Program to help stroke survivors manage their health
Improved Risk Factor Control Through a Transitional Care Program for Stroke Survivors
This study is testing a program that helps stroke survivors manage their health and reduce the risk of another stroke by using smart devices and working with healthcare providers, to see if starting right after leaving the hospital is more effective than starting later.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Syntrillo, Inc Academic / other |
| Locations | 1 site (Winchester, Virginia) |
| Trial ID | NCT06657235 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a transitional care program designed to assist stroke survivors in managing their risk factors to reduce the likelihood of a repeat stroke. Participants will track their medications, exercise, and health information using smart devices, while also engaging with healthcare providers and answering health-related questions. The study compares the effectiveness of the program based on the timing of enrollment, either immediately after hospital discharge or several months later, to determine the optimal approach for improving health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 and above who have experienced an ischemic stroke and have a modified Rankin score of 3 or less.
Not a fit: Patients with hemorrhagic strokes or those who lack the capacity to participate in the program will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly lower the risk of recurrent strokes in survivors by improving their management of health factors.
How similar studies have performed: Other studies have shown promise in transitional care programs for stroke survivors, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Winchester, Virginia
- Valley Health System — Winchester, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Research Coordinator
- Email: admin@syntrillo.com
- Phone: 434-202-3450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.