherence is determined by percent of missed doses per week. Medication adherence will be monitored through a combination of self-report, device data, and pharmacy records, as applicable. We will administer the 5-Item Medication Adherence Report Scale (MARS-5) and correlate self-reported data with device data from Tenovi's smart pillbox and pharmacy records to estimate percent adherence and assess confidence level in the data.
3 secondary outcomes
Average change in compliance percentage at 1, 2, and 3 months following initiation of our transitional care program
Time frame: From enrollment to the end of the 6 month monitoring period
Frequency of recurrent stroke in the early enrollment cohort compared to the late enrollment cohort at equivalent time points post-discharge
Time frame: From enrollment to the end of the 6 month monitoring period
Frequency of readmission in the in the early enrollment cohort compared to the late enrollment cohort at equivalent time points post-discharge
Time frame: From enrollment to the end of the 6 month monitoring period
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 3 Jun 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitional Care Program in people with Stroke, Ischemic, run by Syntrillo, Inc at 1 site 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 10 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Research Coordinator (434-202-3450, admin@syntrillo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased compliance with therapeutic standards of care according to the American Heart Association (AHA) guidelines for secondary stroke prevention in early vs late group (time frame: From enrollment to the end of the 6 month monitoring period). The study lists 5 primary outcomes in all. 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 3 Jun 2025; AzTrials last refreshed its copy on 2 Nov 2026.