NCT06657235 · Syntrillo, Inc
Transitional Care Program to Improve Risk Factors in Stroke Survivors
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Transitional Care Program
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
Exclusion criteria
- 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.
- 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.
Where
- Winchester, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2025 · Source of record for eligibility and locations