N/A
N=1,196
Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Stroke Care
Stroke · Stroke, Ischemic · Stroke, Acute · Stroke Sequelae · Engagement, Patient
Bottom Line
View on ClinicalTrials.gov: NCT04000971 ↗Enrolled (actual)
1,196
Serious AEs
28.3%
Results posted
May 2026
Primary outcome: Primary: Stroke Impact Scale (SIS) at 12-months Post-discharge — 80.42; 83.85 Score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Integrated Stroke Practice Unit (Other); Comprehensive or Primary Stroke Center (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stroke Impact Scale (SIS) at 12-months Post-discharge |
80.42; 83.85 | — |
| PRIMARY Modified Rankin Scale at 12 Months Post-stroke |
214; 255; 134; 107 | — |
| SECONDARY Stroke Impact Scale (SIS) at 3-months Post-discharge |
78.88; 80.97 | — |
| SECONDARY Stroke Impact Scale (SIS) at 6-months Post-discharge |
80.15; 81.39 | — |
| SECONDARY Modified Rankin Scale (mRS) at 3-months Post-discharge |
227; 239; 143; 100 | — |
| SECONDARY Modified Rankin Scale (mRS) at 6-months Post-discharge |
208; 219; 134; 104 | — |
| SECONDARY Stroke Risk Factors - Blood Pressure Control (BP) at 3-months Post-discharge |
200; 164; 156; 210 | — |
| SECONDARY Stroke Risk Factors-Blood Pressure (BP) at 6-months Post-discharge |
184; 152; 133; 178 | — |
| SECONDARY Stroke Risk Factors-BP at 12-months Post-discharge |
195; 147; 121; 187 | — |
| SECONDARY Stroke Risk Factors - Cholesterol (LDL) at 3-months Post-discharge |
113; 61; 82; 56 | — |
| SECONDARY Stroke Risk Factors - Cholesterol (LDL) at 6-months Post-discharge |
63; 32; 69; 45 | — |
| SECONDARY Stroke Risk Factors - Cholesterol (LDL) at 12-months Post-discharge |
81; 40; 61; 56 | — |
| SECONDARY Stroke Risk Factors - Blood Sugar (HgBA1c) at 3-months Post-discharge |
96; 40; 40; 27 | — |
| SECONDARY Stroke Risk Factors - Blood Sugar (HgBA1c) at 6-months Post-discharge |
66; 34; 27; 25 | — |
| SECONDARY Stroke Risk Factors - Blood Sugar (HgBA1c) at 12-months Post-discharge |
75; 39; 34; 32 | — |
| SECONDARY Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 3-months Post-discharge |
28.75; 29.66 | — |
| SECONDARY Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 6-months Post-discharge |
28.50; 29.24 | — |
| SECONDARY Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 12-months Post-discharge |
28.76; 29.06 | — |
| SECONDARY Stroke Risk Factors - Diet at 3-months Post-discharge |
164; 128; 207; 217 | — |
| SECONDARY Stroke Risk Factors - Diet at 6-months Post-discharge |
129; 96; 197; 222 | — |
| SECONDARY Stroke Risk Factors - Diet at 12-months Post-discharge |
141; 109; 187; 240 | — |
| SECONDARY Stroke Risk Factors - Smoking Status/Cessation at 3-months Post-discharge |
30; 40; 343; 310 | — |
| SECONDARY Stroke Risk Factors - Smoking Status/Cessation at 6-months Post-discharge |
28; 35; 299; 283 | — |
| SECONDARY Stroke Risk Factors - Smoking Status/Cessation at 12-months Post-discharge |
22; 39; 309; 310 | — |
| SECONDARY Stroke Risk Factors - Exercise at 3-months Post-discharge |
133; 156; 239; 191 | — |
| SECONDARY Stroke Risk Factors - Exercise at 6-months Post-discharge |
126; 119; 200; 199 | — |
| SECONDARY Stroke Risk Factors - Exercise at 12-months Post-discharge |
152; 155; 178; 194 | — |
| SECONDARY Mortality at 12-months Post-discharge |
39; 30; 577; 550 | — |
| SECONDARY Rehospitalization |
175; 162; 439; 418 | — |
| SECONDARY Recurrence |
39; 32; 575; 548 | — |
| SECONDARY Time at Home |
0.84; 0.92 | — |
| SECONDARY Depression: Patient Health Questionnaire (PHQ-9) at 3-months Post-discharge |
3.66; 4.45 | — |
| SECONDARY Depression: Patient Health Questionnaire (PHQ-9) at 6-months Post-discharge |
3.21; 3.88 | — |
| SECONDARY Depression: Patient Health Questionnaire (PHQ-9) at 12-months Post-discharge |
2.58; 3.60 | — |
| SECONDARY Modified Caregiver Strain Index (mCSI) at 3-months Post-discharge |
5.39; 5.38 | — |
| SECONDARY Modified Caregiver Strain Index (mCSI) at 6-months Post-discharge |
5.20; 4.60 | — |
| SECONDARY Modified Caregiver Strain Index (mCSI) at 12-months Post-discharge |
6.12; 4.15 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04000971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.