Study Results
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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NOT_YET_RECRUITING
NA
68 participants
INTERVENTIONAL
2025-08-31
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Laboratory Blood Test Collection
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.
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.
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.
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.
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.
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.
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.
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.
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.
Laboratory Blood Test Collection
Blood samples may be collected at baseline and at 6 months to assess inflammation through high-sensitivity C-reactive protein.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
ALL
No
Sponsors
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Syntrillo, Inc
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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2025003
Identifier Type: -
Identifier Source: org_study_id
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