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StrokeC3FITNCT04000971

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

A study testing Integrated Stroke Practice Unit and Comprehensive or Primary Stroke Center in people with Stroke and Stroke, Ischemic, run by Vanderbilt University Medical Center at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Stroke, Ischemic, Stroke, Acute
What is being tested?
Integrated Stroke Practice Unit and Comprehensive or Primary Stroke Center
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,196 participants
Where
21 sitesUnited States
Study dates
25 Feb 2020to 30 Sep 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87131

  • Emory University/Grady Health

    Atlanta, Georgia, 30303

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • Ohio Health Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Doctors Hospital Renaissance

    Edinburg, Texas, 78539

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Johnson City Medical Center at Ballad Health

    Johnson City, Tennessee, 37604

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Covenant Health Fort Sanders Regional Medical Center

    Knoxville, Tennessee, 37916

  • Intermountain

    Las Vegas, Nevada, 89128

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

  • University of Wisconsin Madison

    Madison, Wisconsin, 53705

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37322

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Penn State

    State College, Pennsylvania, 16802

Other trials in United States

About this study

Official title: C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Care): A Randomized Trial for Stroke

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.

Read the detailed description

Scientific evidence that identifies the best stroke care delivery design is lacking. We completed a three-year, Centers for Medicare \& Medicaid Services (CMS) Health Care Innovation Award that tested a new stroke care design called an Integrated Practice Unit (IPU). This IPU was developed through stakeholder input from patients, caregivers, nurses, stroke specialists, rehabilitation specialists, patient advocacy groups, payers, and technology companies. This IPU design was associated with decreased hospital length of stay, readmissions, and stroke recurrence, as well as lower cost.

Based on the CMS study, a larger, pragmatic trial was developed that is called C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, and Technology-enabled Stroke Care). C3FIT will randomly assign approximately 22 US hospital sites to continue Joint Commission-certified Comprehensive/Primary (CSC/PSC) design or to the novel Integrated Stroke Practice Unit (ISPU) design for stroke care. C3FIT's ISPU uses team-based, enhanced collaboration (called Stroke Central) and follows patients from presentation at the Emergency Department (ED) through 12-months post-discharge (called Stroke Mobile). Stroke Mobile includes a nurse and lay health educator team who visit patients and caregivers at home or at a rehabilitation or skilled nursing facility to assess function and quality of life using telehealth technology to facilitate access to multiple providers. Results from C3FIT will provide high quality scientific evidence to determine the best stroke care design that ensures positive health for patients and caregivers.

Being tested
Integrated Stroke Practice Unit, Comprehensive or Primary Stroke Center
Keywords
Technology-enabled, Engagement, caregiver, Team-based, Integrated Care
Medical subject headings
Stroke, Ischemic Stroke, Patient Participation, Hemorrhagic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrated Stroke Practice UnitOther

    Also called ISPU

    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.

  • Comprehensive or Primary Stroke CenterOther

    Also called CSC/PSC

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

Study groups in NCT04000971
Study groupRoleWhat they receive
Integrated Stroke Practice Unit (ISPU)Active comparatorISPU 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.
Receives: Other: Integrated Stroke Practice Unit
Comprehensive or Primary Stroke Center (CSC/PSC)Active comparatorCSC/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.
Receives: Other: Comprehensive or Primary Stroke Center

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months post-stroke

  2. 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

    Measured: 12 months post-stroke

Secondary outcomes (35)

  1. Stroke Impact Scale (SIS) at 3-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.

    Measured: 3-months post-stroke

  2. Stroke Impact Scale (SIS) at 6-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.

    Measured: 6-months post-discharge

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

    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

    Measured: 3-months post-stroke

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

    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

    Measured: 6-months post-discharge

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

    To assess BP control through measurement of a seated patient using a blood pressure cuff; controlled BP is 120-130/80 or below for ischemic stroke patients and 140/80 or below for hemorrhagic stroke patients.

    Measured: 3-months post-discharge

  6. Stroke Risk Factors-Blood Pressure (BP) at 6-months Post-discharge

    To assess BP control through measurement of a seated patient using a blood pressure cuff; controlled BP is 120-130/80 or below for ischemic stroke patients and 140/80 or below for hemorrhagic stroke patients.

    Measured: 6-months post-discharge

  7. Stroke Risk Factors-BP at 12-months Post-discharge

    To assess BP control through measurement of a seated patient using a blood pressure cuff; controlled BP is 120-130/80 or below for ischemic stroke patients and 140/80 or below for hemorrhagic stroke patients.

    Measured: 12-months post-discharge

  8. Stroke Risk Factors - Cholesterol (LDL) at 3-months Post-discharge

    To assess LDL/lipids control through a LDL or lipids blood draw (standard of care) for patients with elevated cholesterol at baseline (prior to hospital discharge); controlled LDL is less than/equal to 70 for stroke patients.

    Measured: 3-months post-discharge

  9. Stroke Risk Factors - Cholesterol (LDL) at 6-months Post-discharge

    To assess LDL/lipids control through a LDL or lipids blood draw (standard of care) for patients with elevated cholesterol at baseline (prior to hospital discharge); controlled LDL is less than/equal to 70 for stroke patients.

    Measured: 6-months post-discharge

  10. Stroke Risk Factors - Cholesterol (LDL) at 12-months Post-discharge

    To assess LDL/lipids control through a LDL or lipids blood draw (standard of care) for patients with elevated cholesterol at baseline (prior to hospital discharge); controlled LDL is less than/equal to 70 for stroke patients.

    Measured: 12-months post-discharge

  11. Stroke Risk Factors - Blood Sugar (HgBA1c) at 3-months Post-discharge

    To assess blood sugar control through a HgBA1c blood draw (standard of care) for patients with elevated blood sugar at baseline (prior to hospital discharge); controlled HgBA1c is less than/equal to 7% for stroke patients.

    Measured: 3-months post-stroke

  12. Stroke Risk Factors - Blood Sugar (HgBA1c) at 6-months Post-discharge

    To assess blood sugar control through a HgBA1c blood draw (standard of care) for patients with elevated blood sugar at baseline (prior to hospital discharge); controlled HgBA1c is less than/equal to 7% for stroke patients.

    Measured: 6-months post-discharge

  13. Stroke Risk Factors - Blood Sugar (HgBA1c) at 12-months Post-discharge

    To assess blood sugar control through a HgBA1c blood draw (standard of care) for patients with elevated blood sugar at baseline (prior to hospital discharge); controlled HgBA1c is less than/equal to 7% for stroke patients.

    Measured: 12-months post-discharge

  14. Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 3-months Post-discharge

    To assess weight status by measuring patients' weight and height and applying a formula; patients with normal weight have BMI kg/m*2=18.5-24.9 (BMI less than 18.5 kg/m^2 is underweight, and BMI 25.0 kg/m^2 or above is overweight (BMI=25.0-29.9 kg/m^2 ) or obese (BMI=30.0 kg/m^2 or above).

    Measured: 3-months post-stroke

  15. Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 6-months Post-discharge

    To assess weight status by measuring patients' weight and height and applying a formula; patients with normal weight have BMI kg/m*2=18.5-24.9 (BMI less than 18.5 kg/m^2 is underweight, and BMI 25.0 kg/m^2 or above is overweight (BMI=25.0-29.9 kg/m^2) or obese (BMI=30.0 kg/m2 or above).

    Measured: 6-months post-stroke

  16. Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 12-months Post-discharge

    To assess weight status by measuring patients' weight and height and applying a formula; patients with normal weight have BMI kg/m*2=18.5-24.9 (BMI less than 18.5 kg/m^2 is underweight, and BMI 25.0 kg/m^2 or above is overweight (BMI=25.0-29.9 kg/m^2) or obese (BMI=30.0 kg/m^2 or above). All measures are in kg/m*2

    Measured: 12-months post-stroke

  17. Stroke Risk Factors - Diet at 3-months Post-discharge

    Participants were asked one yes/no question to measure awareness of and adherence to the DASH (Dietary Approaches to Stop Hypertension) eating plan and the Mediterranean Diet. Total number of yes scores is provided where a yes score indicates better adherence to the dietary pattern and therefore in control and a no answer indicated poorer adherence and not in control.

    Measured: 3-months post-stroke

  18. Stroke Risk Factors - Diet at 6-months Post-discharge

    Participants were asked one yes/no question to measure awareness of and adherence to the DASH (Dietary Approaches to Stop Hypertension) eating plan and the Mediterranean Diet. Total number of yes scores is provided where a yes score indicates better adherence to the dietary pattern and therefore in control and a no answer indicated poorer adherence and not in control.

    Measured: 6-months post-stroke

  19. Stroke Risk Factors - Diet at 12-months Post-discharge

    Participants were asked one yes/no question to measure awareness of and adherence to the DASH (Dietary Approaches to Stop Hypertension) eating plan and the Mediterranean Diet. Total number of yes scores is provided where a yes score indicates better adherence to the dietary pattern and therefore in control and a no answer indicated poorer adherence and not in control.

    Measured: 12-months post-stroke

  20. Stroke Risk Factors - Smoking Status/Cessation at 3-months Post-discharge

    Participants who ever smoked were asked one yes/no question "Do you smoke now?" to measure compliance with the smoking cessation recommendation. Total number of participants answering yes indicates adherence to the smoking cessation recommendation pattern and therefore in-control while a no answer indicates non-adherence and not in control.

    Measured: 3-months post-stroke

  21. Stroke Risk Factors - Smoking Status/Cessation at 6-months Post-discharge

    Participants who ever smoked were asked one yes/no question "Do you smoke now?" to measure compliance with the smoking cessation recommendation. Total number of participants answering yes indicates adherence to the smoking cessation recommendation pattern and therefore in-control while a no answer indicates non-adherence and not in control.

    Measured: 6-months post-stroke

  22. Stroke Risk Factors - Smoking Status/Cessation at 12-months Post-discharge

    Participants who ever smoked were asked one yes/no question "Do you smoke now?" to measure compliance with the smoking cessation recommendation. Total number of participants answering yes indicates adherence to the smoking cessation recommendation pattern and therefore in-control while a no answer indicates non-adherence and not in control.

    Measured: 12-months post-stroke

  23. Stroke Risk Factors - Exercise at 3-months Post-discharge

    To assess self-reported adherence to American Stroke Association exercise guidelines (patients with stroke or transient ischemic attack (TIA) who are capable of at least moderate-intensity aerobic activity for a minimum of 10 minutes 4x per week, or vigorous intensity activity for a minimum of 20 minutes 2x per week is indicated) except as modified by the participants physician or physical therapist, Participants were asked one yes/no question to measure awareness of and adherence to the exercise recommendations Total number of participants with a yes score indicates adherence to the exercise recommendation pattern and therefore in-control while a no answer indicates non-adherence to the recommendation and not in control. .

    Measured: 3-months post-stroke

  24. Stroke Risk Factors - Exercise at 6-months Post-discharge

    To assess self-reported adherence to American Stroke Association exercise guidelines (patients with stroke or transient ischemic attack (TIA) who are capable of at least moderate-intensity aerobic activity for a minimum of 10 minutes 4x per week, or vigorous intensity activity for a minimum of 20 minutes 2x per week is indicated) except as modified by the participants physician or physical therapist, Participants were asked one yes/no question to measure awareness of and adherence to the exercise recommendations Total number of participants with a yes score indicates adherence to the exercise recommendation pattern and therefore in-control while a no answer indicates non-adherence to the recommendation and not in control. .

    Measured: 6-months post-stroke

  25. Stroke Risk Factors - Exercise at 12-months Post-discharge

    To assess self-reported adherence to American Stroke Association exercise guidelines (patients with stroke or transient ischemic attack (TIA) who are capable of at least moderate-intensity aerobic activity for a minimum of 10 minutes 4x per week, or vigorous intensity activity for a minimum of 20 minutes 2x per week is indicated) except as modified by the participants physician or physical therapist, Participants were asked one yes/no question to measure awareness of and adherence to the exercise recommendations Total number of participants with a yes score indicates adherence to the exercise recommendation pattern and therefore in-control while a no answer indicates non-adherence to the recommendation and not in control. .

    Measured: 12-months post-stroke

  26. Mortality at 12-months Post-discharge

    Mortality following stroke will be assessed with family member, through study personnel, and/or using public sources.

    Measured: 12-months post-discharge

  27. Rehospitalization

    Rehospitalization following stroke will be assessed/confirmed with study personnel.

    Measured: 12-months post-stroke

  28. Recurrence

    Recurrence of stroke will be assessed/confirmed with study personnel.

    Measured: 12-months post-stroke

  29. Time at Home

    Time spent at home compared to institution assessed/confirmed with study personnel. Time at home is the proportion of time the participant spent at home out of their time at risk in this study (defined as being alive and with known status). The time at home is defined by subtracting time during hospitalization/rehabilitation/skilled nursing from the total time at risk and divided by total time at risk to get the proportion of time at home.

    Measured: 12-months post-stroke

  30. Depression: Patient Health Questionnaire (PHQ-9) at 3-months Post-discharge

    9-item questionnaire to assess presence and/or severity of patient depression (includes an additional question to assess difficulty that doesn't impact scoring); scores range from 0-27, with 0=No depression, 1-4=Minimal depression, 5-9=Mild depression, 10-14=Moderate depression, 15-19=Moderately severe depression; and 20-27=Severe depression.

    Measured: 3-months post-discharge

  31. Depression: Patient Health Questionnaire (PHQ-9) at 6-months Post-discharge

    Depression: Patient Health Questionnaire (PHQ-9) at 3-months post-discharge 9-item questionnaire to assess presence and/or severity of patient depression (includes an additional question to assess difficulty that doesn't impact scoring); scores range from 0-27, with 0=No depression, 1-4=Minimal depression, 5-9=Mild depression, 10-14=Moderate depression, 15-19=Moderately severe depression; and 20-27=Severe depression.

    Measured: 6-months post-discharge

  32. Depression: Patient Health Questionnaire (PHQ-9) at 12-months Post-discharge

    9-item questionnaire to assess presence and/or severity of patient depression (includes an additional question to assess difficulty that doesn't impact scoring); scores range from 0-27, with 0=No depression, 1-4=Minimal depression, 5-9=Mild depression, 10-14=Moderate depression, 15-19=Moderately severe depression; and 20-27=Severe depression.

    Measured: 12-months post-discharge

  33. Modified Caregiver Strain Index (mCSI) at 3-months Post-discharge

    13-item questionnaire to assess the level of strain in caregivers. Scores can range from 0-26, with higher scores indicating increased caregiver strain. Mean scores for each arm are provided and standard deviation of the mean.

    Measured: 3-months post-stroke

  34. Modified Caregiver Strain Index (mCSI) at 6-months Post-discharge

    13-item questionnaire to assess the level of strain in caregivers, with higher scores indicating increased caregiver strain.

    Measured: 6-months post-discharge

  35. Modified Caregiver Strain Index (mCSI) at 12-months Post-discharge

    13-item questionnaire to assess the level of strain in caregivers. Scores can range from 0-26, with higher scores indicating increased caregiver strain. Mean scores for each arm are provided and standard deviation of the mean.

    Measured: 12-months post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2019
  2. Study start25 Feb 2020
  3. Primary completion30 Sep 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pragmatic randomized trial of approximately 22 clinical sites in the United States; randomization is by clinical site.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04000971
Sponsor's protocol ID
C3FIT
Acronym
C3FIT
Status last verified
Apr 2026
First submitted
25 Jun 2019
Last updated
15 May 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40189199

Questions about this trial

What is this clinical trial studying?

A study testing Integrated Stroke Practice Unit and Comprehensive or Primary Stroke Center in people with Stroke and Stroke, Ischemic, run by Vanderbilt University Medical Center at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stroke Impact Scale (SIS) at 12-months Post-discharge (time frame: 12 months post-stroke). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04000971, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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