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Cuidado del accidente cerebrovascular coordinado, colaborativo, integral, basado en la familia, integrado y habilitado por la tecnología (C3FIT)

23 de abril de 2026 actualizado por: Kenneth Gaines, Vanderbilt University Medical Center

C3FIT (Cuidado coordinado, colaborativo, completo, basado en la familia, integrado y habilitado por la tecnología): un ensayo aleatorizado para el accidente cerebrovascular

El accidente cerebrovascular es la quinta causa principal de muerte y la principal causa de discapacidad en adultos en los Estados Unidos (EE. UU.). El accidente cerebrovascular es una enfermedad compleja con múltiples factores de riesgo que interactúan (incluidos los genéticos, la presión arterial alta y el colesterol, y los factores del estilo de vida como fumar, la dieta y el ejercicio) que conducen al accidente cerebrovascular inicial y recurrente. Hasta el 90 % de los supervivientes de un accidente cerebrovascular tienen algún déficit funcional que afecta tanto a la salud física como mental.

Faltan pruebas científicas que identifiquen el mejor diseño de atención del accidente cerebrovascular. Completamos un Premio a la Innovación en el Cuidado de la Salud de los Centros de Servicios de Medicare y Medicaid (CMS) de tres años que probó un nuevo diseño de atención de accidentes cerebrovasculares llamado Unidad de Práctica Integrada (IPU). Esta IPU se desarrolló a través de los aportes de las partes interesadas de pacientes, cuidadores, enfermeras, especialistas en accidentes cerebrovasculares, especialistas en rehabilitación, grupos de defensa de pacientes, pagadores y empresas de tecnología. Este diseño de UIP se asoció con una menor duración de la estancia hospitalaria, reingresos y recurrencia del accidente cerebrovascular, así como con un menor costo.

Con base en el estudio de CMS, se desarrolló un ensayo pragmático más grande llamado C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, and Technology-enabled Stroke Care). C3FIT asignará aleatoriamente 18 sitios hospitalarios de EE. UU. para continuar con el diseño Integral/Primario certificado por la Comisión Conjunta (CSC/PSC) o con el novedoso diseño de la Unidad de Práctica Integrada de Accidentes Cerebrovasculares (ISPU) para la atención de accidentes cerebrovasculares. La ISPU de C3FIT utiliza una colaboración mejorada basada en equipos (llamada Stroke Central) y sigue a los pacientes desde la presentación en el Departamento de Emergencias (ED) hasta los 12 meses posteriores al alta (llamada Stroke Mobile). Stroke Mobile incluye un equipo de enfermeras y educadores de salud legos que visitan a los pacientes y cuidadores en el hogar o en un centro de rehabilitación o de enfermería especializada para evaluar la función y la calidad de vida utilizando tecnología de telesalud para facilitar el acceso a múltiples proveedores. Los resultados de C3FIT proporcionarán evidencia científica de alta calidad para determinar el mejor diseño de atención del accidente cerebrovascular que garantice una salud positiva para los pacientes y los cuidadores.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

1196

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85054
        • Mayo Clinic Hospital
    • Connecticut
      • Hartford, Connecticut, Estados Unidos, 06102
        • Hartford Hospital
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32224
        • Mayo Clinic
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30303
        • Emory University/Grady Health
      • Augusta, Georgia, Estados Unidos, 30912
        • Augusta University Medical Center
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Northwestern University
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40202
        • University of Louisville Hospital
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89128
        • Intermountain
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87131
        • University of New Mexico Health Sciences Center
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43214
        • Ohio Health Riverside Methodist Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • University of Pittsburgh Medical Center
      • State College, Pennsylvania, Estados Unidos, 16802
        • Penn State
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Medical University of South Carolina
    • Tennessee
      • Johnson City, Tennessee, Estados Unidos, 37604
        • Johnson City Medical Center at Ballad Health
      • Knoxville, Tennessee, Estados Unidos, 37916
        • Covenant Health Fort Sanders Regional Medical Center
      • Memphis, Tennessee, Estados Unidos, 38120
        • Baptist Memorial Hospital
      • Nashville, Tennessee, Estados Unidos, 37322
        • Vanderbilt University Medical Center
    • Texas
      • Edinburg, Texas, Estados Unidos, 78539
        • Doctors Hospital Renaissance
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53705
        • University of Wisconsin Madison

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Mayores de 18 años.
  • Diagnóstico clínico de accidente cerebrovascular agudo con imágenes cerebrales compatibles con hemorragia intracerebral o accidente cerebrovascular isquémico (incluido el escáner cerebral normal); consulte los códigos ICD 10 en la Tabla 4.
  • Materias de habla inglesa o española.
  • Paciente ingresado dentro de los 7 días de su evento de accidente cerebrovascular índice.
  • El paciente es dado de alta vivo y no para cuidados paliativos.
  • Paciente que vive en el momento del alta dentro de la geografía de reclutamiento para ese sitio C3FIT.
  • Puntuación de Rankin mRS premórbida de 0-1.
  • El paciente y/o el sustituto dan su consentimiento para participar después de un proceso de consentimiento informado.
  • Los pacientes que van a terapia de rehabilitación para pacientes hospitalizados u otros centros de atención son elegibles, siempre que residan en el área geográfica de contratación y no vayan a cuidados paliativos.

Criterio de exclusión:

  • El accidente isquémico transitorio (AIT) clínico38-41 se excluye incluso si existe una lesión en la tomografía computarizada (TC) o en la resonancia magnética (RM) correspondiente al síndrome clínico en el momento de la presentación.
  • Inscripción ya inscrita o planeada en otro ensayo clínico para el cual la participación en C3FIT se vería comprometida con respecto a la evaluación de seguimiento de los resultados o la continuación en C3FIT.
  • Pacientes con una admisión planificada a cuidados paliativos antes del consentimiento.
  • Pacientes que no se prevé que sobrevivan durante 1 año debido a un estado neurológico u otro estado médico (es decir, cáncer avanzado, cuidados paliativos, enfermedad cardíaca, etc.).
  • Pacientes que, en opinión del investigador del sitio, no pueden participar en la atención de seguimiento.
  • Incapacidad o falta de voluntad del sujeto o tutor/representante legal para comprender y cooperar con los procedimientos del estudio o dar su consentimiento informado.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Unidad integrada de práctica de accidentes cerebrovasculares (ISPU)
El personal de ISPU continuará con la atención brindada bajo el diseño CSC/PSC certificado por la Comisión Conjunta, incluida una visita a la clínica de 30 días después del alta. Esto se complementará con un modelo más integrado diseñado para aumentar la coordinación a través de iniciativas basadas en equipos a lo largo de la continuidad de la atención del accidente cerebrovascular, desde la atención aguda y en el hospital hasta los 12 meses posteriores al alta. Los equipos de atención seguirán a los pacientes en su hogar o centro de rehabilitación/enfermería especializada mensualmente durante 12 visitas para evaluar la recuperación, controlar los factores de riesgo, aumentar la comprensión y generar un cambio de comportamiento positivo para los pacientes y cuidadores. Los resultados primarios se evaluarán por teléfono a los 3, 6 y 12 meses; los resultados secundarios se evaluarán a los 3, 6 y 12 meses.
Otro: Unidad de Práctica Integrada de Ictus
Los equipos de atención seguirán a los pacientes en su hogar o centro de rehabilitación/enfermería especializada mensualmente durante 12 visitas para evaluar la recuperación, controlar los factores de riesgo y aumentar la comprensión y generar un cambio de comportamiento positivo para los pacientes y cuidadores. Los resultados primarios y secundarios se evaluarán a los 3, 6 y 12 meses.
Otros nombres:
  • ISPU
Comparador activo: Centro Integral o Primario de Accidentes Cerebrovasculares (CSC/PSC)
El personal de CSC/PSC continuará con la atención brindada bajo el diseño de CSC/PSC certificado por la Comisión Conjunta, incluida una visita a la clínica de 30 días después del alta, visitas a la clínica de seguimiento según lo recomendado por su proveedor ambulatorio y otras visitas a la clínica iniciadas por el paciente cuando surgen problemas. Los resultados primarios se evaluarán por teléfono a los 3, 6 y 12 meses; los resultados secundarios se evaluarán a los 3, 6 y 12 meses.
Otro: Centro integral o primario de accidentes cerebrovasculares
Los resultados primarios y secundarios se evaluarán a los 3, 6 y 12 meses.
Otros nombres:
  • CSC/PSC

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Stroke Impact Scale (SIS) at 12-months Post-discharge
Periodo de tiempo: 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.
12 months post-stroke
Modified Rankin Scale at 12 Months Post-stroke
Periodo de tiempo: 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
12 months post-stroke

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Stroke Impact Scale (SIS) at 3-months Post-discharge
Periodo de tiempo: 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.
3-months post-stroke
Stroke Impact Scale (SIS) at 6-months Post-discharge
Periodo de tiempo: 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.
6-months post-discharge
Modified Rankin Scale (mRS) at 3-months Post-discharge
Periodo de tiempo: 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
3-months post-stroke
Modified Rankin Scale (mRS) at 6-months Post-discharge
Periodo de tiempo: 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
6-months post-discharge
Stroke Risk Factors - Blood Pressure Control (BP) at 3-months Post-discharge
Periodo de tiempo: 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.
3-months post-discharge
Stroke Risk Factors-Blood Pressure (BP) at 6-months Post-discharge
Periodo de tiempo: 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.
6-months post-discharge
Stroke Risk Factors-BP at 12-months Post-discharge
Periodo de tiempo: 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.
12-months post-discharge
Stroke Risk Factors - Cholesterol (LDL) at 3-months Post-discharge
Periodo de tiempo: 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.
3-months post-discharge
Stroke Risk Factors - Cholesterol (LDL) at 6-months Post-discharge
Periodo de tiempo: 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.
6-months post-discharge
Stroke Risk Factors - Cholesterol (LDL) at 12-months Post-discharge
Periodo de tiempo: 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.
12-months post-discharge
Stroke Risk Factors - Blood Sugar (HgBA1c) at 3-months Post-discharge
Periodo de tiempo: 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.
3-months post-stroke
Stroke Risk Factors - Blood Sugar (HgBA1c) at 6-months Post-discharge
Periodo de tiempo: 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.
6-months post-discharge
Stroke Risk Factors - Blood Sugar (HgBA1c) at 12-months Post-discharge
Periodo de tiempo: 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.
12-months post-discharge
Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 3-months Post-discharge
Periodo de tiempo: 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).
3-months post-stroke
Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 6-months Post-discharge
Periodo de tiempo: 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).
6-months post-stroke
Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 12-months Post-discharge
Periodo de tiempo: 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
12-months post-stroke
Stroke Risk Factors - Diet at 3-months Post-discharge
Periodo de tiempo: 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.
3-months post-stroke
Stroke Risk Factors - Diet at 6-months Post-discharge
Periodo de tiempo: 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.
6-months post-stroke
Stroke Risk Factors - Diet at 12-months Post-discharge
Periodo de tiempo: 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.
12-months post-stroke
Stroke Risk Factors - Smoking Status/Cessation at 3-months Post-discharge
Periodo de tiempo: 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.
3-months post-stroke
Stroke Risk Factors - Smoking Status/Cessation at 6-months Post-discharge
Periodo de tiempo: 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.
6-months post-stroke
Stroke Risk Factors - Smoking Status/Cessation at 12-months Post-discharge
Periodo de tiempo: 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.
12-months post-stroke
Stroke Risk Factors - Exercise at 3-months Post-discharge
Periodo de tiempo: 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. .
3-months post-stroke
Stroke Risk Factors - Exercise at 6-months Post-discharge
Periodo de tiempo: 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. .
6-months post-stroke
Stroke Risk Factors - Exercise at 12-months Post-discharge
Periodo de tiempo: 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. .
12-months post-stroke
Mortality at 12-months Post-discharge
Periodo de tiempo: 12-months post-discharge
Mortality following stroke will be assessed with family member, through study personnel, and/or using public sources.
12-months post-discharge
Rehospitalization
Periodo de tiempo: 12-months post-stroke
Rehospitalization following stroke will be assessed/confirmed with study personnel.
12-months post-stroke
Recurrence
Periodo de tiempo: 12-months post-stroke
Recurrence of stroke will be assessed/confirmed with study personnel.
12-months post-stroke
Time at Home
Periodo de tiempo: 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.
12-months post-stroke
Depression: Patient Health Questionnaire (PHQ-9) at 3-months Post-discharge
Periodo de tiempo: 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.
3-months post-discharge
Depression: Patient Health Questionnaire (PHQ-9) at 6-months Post-discharge
Periodo de tiempo: 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.
6-months post-discharge
Depression: Patient Health Questionnaire (PHQ-9) at 12-months Post-discharge
Periodo de tiempo: 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.
12-months post-discharge
Modified Caregiver Strain Index (mCSI) at 3-months Post-discharge
Periodo de tiempo: 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.
3-months post-stroke
Modified Caregiver Strain Index (mCSI) at 6-months Post-discharge
Periodo de tiempo: 6-months post-discharge
13-item questionnaire to assess the level of strain in caregivers, with higher scores indicating increased caregiver strain.
6-months post-discharge
Modified Caregiver Strain Index (mCSI) at 12-months Post-discharge
Periodo de tiempo: 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.
12-months post-discharge

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Vanderbilt University Medical Center

Colaboradores

Patient-Centered Outcomes Research Institute
University of Alabama at Birmingham

Investigadores

  • Investigador principal: Kenneth Gaines, MD, Vanderbilt University Medical Center
  • Investigador principal: Barry Jackson
  • Investigador principal: George Howard, DrPH, University of Alabama at Birmingham

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

25 de febrero de 2020

Finalización primaria (Actual)

30 de septiembre de 2024

Finalización del estudio (Actual)

30 de septiembre de 2024

Fechas de registro del estudio

Enviado por primera vez

25 de junio de 2019

Primero enviado que cumplió con los criterios de control de calidad

26 de junio de 2019

Publicado por primera vez (Actual)

27 de junio de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

23 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • C3FIT

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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