Syntrillo Telehealth Stroke Risk Reduction Study
Impact of Syntrillo's Telehealth Service on Stroke Risk Factor Reduction in At-risk Patients
1 other identifier
interventional
68
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started Aug 2025
Shorter than P25 for not_applicable hypertension
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2025
CompletedFirst Submitted
Initial submission to the registry
August 8, 2025
CompletedFirst Posted
Study publicly available on registry
August 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedAugust 15, 2025
August 1, 2025
7 months
August 8, 2025
August 8, 2025
Conditions
Keywords
Outcome Measures
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.
Baseline to 6 months
Secondary Outcomes (6)
Change in Diastolic Blood Pressure
Baseline to 6 months
Change in Systolic Blood Pressure Variability
Baseline to 6 months
Change in Pulse Pressure
Baseline to 6 months
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Baseline to 6 months
Change in Resting Heart Rate
Baseline to 6 months
- +1 more secondary outcomes
Study Arms (1)
Telemedicine Stroke Prevention Program
EXPERIMENTALParticipants 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.
Interventions
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.
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.
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.
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.
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.
Participants and providers may communicate using secure messaging platforms for appointment reminders, assessments, and care support, to enhance participation engagement and care coordination.
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.
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.
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.
Blood samples may be collected at baseline and at 6 months to assess inflammation through high-sensitivity C-reactive protein.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Syntrillo, Inclead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2025
First Posted
August 15, 2025
Study Start
August 1, 2025
Primary Completion
March 1, 2026
Study Completion
May 1, 2026
Last Updated
August 15, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
De-identified data may be used internally for algorithm development and clinical workflow optimization, but will not be publicly shared.