Impact of Syntrillo's Telehealth Service on Stroke Risk Factor Reduction in At-risk Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Change in Systolic Blood Pressure
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age greater than or equal to 30
- •Diagnosis of hypertension
- •One or more of the following:
- •Dtrial fibrillation
- •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
Arms & Interventions
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.
Intervention: Laboratory Blood Test Collection (Procedure)
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.
Intervention: Wearable Activity Trackers (Fitbit or Apple Watch) (Device)
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.
Intervention: Healthie EHR (Other)
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.
Intervention: Secure Messaging Platforms (TigerConnect, Weave, AirCall) (Other)
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.
Intervention: Antihypertensive Medication Management (Drug)
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.
Intervention: Statin Medication Management (Drug)
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.
Intervention: Antiplatelet or Anticoagulant Therapy (Drug)
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.
Intervention: Tenovi Smart Pillbox (Device)
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.
Intervention: Technology-enabled Telehealth Care Plan (Behavioral)
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.
Intervention: Blood Pressure Monitoring Device (Device)
Outcomes
Primary Outcomes
Change in Systolic Blood Pressure
Time Frame: Baseline to 6 months
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.
Secondary Outcomes
- Change in Diastolic Blood Pressure(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)
- Change in Systolic Blood Pressure Variability(Baseline to 6 months)
- Change in Heart Rate Variability(Baseline to 6 months)