Clinical trial NCT06657235: Transitional Care Program to Improve Risk Factors in Stroke Survivors
Official title: Improved Risk Factor Control Through a Transitional Care Program for Stroke Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Ischemic
Keywords: transitional care program
secondary stroke prevention
stroke care
Lead sponsor: Syntrillo, Inc
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 224
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Primary outcomes:
measure: Increased compliance with therapeutic standards of care according to the American Heart Association (AHA) guidelines for secondary stroke prevention in early vs late group
timeFrame: From enrollment to the end of the 6 month monitoring period
measure: 90% of systolic blood pressure (SBP) readings < 130 mmHg AND 90% of diastolic blood pressure (DBP) readings < 80 mmHg in a one week period
timeFrame: From enrollment to the end of the 6 month monitoring period
measure: Moderate intensity activity > 150 minutes per week on average
timeFrame: From enrollment to the end of the 6 month monitoring period
measure: Correct prescription of antiplatelet, anticoagulant, and statin medications per guidelines when no contraindications are present
timeFrame: From enrollment to the end of the 6 month monitoring period
measure: Adherence of antiplatelet, anticoagulant, and statin medications > 90%
timeFrame: From enrollment to the end of the 6 month monitoring period
Secondary outcomes:
measure: Average change in compliance percentage at 1, 2, and 3 months following initiation of our transitional care program
timeFrame: From enrollment to the end of the 6 month monitoring period
measure: Frequency of recurrent stroke in the early enrollment cohort compared to the late enrollment cohort at equivalent time points post-discharge
timeFrame: From enrollment to the end of the 6 month monitoring period
measure: Frequency of readmission in the in the early enrollment cohort compared to the late enrollment cohort at equivalent time points post-discharge
timeFrame: From enrollment to the end of the 6 month monitoring period
Other outcomes:
Locations:
city: Winchester
country: United States
facility: Valley Health System
state: Virginia
Study officials:
References: