Syntrillo Telehealth Stroke Risk Reduction Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorSyntrillo, Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age greater than or equal to 30
Diagnosis of hypertension
Dtrial fibrillation
Diabetes
Disqualifiers
History of stroke or TIA
Inability to consent or understand study
Residence in long-term acute care facility
Inability to ambulate independently
Trial design
Design model
Single group
Treatments tested in this trial
Technology-enabled Telehealth Care Plan
BehavioralParticipants 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
DeviceParticipants 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
DeviceParticipants 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)
DeviceParticipants 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
Other interventionHIPAA-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)
Other interventionParticipants 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
DrugParticipants 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
DrugLipid-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
DrugParticipants 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
Procedure/SurgeryBlood samples may be collected at baseline and at 6 months to assess inflammation through high-sensitivity C-reactive protein.
Treatment groups
68 Participants
are divided into 1 treatment groupGroup A: Telemedicine Stroke Prevention ProgramExperimental treatment 10 interventions
Trial outcomes
Primary outcomes
1
Change in Systolic Blood Pressure
This measure evaluates the average change in systolic blood pressure (SBP), which is the pressure in the arteries when the heart beats. Blood pressure is measured by participants at home using a Tenovi FDA-cleared digital blood pressure monitor. Baseline SBP is calculated using the first 10 valid readings taken during the initial week of monitoring. The 6-month value is calculated from the last 10 valid readings taken in the final week of the intervention. The study aims to observe a reduction of at least 10 mmHg in average SBP over the intervention period.
Time frame
Baseline to 6 monthsSecondary outcomes
1
Change in Diastolic Blood Pressure
This measure evaluates the average change in systolic blood pressure (SBP), which is the pressure in the arteries when the heart beats. Blood pressure is measured by participants at home using a Tenovi FDA-cleared digital blood pressure monitor. Baseline SBP is calculated using the first 10 valid readings taken during the initial week of monitoring. The 6-month value is calculated from the last 10 valid readings taken in the final week of the intervention. The study aims to observe a reduction of at least 10 mmHg in average SBP over the intervention period.
Time frame
Baseline to 6 months2
Change in Systolic Blood Pressure Variability
This measure assesses the variability of systolic blood pressure (SBP) as measured by the standard deviation (SD) of SBP readings. Variability is calculated from 20 readings collected at baseline (first 2 weeks) and another 20 readings at the end of the intervention (final 2 weeks). Measurements are taken using the Tenovi home blood pressure monitor. The target is a 10% reduction in the standard deviation of SBP values, indicating more stable blood pressure control.
Time frame
Baseline to 6 months3
Change in Pulse Pressure
This measure evaluates the change in pulse pressure (PP), defined as the difference between systolic and diastolic blood pressure. PP is a marker of arterial stiffness and cardiovascular risk. It is calculated from 20 home blood pressure readings collected at the start and again at the end of the 6-month intervention. Measurements are obtained using the Tenovi device. The study target is a reduction of at least 5 mmHg in average pulse pressure.
Time frame
Baseline to 6 months4
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
This measure examines changes in high-sensitivity C-reactive protein (hs-CRP), a blood marker of systemic inflammation and cardiovascular risk. hs-CRP levels are measured from blood samples collected at baseline and again at the 6-month time point. The study aims to observe a mean reduction of at least 20% in hs-CRP concentration over the course of the intervention.
Time frame
Baseline to 6 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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