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Samordnad, Samverkande, Omfattande, Familjebaserad, Integrerad, Teknikaktiverad Stroke Care (C3FIT)

23 april 2026 uppdaterad av: Kenneth Gaines, Vanderbilt University Medical Center

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

Stroke är den femte vanligaste dödsorsaken och den vanligaste orsaken till funktionshinder för vuxna i USA (USA). Stroke är en komplex sjukdom med flera interagerande riskfaktorer (inklusive genetiska, högt blodtryck och kolesterol, och livsstilsfaktorer som rökning, diet och träning) som leder till initial och återkommande stroke. Upp till 90 % av de som överlever stroke har något funktionellt underskott som påverkar både fysisk och mental hälsa.

Vetenskapliga bevis som identifierar den bästa designen för strokevård saknas. Vi genomförde en treårig, Centers for Medicare & Medicaid Services (CMS) Health Care Innovation Award som testade en ny design för strokevård som kallas en Integrated Practice Unit (IPU). Denna IPU utvecklades genom input från intressenter från patienter, vårdgivare, sjuksköterskor, strokespecialister, rehabiliteringsspecialister, patientgrupper, betalare och teknikföretag. Denna IPU-design var associerad med minskad sjukhusvistelse, återinläggningar och återfall i stroke, samt lägre kostnad.

Baserat på CMS-studien utvecklades en större, pragmatisk studie som kallas C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, and Technology-enabled Stroke Care). C3FIT kommer slumpmässigt att tilldela 18 amerikanska sjukhusplatser för att fortsätta Joint Commission-certifierad Comprehensive/Primary (CSC/PSC) design eller till den nya designen Integrated Stroke Practice Unit (ISPU) för strokevård. C3FIT:s ISPU använder teambaserat, utökat samarbete (kallat Stroke Central) och följer patienter från presentation på akutmottagningen (ED) till 12 månader efter utskrivning (kallad Stroke Mobile). Stroke Mobile inkluderar en sjuksköterska och lekmannahälsopedagogteam som besöker patienter och vårdgivare i hemmet eller på en rehabiliteringsinrättning eller en skicklig sjuksköterskeinrättning för att bedöma funktion och livskvalitet med hjälp av telehälsoteknik för att underlätta tillgången till flera leverantörer. Resultat från C3FIT kommer att ge högkvalitativa vetenskapliga bevis för att fastställa den bästa designen för strokevård som säkerställer positiv hälsa för patienter och vårdgivare.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

1196

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

  • Ålder 18+.
  • Klinisk diagnos av akut stroke med hjärnavbildning som är kompatibel med intracerebral blödning eller ischemisk stroke (inklusive normal hjärnskanning); se ICD 10-koder i Tabell 4.
  • Engelska eller spansktalande ämnen.
  • Patient inlagd inom 7 dagar efter sin index stroke-händelse.
  • Patienten skrivs ut levande och inte till hospice.
  • Patient som lever vid utskrivning inom rekryteringsgeografin för den C3FIT-platsen.
  • Pre-morbid mRS Rankin-poäng på 0-1.
  • Patient och/eller surrogat ger sitt samtycke till att delta efter en process med informerat samtycke.
  • Patienter som går till slutenvårdsterapi för rehabilitering eller andra vårdinrättningar är berättigade, så länge de bor i det geografiska området är av rekrytering och inte går till hospice.

Exklusions kriterier:

  • Klinisk transient ischemisk attack (TIA)38-41 är utesluten även om det finns en datoriserad tomografi (CT) eller magnetisk resonanstomografi (MRT) lesion som motsvarar det kliniska syndromet vid uppkomsten.
  • Redan inskriven eller planerad inskrivning i en annan klinisk prövning för vilken deltagande i C3FIT skulle äventyras med avseende på uppföljande bedömning av utfall eller fortsättning i C3FIT.
  • Patienter med planerad inläggning på hospice innan samtycke.
  • Patienter som inte förväntas överleva i 1 år på grund av neurologisk eller annan medicinsk status (d.v.s. avancerad cancer, hospice, hjärtsjukdom, etc.).
  • Patienter som enligt platsutredaren inte kan involveras i uppföljningsvården.
  • Oförmåga eller ovilja hos försökspersonen eller vårdnadshavare/representant att förstå och samarbeta med studieprocedurer eller ge informerat samtycke.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Integrated Stroke Practice Unit (ISPU)
ISPU-personal kommer att fortsätta med vården som tillhandahålls under den gemensamma kommissionens certifierade CSC/PSC-designen, inklusive ett 30-dagars klinikbesök efter utskrivning. Detta kommer att kompletteras med en mer integrerad modell utformad för att öka samordningen genom teambaserade initiativ över kontinuumet av vården för stroke - från akut och sjukhusvård till 12 månader efter utskrivning. Vårdteam kommer att följa patienter i deras hem eller rehabilitering/utbildad vårdavdelning varje månad under 12 besök för att bedöma tillfrisknande, hantera riskfaktorer, öka förståelsen och skapa positiv beteendeförändring för patienter och vårdgivare. Primära resultat kommer att bedömas per telefon vid 3, 6 och 12 månader; sekundära resultat kommer att bedömas efter 3, 6 och 12 månader.
Övrig: Integrerad Stroke Practice Unit
Vårdteam kommer att följa patienter i deras hem eller rehabilitering/utbildad vårdavdelning varje månad under 12 besök för att bedöma tillfrisknande, hantera riskfaktorer och öka förståelsen och skapa positiv beteendeförändring för patienter och vårdgivare. Primära och sekundära resultat kommer att bedömas efter 3, 6 och 12 månader.
Andra namn:
  • ISPU
Aktiv komparator: Omfattande eller primär strokecenter (CSC/PSC)
CSC/PSC-personal kommer att fortsätta med vården som tillhandahålls under den gemensamma kommissionens certifierade CSC/PSC-designen, inklusive ett 30-dagars klinikbesök efter utskrivning, uppföljande klinikbesök som rekommenderas av deras polikliniska leverantör och andra klinikbesök initierade av patienten när problem uppstår. Primära resultat kommer att bedömas per telefon vid 3, 6 och 12 månader; sekundära resultat kommer att bedömas efter 3, 6 och 12 månader.
Övrig: Omfattande eller Primär Stroke Center
Primära och sekundära resultat kommer att bedömas efter 3, 6 och 12 månader.
Andra namn:
  • CSC/PSC

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Stroke Impact Scale (SIS) at 12-months Post-discharge
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Stroke Impact Scale (SIS) at 3-months Post-discharge
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 12-months post-stroke
Rehospitalization following stroke will be assessed/confirmed with study personnel.
12-months post-stroke
Recurrence
Tidsram: 12-months post-stroke
Recurrence of stroke will be assessed/confirmed with study personnel.
12-months post-stroke
Time at Home
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Vanderbilt University Medical Center

Samarbetspartners

Patient-Centered Outcomes Research Institute
University of Alabama at Birmingham

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 februari 2020

Primärt slutförande (Faktisk)

30 september 2024

Avslutad studie (Faktisk)

30 september 2024

Studieregistreringsdatum

Först inskickad

25 juni 2019

Först inskickad som uppfyllde QC-kriterierna

26 juni 2019

Första postat (Faktisk)

27 juni 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 april 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • C3FIT

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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