Transitional Care Program to Improve Risk Factors in Stroke Survivors

Syntrillo, Inc

Status: Enrolling

Conditions: Stroke, Ischemic

Treatments: Other: Transitional Care Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06657235

2024002

Details and patient eligibility

About

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

Enrollment: 224 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All Cohorts:

• Age 30 or above
• Evidence of ischemic stroke documented on CT or MRI
• Modified Rankin score of 3 or less

Early Enrollment:

• Admission for ischemic stroke at a participating site
• Enrolled during their admission for ischemic stroke or within 24 hours of discharge

Late Enrollment:

• Stroke survivors previously admitted at the participating sites' inpatient stroke unit
• Enrollment date between 1 and 6 months after discharge for inpatient admission for ischemic stroke

Exclusion criteria

• 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.

• Participants with acute subdural hemorrhage will be excluded.

• Participants with hemorrhagic stroke due to vascular abnormality (aneurysm or AVM) or trauma will be excluded.

• Participants who cannot perform the following will be excluded:

  1. offer a consistent choice about participating in the study
  2. demonstrate that they can comprehend and recall major features of the study including: participation is voluntary, the major procedures, the primary risk, and the primary benefit.

• Participants who are discharged to Long-term Acute Care Hospitals will be excluded.

• Participants who are unable to read or communicate fluently in English will be excluded.

• Participants who do not have reliable internet access to complete telemedicine visits per self-report will be excluded.

• Participants already enrolled in another clinical study which could impact the frequency of monitoring or care that participant receives.

• Participants who do not reside in Virginia, West Virginia, Tennessee, Oklahoma, Illinois, or Michigan will be excluded.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

Early Enrollment

Experimental group

Description:

Participants enrolled around the time of discharge from the hospital immediately following an ischemic stroke.

Treatment:

Other: Transitional Care Program

Late Enrollment

Experimental group

Description:

Participants enrolled mainly between 3-5 months after their discharge from the hospital following an ischemic stroke.

Treatment:

Other: Transitional Care Program