Syntrillo Telehealth Stroke Risk Reduction Study

Syntrillo, Inc

Status

Not yet enrolling

Conditions

Hypertension

Stroke Prevention

Hypertension (HTN)

Cardiovascular Risk Factor

Treatments

Behavioral: Technology-enabled Telehealth Care Plan

Other: Secure Messaging Platforms (TigerConnect, Weave, AirCall)

Other: Healthie EHR

Procedure: Laboratory Blood Test Collection

Drug: Statin Medication Management

Device: Blood Pressure Monitoring Device

Device: Tenovi Smart Pillbox

Device: Wearable Activity Trackers (Fitbit or Apple Watch)

Drug: Antiplatelet or Anticoagulant Therapy

Drug: Antihypertensive Medication Management

Study type

Interventional

Funder types

Other

Identifiers

NCT07124728

2025003

Details and patient eligibility

About

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.

Full description

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.

Enrollment

68 estimated patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

68 participants in 1 patient group

Telemedicine Stroke Prevention Program

Experimental group

Description:

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.

Treatment: