Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Stroke Care

Completed · Not applicable

Conditions studied: Stroke, Stroke, Ischemic, Stroke, Acute, Stroke Sequelae, Engagement, Patient, Stroke Hemorrhagic

In brief

Stroke is the 5th leading cause of death and the leading cause of adult disability in the United States (US). Stroke is a complex disease with multiple interacting risk factors (including genetic, high blood pressure and cholesterol, and lifestyle factors like smoking, diet, and exercise) that lead to initial and recurrent stroke. Up to 90% of stroke survivors have some functional deficit that impacts both physical and mental health.

Key facts

Study ID

NCT04000971

Run by

Vanderbilt University Medical Center

People needed

1196

Starts

2020-02-25

Expected to finish

2024-09-30

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18+.
• Clinical diagnosis of acute stroke with brain imaging compatible with intracerebral hemorrhage or ischemic stroke (including normal brain scan); see International Classification of Disease 10 (ICD 10) codes.
• English or Spanish speaking subjects.
• Patient admitted within 7 days of their index stroke event.
• Patient is discharged alive and not to hospice care.
• Patient living at discharge within the geography of recruitment for that C3FIT site.
• Pre-morbid Modified Rankin Score (mRS) score of 0-1.
• Patient and/or surrogate give consent to participate after an informed consent process.
• Patients who go to rehabilitation inpatient therapy or other care facilities are eligible, as long as they reside in the geographic are of recruitment and do not go to hospice care.

You may not qualify if…

• Clinical transient ischemic attack (TIA)38-41 is excluded even if there is a computerized tomography (CT) or magnetic resonance imaging (MRI) lesion corresponding to the clinical syndrome at presentation.
• Already enrolled or planned enrollment in another clinical trial for which participation in C3FIT would be compromised with regard to follow-up assessment of outcomes or continuation in C3FIT.
• Patients with a planned admission to hospice care prior to consent.
• Patients not anticipated to survive for 1-year due to neurological or other medical status (i.e., advanced cancer, hospice care, heart disease, etc.).
• Patients who in the opinion of the site investigator cannot be involved in follow up care.
• Inability or unwillingness of subject or legal guardian/representative to understand and cooperate with study procedures or provide informed consent.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Emory University/Grady Health — Atlanta, Georgia, United States
• Augusta University Medical Center — Augusta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Louisville Hospital — Louisville, Kentucky, United States
• Intermountain — Las Vegas, Nevada, United States
• University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States
• Ohio Health Riverside Methodist Hospital — Columbus, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Penn State — State College, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Johnson City Medical Center at Ballad Health — Johnson City, Tennessee, United States
• Covenant Health Fort Sanders Regional Medical Center — Knoxville, Tennessee, United States
• Baptist Memorial Hospital — Memphis, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Doctors Hospital Renaissance — Edinburg, Texas, United States
• University of Wisconsin Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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