Transitional Care Program to Improve Risk Factors in Stroke Survivors
ConditionStroke, Ischemic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorSyntrillo, Inc
About this trial
The goal of this clinical trial is to evaluate whether our transitional care program helps stroke survivors better manage their risk factors for stroke to lower the risk of a repeat stroke. The main question it aims to answer is:
\- Does the program help participants meet the targets set by the American Heart Association clinical guidelines for control of risk factors associated with stroke?
Researchers will compare participants enrolled right after being discharged from the hospital to participants enrolled around 3-5 months after being discharged to examine whether timing differences in enrollment affect the efficacy of the program.
Participants will:
* Keep track of their medications, their exercise, and their health information using smart devices provided by the study * Answer questions about their health and lifestyle * Meet with our team of healthcare providers
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 30 or above
Evidence of ischemic stroke documented on CT or MRI
Modified Rankin score of 3 or less
Admission for ischemic stroke at a participating site
Disqualifiers
Participants determined to have hemorrhagic or periprocedural stroke based on hospital EMR review will be excluded.
Participants determined to have an ischemic stroke due to dissection based on hospital EMR review will be excluded.
Participants who lack capacity determined by the care team during their hospitalization (for the early enrollment group) or their most recent clinical encounter (for the late enrollment group) will be excluded.
Participants with a diagnosis of dementia will be excluded.
Trial design
Design model
Parallel
Treatments tested in this trial
Transitional Care Program
Other interventionParticipants will receive personalized risk-factor management stroke care from a multidisciplinary team trained by our neurologists to understand the needs of stroke survivors and the nuances of stroke care. Risk factor data from in-home devices, health records, and self-reports will be collected along with functional status and behavioral data obtained through validated questionnaires and an occupational therapy evaluation. Syntrillo's neurology provider will review this data, assess the participant through a telemedicine encounter, and create a comprehensive secondary prevention plan to supplement the participant's care plan at discharge. Data generated through these clinical encounters will be de-identified and used for subsequent development of Syntrillo's stroke management technology.
Treatment groups
224 Participants
are divided into 2 treatment groupsGroup A: Early EnrollmentExperimental treatment 1 intervention
Group B: Late EnrollmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Increased compliance with therapeutic standards of care according to the American Heart Association (AHA) guidelines for secondary stroke prevention in early vs late group
We will measure percent compliance with AHA therapeutic standards in the early enrollment group compared to the anticipated baseline percent compliance in the late enrollment group at equivalent time points post-discharge. Percent compliance is a composite endpoint. Participants will be considered "compliant" to secondary stroke prevention guidelines if all other conditions below (2-5) are met. Participants will be considered "non-compliant" to secondary stroke prevention guidelines if one or more conditions are not met.
Time frame
From enrollment to the end of the 6 month monitoring period2
90% of systolic blood pressure (SBP) readings < 130 mmHg AND 90% of diastolic blood pressure (DBP) readings < 80 mmHg in a one week period
Blood pressure will be measured using Tenovi's FDA-cleared, portable home blood pressure monitoring device. Both systolic and diastolic measurements must be below the threshold in order for the condition to be met.
Time frame
From enrollment to the end of the 6 month monitoring period3
Moderate intensity activity > 150 minutes per week on average
Physical activity will be assessed through a combination of self-reported and biometric data. We will administer a physical activity questionnaire and correlate self-reported activity with biometric data obtained from the smartwatch to estimate physical activity and assess confidence level in the data.
Time frame
From enrollment to the end of the 6 month monitoring period4
Correct prescription of antiplatelet, anticoagulant, and statin medications per guidelines when no contraindications are present
We will verify correct prescriptions and dosing through EHR records, pharmacy records, and/or patient self-report as applicable. Correct prescription and dosing will be determined through expert opinion following AHA therapeutic standards.
Time frame
From enrollment to the end of the 6 month monitoring periodSecondary outcomes
1
Average change in compliance percentage at 1, 2, and 3 months following initiation of our transitional care program
Compliance percent is measured based on the data collected from the four primary outcome measures as described in the primary outcomes.
Time frame
From enrollment to the end of the 6 month monitoring period2
Frequency of recurrent stroke in the early enrollment cohort compared to the late enrollment cohort at equivalent time points post-discharge
Highest risk for recurrent stroke is in the initial 6 months following the first stroke. Frequency of recurrent stroke will be measured by aggregating the number of patients readmitted to the hospital within 6 months following enrollment based on EHR records and/or patient self-report.
Time frame
From enrollment to the end of the 6 month monitoring period3
Frequency of readmission in the in the early enrollment cohort compared to the late enrollment cohort at equivalent time points post-discharge
Highest risk for recurrent stroke is in the initial 6 months following the first stroke. Frequency of recurrent stroke will be measured by aggregating the number of patients readmitted to the hospital within 6 months following enrollment based on EHR records and/or patient self-report.
Time frame
From enrollment to the end of the 6 month monitoring periodSponsors and contacts
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Source ClinicalTrials.gov