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

NCT04000971 | Completed Results DMC

• 1 other identifier: C3FIT
• Study Type: interventional
• Target: 1,196
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Stroke; Stroke, Ischemic; Stroke, Acute; Stroke Sequelae; Engagement, Patient; Stroke Hemorrhagic

Keywords

Technology-enabled; Engagement, caregiver; Team-based; Integrated Care

Outcome Measures

Primary Outcomes (2)

• Stroke Impact Scale (SIS) at 12-months Post-discharge

  59-item questionnaire to assess aspects of patient quality of life following stroke; includes 8 dimensions assessed on a 5-point Likert scale that are summed by domain. Scores range from 0-100, with higher scores indicating less difficulty.

  12 months post-stroke

• Modified Rankin Scale at 12 Months Post-stroke

  The Modified Rankin Score (mRS) is a widely used scale to measure the degree of disability or dependence in daily activities of individuals who have suffered a stroke. Scores were categorized as 0-2 or \>2. Overview of the Modified Rankin Scale * 0: No symptoms at all * 1: No significant disability; able to carry out all usual activities * 2: Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance * 3: Moderate disability; requiring some help, but able to walk unassisted * 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance * 5: Severe disability; bedridden, incontinent, and requiring constant nursing care * 6: Dead

  12 months post-stroke

Secondary Outcomes (35)

• Stroke Impact Scale (SIS) at 3-months Post-discharge

  3-months post-stroke

• Stroke Impact Scale (SIS) at 6-months Post-discharge

  6-months post-discharge

• Modified Rankin Scale (mRS) at 3-months Post-discharge

  3-months post-stroke

• Modified Rankin Scale (mRS) at 6-months Post-discharge

  6-months post-discharge

• Stroke Risk Factors - Blood Pressure Control (BP) at 3-months Post-discharge

  3-months post-discharge

Study Arms (2)

Integrated Stroke Practice Unit (ISPU)

ACTIVE COMPARATOR

ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.

Other: Integrated Stroke Practice Unit

Comprehensive or Primary Stroke Center (CSC/PSC)

ACTIVE COMPARATOR

CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.

Other: Comprehensive or Primary Stroke Center

Interventions

Integrated Stroke Practice Unit OTHER

Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, and increase understanding and build positive behavior change for patients and caregivers. Primary and secondary outcomes will be assessed at 3, 6, and 12 months.

Also known as: ISPU

Integrated Stroke Practice Unit (ISPU)

Comprehensive or Primary Stroke Center OTHER

Primary and secondary outcomes will be assessed at 3, 6, and 12 months.

Also known as: CSC/PSC

Comprehensive or Primary Stroke Center (CSC/PSC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (21)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Emory University/Grady Health

Atlanta, Georgia, 30303, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Intermountain

Las Vegas, Nevada, 89128, United States

Location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

Ohio Health Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Penn State

State College, Pennsylvania, 16802, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Johnson City Medical Center at Ballad Health

Johnson City, Tennessee, 37604, United States

Location

Covenant Health Fort Sanders Regional Medical Center

Knoxville, Tennessee, 37916, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37322, United States

Location

Doctors Hospital Renaissance

Edinburg, Texas, 78539, United States

Location

University of Wisconsin Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

• Commiskey P, Long DL, Howard VJ, Braunlin J, Howard G, Cochran D, Jackson B, Bell D, Hill D, Callahan AE, Gaines K. Design and methods of a cluster-randomized pragmatic trial of post-discharge stroke care. Contemp Clin Trials. 2025 Jun;153:107890. doi: 10.1016/j.cct.2025.107890. Epub 2025 Apr 4.

  PMID: 40189199 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Patient Participation; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

C3FIT's "active control" group (where patients in the comparator group received (The Joint Commission (TJC)-prescribed treatments proven to substantially improve mortality/functional outcomes) may have made it difficult to show the benefit of ISPU+CSC management. C3FIT also planned to follow patients for 2-years, but coronavirus disease-2019 and other challenges shortened follow-up to only 1-year, which may not have been sufficient for the benefit to be experienced on the primary outcomes.

Results Point of Contact

• Title: Dr. Kenneth Gaines
• Organization: Vanderbilt University Medical Center

k_gaines@msn.com

803-476-2976

Study Officials

• Kenneth Gaines, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Barry Jackson

  PRINCIPAL INVESTIGATOR

• George Howard, DrPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary outcomes will be assessed by telephone at 3, 6, and 12 months by the University of Alabama at Birmingham (UAB)'s Survey Research Unit (SRU). Research staff at the SRU will be masked to treatment arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Neurology; Medical Director, Vanderbilt Teleneurology

Model Details: Pragmatic randomized trial of approximately 22 clinical sites in the United States; randomization is by clinical site.

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 27, 2019
• Study Start: February 25, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 15, 2026
• Results First Posted: May 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)