NCT07124728

Syntrillo Telehealth Stroke Risk Reduction Study

Impact of Syntrillo's Telehealth Service on Stroke Risk Factor Reduction in At-risk Patients

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Syntrillo, Inc · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single-arm, open-label study evaluating the impact of Syntrillo's telehealth program on stroke risk factors, particularly blood pressure, among 68 high-risk patients. The 6-month intervention includes personalized remote care with blood pressure monitoring, wearable tracking, and multidisciplinary telehealth visits.

Detailed description

Participants ≥30 years old with hypertension and at least one of the following conditions: atrial fibrillation, diabetes, chronic kidney disease (stage 2 or higher), obesity (class 2 or higher), obstructive sleep apnea, coronary artery disease, hyperlipidemia, carotid stenosis (of 50% or greater), and/or congestive heart failure will be enrolled in a 6-month telehealth intervention focused on stroke risk reduction. The program includes use of home blood pressure monitors, smart pillboxes, wearable activity trackers, and a multidisciplinary team for personalized care. Primary endpoint is change in systolic blood pressure. Additional endpoints include diastolic BP, inflammatory markers (hs-CRP), and cardiovascular biomarkers (resting heart rate, HRV). The study is single-arm, non-randomized, and exploratory in design.

Conditions

• Hypertension
• Hypertension (HTN)
• Stroke Prevention
• Cardiovascular Risk Factor

Interventions

Type	Name	Description
BEHAVIORAL	Technology-enabled Telehealth Care Plan	Participants receive a 6 month personalized telehealth intervention via a multidisciplinary care team, delivering care via a secure digital platform, including education, risk assessment, lifestyle coaching, medical history review, and stroke risk reduction planning. The Healthie EHR is used for communication, documentation, and data integration. Syntrillo Navigators and neurology providers conduct onboarding, telemedicine visits, and coordination with patient's primary care providers and care team.
DEVICE	Blood Pressure Monitoring Device	Participants will receive a cellular-enabled, FDA-cleared blood pressure monitor supplied by Tenovi. Blood pressure is measured twice daily during baseline and at least once daily throughout the 6-month intervention. Data is transmitted via a secure gateway to the Healthie EHR for real-time monitoring and analysis.
DEVICE	Tenovi Smart Pillbox	Participants receive a connected 7-day smart pillbox that detects compartment openings and refills. Medication adherence data is uploaded in real time to a secure dashboard and integrated into the EHR.
DEVICE	Wearable Activity Trackers (Fitbit or Apple Watch)	Participants will utilize a commercially available wearable activity tracker to monitor step counts, resting heart rate, and heart rate variability. This data is integrated into the EHR. Devices will be provided if participants do not already own one.
OTHER	Healthie EHR	HIPAA-compliant electronic medical record system used for participant management, secure communication, clinical documentation, and device data integration, consisting of custom workflows used for risk tracking and care planning.
OTHER	Secure Messaging Platforms (TigerConnect, Weave, AirCall)	Participants and providers may communicate using secure messaging platforms for appointment reminders, assessments, and care support, to enhance participation engagement and care coordination.
DRUG	Antihypertensive Medication Management	Participants may be prescribed or have existing antihypertensive regimens adjusted (ACE inhibitors, beta blockers, calcium channel blockers, diuretics, etc) by neurologists or nurse practitioners based on individual risk assessments and clinical findings during the study. Changed will be recorded in EHR.
DRUG	Statin Medication Management	Lipid-lowering medications, including statins, may be initiated or adjusted as part of participants' care plans. Medication use is guided by cardiovascular risk and AHA guidelines. Changed will be recorded in EHR.
DRUG	Antiplatelet or Anticoagulant Therapy	Participants with atrial fibrillation or elevated cardiovascular risk may be started on or have changes to antiplatelet or anticoagulant therapy. Medication decisions are made by neurologist or nurse practitioners during telemedicine visits. Changed will be recorded in EHR.
PROCEDURE	Laboratory Blood Test Collection	Blood samples may be collected at baseline and at 6 months to assess inflammation through high-sensitivity C-reactive protein.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2025-08-15
• Last updated: 2025-08-15