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Completed

NCT Number: NCT04000971

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: ISPU

Comprehensive or Primary Stroke Center

Other

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

Other names: CSC/PSC

Primary outcomes

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

    Time frame: 12 months post-stroke

    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.

  2. Modified Rankin Scale at 12 Months Post-stroke

    Time frame: 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

Secondary outcomes

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

    Time frame: 3-months post-stroke

    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.

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

    Time frame: 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.

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

    Time frame: 3-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
  4. Modified Rankin Scale (mRS) at 6-months Post-discharge

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 3-months post-stroke

    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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 3-months post-stroke

    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).

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

    Time frame: 6-months post-stroke

    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).

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

    Time frame: 12-months post-stroke

    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

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

    Time frame: 3-months post-stroke

    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.

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

    Time frame: 6-months post-stroke

    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.

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

    Time frame: 12-months post-stroke

    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.

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

    Time frame: 3-months post-stroke

    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.

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

    Time frame: 6-months post-stroke

    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.

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

    Time frame: 12-months post-stroke

    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.

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

    Time frame: 3-months post-stroke

    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. .

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

    Time frame: 6-months post-stroke

    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. .

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

    Time frame: 12-months post-stroke

    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. .

  26. Mortality at 12-months Post-discharge

    Time frame: 12-months post-discharge

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

  27. Rehospitalization

    Time frame: 12-months post-stroke

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

  28. Recurrence

    Time frame: 12-months post-stroke

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

  29. Time at Home

    Time frame: 12-months post-stroke

    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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 3-months post-stroke

    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.

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

    Time frame: 6-months post-discharge

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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Patient-Centered Outcomes Research Institute
  • University of Alabama at Birmingham

Registry information

Official study title

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

Acronym: C3FIT

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 27, 2019
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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