Transitional Care Program to Improve Risk Factors in Stroke Survivors

Last updated: October 22, 2024
Sponsor: Syntrillo, Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Blood Clots

Thrombosis

Treatment

Transitional Care Program

Clinical Study ID

NCT06657235
2024002
  • Ages > 30
  • All Genders

Study 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

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 strokeunit

  • Enrollment date between 1 and 6 months after discharge for inpatient admission forischemic stroke

Exclusion

Exclusion Criteria:

  • Participants determined to have hemorrhagic or periprocedural stroke based onhospital EMR review will be excluded.

  • Participants determined to have an ischemic stroke due to dissection based onhospital EMR review will be excluded.

  • Participants who lack capacity determined by the care team during theirhospitalization (for the early enrollment group) or their most recent clinicalencounter (for the late enrollment group) will be excluded

  • Participants with a diagnosis of dementia 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 studyincluding: participation is voluntary, the major procedures, the primary risk,and the primary benefit.

  • Participants who are discharged to Long-term Acute Care Hospitals or Skilled NursingFacilities because they are unable to meet the minimum threshold for dailyrehabilitation therapy for an Acute Rehabilitation Facility will be excluded.

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

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

Study Design

Total Participants: 224
Treatment Group(s): 1
Primary Treatment: Transitional Care Program
Phase:
Study Start date:
August 16, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • MaineHealth Maine Medical Center Portland

    Portland, Maine 04102
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23510
    United States

    Site Not Available

  • Valley Health System

    Winchester, Virginia 22601
    United States

    Active - Recruiting

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