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Integrated Stroke Care for Stroke (C3FIT Trial)

N/A
Waitlist Available
Led By Barry Jackson
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pre-morbid mRS Rankin score of 0-1
Pre-morbid mRS Rankin score of 0-1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, and 12 months post-stroke
Awards & highlights

C3FIT Trial Summary

This trial will test a new stroke care design called an Integrated Practice Unit (IPU) to see if it is associated with decreased hospital length of stay, readmissions, and stroke recurrence, as well as lower cost.

Who is the study for?
This trial is for adults who've had a stroke within the last 7 days, can speak English or Spanish, and are not going to hospice care. They must live in the study area and be able to give consent. Those with minor disabilities before their stroke (mRS Rankin score of 0-1) are eligible.Check my eligibility
What is being tested?
The C3FIT trial compares traditional stroke centers with an Integrated Stroke Practice Unit (ISPU). ISPU offers team-based care from emergency through a year post-discharge, including home visits and telehealth support by nurses and health educators.See study design
What are the potential side effects?
Since this trial focuses on service delivery rather than medication, typical drug side effects aren't expected. However, participants may experience varying levels of stress or discomfort due to different care approaches.

C3FIT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had no or minimal disability before my current illness.
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I had no or minimal disability before my current illness.
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I have been diagnosed with a stroke, confirmed by brain scans.
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I have been diagnosed with a stroke and my brain scan shows it.
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I was admitted to the hospital within a week of my stroke.

C3FIT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, and 12 months post-stroke
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, and 12 months post-stroke for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Stroke Impact Scale (SIS 3.0)
Secondary outcome measures
Depression: Patient Health Questionnaire (PHQ-9)
Modified Caregiver Strain Index (mCSI)
Modified Rankin Scale
+12 more

C3FIT Trial Design

2Treatment groups
Active Control
Group I: Integrated Stroke Practice Unit (ISPU)Active Control1 Intervention
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.
Group II: Comprehensive or Primary Stroke Center (CSC/PSC)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
554 Previous Clinical Trials
29,943,552 Total Patients Enrolled
6 Trials studying Stroke
169,923 Patients Enrolled for Stroke
University of Alabama at BirminghamOTHER
1,594 Previous Clinical Trials
2,281,271 Total Patients Enrolled
36 Trials studying Stroke
85,587 Patients Enrolled for Stroke
Vanderbilt University Medical CenterLead Sponsor
865 Previous Clinical Trials
671,350 Total Patients Enrolled
11 Trials studying Stroke
4,598 Patients Enrolled for Stroke

Media Library

Comprehensive or Primary Stroke Center Clinical Trial Eligibility Overview. Trial Name: NCT04000971 — N/A
Stroke Research Study Groups: Integrated Stroke Practice Unit (ISPU), Comprehensive or Primary Stroke Center (CSC/PSC)
Stroke Clinical Trial 2023: Comprehensive or Primary Stroke Center Highlights & Side Effects. Trial Name: NCT04000971 — N/A
Comprehensive or Primary Stroke Center 2023 Treatment Timeline for Medical Study. Trial Name: NCT04000971 — N/A
~86 spots leftby Oct 2024
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