Syntrillo Telehealth Stroke Risk Reduction Study

NCT ID: NCT07124728

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-05-31

Brief Summary

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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

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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

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Hypertension Hypertension (HTN) Stroke Prevention Cardiovascular Risk Factor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Telemedicine Stroke Prevention Program

Participants will receive a 6-month personalized telehealth intervention including remote patient monitoring, blood pressure management, lifestyle counseling, wearable monitoring, and multidisciplinary telemedicine visits via the Healthie platform.

Group Type EXPERIMENTAL

Technology-enabled Telehealth Care Plan

Intervention Type BEHAVIORAL

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.

Blood Pressure Monitoring Device

Intervention Type 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.

Tenovi Smart Pillbox

Intervention Type DEVICE

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.

Wearable Activity Trackers (Fitbit or Apple Watch)

Intervention Type DEVICE

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.

Healthie EHR

Intervention Type OTHER

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.

Secure Messaging Platforms (TigerConnect, Weave, AirCall)

Intervention Type OTHER

Participants and providers may communicate using secure messaging platforms for appointment reminders, assessments, and care support, to enhance participation engagement and care coordination.

Antihypertensive Medication Management

Intervention Type DRUG

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.

Statin Medication Management

Intervention Type DRUG

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.

Antiplatelet or Anticoagulant Therapy

Intervention Type DRUG

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.

Laboratory Blood Test Collection

Intervention Type PROCEDURE

Blood samples may be collected at baseline and at 6 months to assess inflammation through high-sensitivity C-reactive protein.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

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.

Intervention Type 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.

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Laboratory Blood Test Collection

Blood samples may be collected at baseline and at 6 months to assess inflammation through high-sensitivity C-reactive protein.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age greater than or equal to 30
* Diagnosis of hypertension
* One or more of the following:
* Dtrial fibrillation
* Diabetes
* Chronic kidney disease (stage 2+)
* Obesity (class 2+)
* Obstructive sleep apnea
* Coronary artery disease
* Hyperlipidemia
* Carotid stenosis (greater than or equal to 50%)
* Congestive heart failure

Exclusion Criteria

* History of stroke or TIA
* Inability to consent or understand study
* Residence in long-term acute care facility
* Inability to ambulate independently
* Non-English speaking
* No internet access
* Not residing in Virginia
* Pregnancy or suspected pregnancy
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Syntrillo, Inc

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Research Coordinator

Role: CONTACT

434-202-3450

Other Identifiers

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2025003

Identifier Type: -

Identifier Source: org_study_id

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