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Trial record 1 of 1 for:    stroke | c3fit
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Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Stroke Care (C3FIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04000971
Recruitment Status : Enrolling by invitation
First Posted : June 27, 2019
Last Update Posted : May 10, 2022
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
University of Alabama at Birmingham
Information provided by (Responsible Party):
Kenneth Gaines, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE June 25, 2019
First Posted Date  ICMJE June 27, 2019
Last Update Posted Date May 10, 2022
Actual Study Start Date  ICMJE February 25, 2020
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Stroke Impact Scale (SIS 3.0) [ 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.
  • Modified Rankin Scale [ Time Frame: 12 months post-stroke ]
    7-item scale to assess the degree of disability/dependence in the daily activities of stroke patients; scores range from 0-5, with higher score indicating higher disability (a score of 6 indicates that the patient expired).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2022)
  • Stroke Impact Scale 3.0 [ Time Frame: 3 and 6 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.
  • Modified Rankin Scale [ Time Frame: 3 and 6 months post-stroke ]
    7-item scale to assess the degree of disability/dependence in the daily activities of stroke patients; scores range from 0-5, with higher score indicating higher disability (a score of 6 indicates that the patient expired).
  • Stroke Risk Factors - Blood Pressure Control (BP) [ Time Frame: 3, 6, and 12 months post-stroke ]
    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.
  • Stroke Risk Factors - Cholesterol (LDL) [ Time Frame: 3, 6, and 12 months post-stroke ]
    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.
  • Stroke Risk Factors - Blood Sugar (HgBA1c) [ Time Frame: 3, 6, and 12 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.
  • Stroke Risk Factors - Body Mass Index (BMI) [ Time Frame: 3, 6, and 12 months post-stroke ]
    To assess weight status by measuring patients' weight and height and applying a formula; patients with normal weight have BMI=18.5-24.9 (BMI less than 18.5 is underweight, and BMI 25.0 or above is overweight (BMI=25.0-29.9) or obese (BMI=30.0 or above).
  • Stroke Risk Factors - Smoking Status/Cessation [ Time Frame: 3, 6, and 12 months post-stroke ]
    To assess smoking status and cessation efforts through self-reported, yes or no questions.
  • Stroke Risk Factors - Diet [ Time Frame: 3, 6, and 12 months post-stroke ]
    To assess awareness of the DASH or Mediterranean diet through self-reported, yes or no questions.
  • Stroke Risk Factors - Exercise [ Time Frame: 3, 6, and 12 months post-stroke ]
    To assess adherence to exercise guidelines that physician or physical therapist advised through self-reported, yes or no questions.
  • Mortality [ Time Frame: 3, 6, and 12 months post-stroke ]
    Mortality following stroke will be assessed with family member, through study personnel, and/or using public sources.
  • Recurrence [ Time Frame: 3, 6, and 12 months post-stroke ]
    Recurrence of stroke will be assessed/confirmed with study personnel.
  • Rehospitalization [ Time Frame: 3, 6, and 12 months post-stroke ]
    Rehospitalization following stroke will be assessed/confirmed with study personnel.
  • Time at Home [ Time Frame: 3, 6, and 12 months post-stroke ]
    Time spent at home compared to institution will be assessed/confirmed with study personnel.
  • Depression: Patient Health Questionnaire (PHQ-9) [ Time Frame: 3, 6, and 12 months post-stroke ]
    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.
  • Modified Caregiver Strain Index (mCSI) [ Time Frame: 3, 6, and 12 months post-stroke ]
    13-item questionnaire to assess the level of strain in caregivers; scores range from 0-100, with higher score indicating increased caregiver strain.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Stroke Impact Scale 3.0 [ Time Frame: 3 and 6 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.
  • Modified Rankin Scale [ Time Frame: 3 and 6 months post-stroke ]
    7-item scale to assess the degree of disability/dependence in the daily activities of stroke patients; scores range from 0-5, with higher score indicating higher disability (a score of 6 indicates that the patient expired).
  • Stroke Impact Scale 3.0 [ Time Frame: 24 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.
  • Modified Rankin Scale [ Time Frame: 24 months post-stroke ]
    7-item scale to assess the degree of disability/dependence in the daily activities of stroke patients; scores range from 0-5, with higher score indicating higher disability (a score of 6 indicates that the patient expired).
  • Stroke Risk Factors - Blood Pressure Control (BP) [ Time Frame: 3, 6, and 12 months post-stroke ]
    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.
  • Stroke Risk Factors - Cholesterol (LDL) [ Time Frame: 3, 6, and 12 months post-stroke ]
    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.
  • Stroke Risk Factors - Blood Sugar (HgBA1c) [ Time Frame: 3, 6, and 12 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.
  • Stroke Risk Factors - Body Mass Index (BMI) [ Time Frame: 3, 6, and 12 months post-stroke ]
    To assess weight status by measuring patients' weight and height and applying a formula; patients with normal weight have BMI=18.5-24.9 (BMI less than 18.5 is underweight, and BMI 25.0 or above is overweight (BMI=25.0-29.9) or obese (BMI=30.0 or above).
  • Stroke Risk Factors - Smoking Status/Cessation [ Time Frame: 3, 6, and 12 months post-stroke ]
    To assess smoking status and cessation efforts through self-reported, yes or no questions.
  • Stroke Risk Factors - Diet [ Time Frame: 3, 6, and 12 months post-stroke ]
    To assess awareness of the DASH or Mediterranean diet through self-reported, yes or no questions.
  • Stroke Risk Factors - Exercise [ Time Frame: 3, 6, and 12 months post-stroke ]
    To assess adherence to exercise guidelines that physician or physical therapist advised through self-reported, yes or no questions.
  • Mortality [ Time Frame: 3, 6, and 12 months post-stroke ]
    Mortality following stroke will be assessed with family member, through study personnel, and/or using public sources.
  • Recurrence [ Time Frame: 3, 6, and 12 months post-stroke ]
    Recurrence of stroke will be assessed/confirmed with study personnel.
  • Rehospitalization [ Time Frame: 3, 6, and 12 months post-stroke ]
    Rehospitalization following stroke will be assessed/confirmed with study personnel.
  • Time at Home [ Time Frame: 3, 6, and 12 months post-stroke ]
    Time spent at home compared to institution will be assessed/confirmed with study personnel.
  • Depression: Patient Health Questionnaire (PHQ-9) [ Time Frame: 3, 6, and 12 months post-stroke ]
    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.
  • Modified Caregiver Strain Index (mCSI) [ Time Frame: 3, 6, and 12 months post-stroke ]
    13-item questionnaire to assess the level of strain in caregivers; scores range from 0-100, with higher score indicating increased caregiver strain.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Stroke Care
Official Title  ICMJE C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Care): A Randomized Trial for Stroke
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.

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 18 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Pragmatic randomized trial of 18 clinical sites in the United States; randomization is by clinical site.
Masking: Single (Outcomes Assessor)
Masking Description:
Primary outcomes will be assessed by telephone at 3, 6, 12, and 24 months by C3FIT's Statistical and Data Coordinating Center (SDCC) Survey Research Unit (SRU) at the University of Alabama Birmingham (UAB). Research staff at the SRU will be masked to treatment arm.
Primary Purpose: Health Services Research
Condition  ICMJE
  • Stroke
  • Stroke, Ischemic
  • Stroke, Acute
  • Stroke Sequelae
  • Engagement, Patient
  • Stroke Hemorrhagic
Intervention  ICMJE
  • Other: Integrated Stroke Practice Unit
    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 and by phone at 24 months.
    Other Name: ISPU
  • Other: Comprehensive or Primary Stroke Center
    Primary and secondary outcomes will be assessed at 3,6,and 12 months and by phone at 24 months.
    Other Name: CSC/PSC
Study Arms  ICMJE
  • Active Comparator: Integrated Stroke Practice Unit (ISPU)
    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, 12, and 24 months; secondary outcomes will be assessed at 3, 6, and 12 months.
    Intervention: Other: Integrated Stroke Practice Unit
  • Active Comparator: Comprehensive or Primary Stroke Center (CSC/PSC)
    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, 12, and 24 months; secondary outcomes will be assessed at 3, 6, and 12 months.
    Intervention: Other: Comprehensive or Primary Stroke Center
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 26, 2019)
1800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2023
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18+.
  • Clinical diagnosis of acute stroke with brain imaging compatible with intracerebral hemorrhage or ischemic stroke (including normal brain scan); see ICD 10 codes in Table 4.
  • 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 mRS Rankin 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04000971
Other Study ID Numbers  ICMJE C3FIT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Kenneth Gaines, Vanderbilt University Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vanderbilt University Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Patient-Centered Outcomes Research Institute
  • University of Alabama at Birmingham
Investigators  ICMJE
Principal Investigator: Kenneth Gaines, MD Vanderbilt University Medical Center
Principal Investigator: Barry Jackson
Principal Investigator: George Howard, DrPH University of Alabama at Birmingham
PRS Account Vanderbilt University Medical Center
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP