Syntrillo Telehealth Stroke Risk Reduction Study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Syntrillo, Inc

  lead OTHER

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-31

Primary Completion

2026-03-31

Completion

2026-05-31