Recruiting

Observational Study

Sponsor:

Syntrillo, Inc

Code:

NCT06657235

Conditions

Stroke, Ischemic

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

Transitional Care Program

Study Details

Brief 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. 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

Conditions

Stroke, Ischemic

Study ID

NCT06657235

Start date

Aug 16, 2024

Status verified date

May, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

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:

1. offer a consistent choice about participating in the study
2. 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.

Study Design

Enrollment

224 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Early Enrollment

Participants enrolled around the time of discharge from the hospital immediately following an ischemic stroke.

experimental: Late Enrollment

Participants enrolled mainly between 3-5 months after their discharge from the hospital following an ischemic stroke.

Interventions

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 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 ]
  • 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 ]
  • Moderate intensity activity > 150 minutes per week on average [ Time Frame: 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 [ Time Frame: From enrollment to the end of the 6 month monitoring period ]
  • Adherence of antiplatelet, anticoagulant, and statin medications > 90% [ Time Frame: From enrollment to the end of the 6 month monitoring period ]

Central Contacts and Locations

Central contacts

Research Coordinator

434-202-3450admin@syntrillo.com

Locations

Valley Health System

Recruiting

Winchester, Virginia, United States, 22601

More Information

Sponsor

Syntrillo, Inc

Last update posted

Jun 3, 2025

Last verified

May, 2025

Keywords

  • transitional care program
  • secondary stroke prevention
  • stroke care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Syntrillo, Inc on 2025-06-03.