Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Koordinert, samarbeidende, omfattende, familiebasert, integrert, teknologiaktivert hjerneslagpleie (C3FIT)

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

C3FIT (koordinert, samarbeidende, omfattende, familiebasert, integrert, teknologiaktivert omsorg): En randomisert prøveperiode for hjerneslag

Hjerneslag er den femte ledende dødsårsaken og den ledende årsaken til uførhet hos voksne i USA (USA). Hjerneslag er en kompleks sykdom med flere samvirkende risikofaktorer (inkludert genetiske, høyt blodtrykk og kolesterol, og livsstilsfaktorer som røyking, kosthold og trening) som fører til innledende og tilbakevendende hjerneslag. Opptil 90 % av de som overlever hjerneslag har funksjonssvikt som påvirker både fysisk og mental helse.

Vitenskapelig bevis som identifiserer det beste design for levering av hjerneslag mangler. Vi fullførte en treårig, Centers for Medicare & Medicaid Services (CMS) Health Care Innovation Award som testet en ny slagpleiedesign kalt en Integrated Practice Unit (IPU). Denne IPU ble utviklet gjennom innspill fra interessenter fra pasienter, omsorgspersoner, sykepleiere, slagspesialister, rehabiliteringsspesialister, pasientgrupper, betalere og teknologiselskaper. Denne IPU-designen var assosiert med redusert sykehusoppholdstid, reinnleggelser og tilbakefall av hjerneslag, samt lavere kostnader.

Basert på CMS-studien ble det utviklet en større, pragmatisk studie som heter C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, and Technology-enabled Stroke Care). C3FIT vil tilfeldig tildele 18 amerikanske sykehussteder for å fortsette Joint Commission-sertifisert Comprehensive/Primary (CSC/PSC) design eller til det nye Integrated Stroke Practice Unit-designet (ISPU) for slagbehandling. C3FITs ISPU bruker teambasert, forbedret samarbeid (kalt Stroke Central) og følger pasienter fra presentasjon ved akuttmottaket (ED) gjennom 12 måneder etter utskrivning (kalt Stroke Mobile). Stroke Mobile inkluderer et sykepleier- og leghelsepedagogteam som besøker pasienter og omsorgspersoner hjemme eller ved et rehabiliterings- eller dyktig sykepleieinstitusjon for å vurdere funksjon og livskvalitet ved å bruke telehelseteknologi for å lette tilgangen til flere leverandører. Resultater fra C3FIT vil gi vitenskapelig bevis av høy kvalitet for å bestemme det beste design for hjerneslagbehandling som sikrer positiv helse for pasienter og omsorgspersoner.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

1196

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Alder 18+.
  • Klinisk diagnose av akutt hjerneslag med hjerneavbildning forenlig med intracerebral blødning eller iskemisk hjerneslag (inkludert normal hjerneskanning); se ICD 10-koder i tabell 4.
  • Engelsk eller spansktalende fag.
  • Pasienten innlagt innen 7 dager etter indeksslaghendelsen.
  • Pasienten skrives ut i live og ikke til hospice.
  • Pasient som lever ved utskrivning innenfor rekrutteringsgeografien for det C3FIT-nettstedet.
  • Pre-morbid mRS Rankin-score på 0-1.
  • Pasient og/eller surrogat gir samtykke til å delta etter en informert samtykkeprosess.
  • Pasienter som går til rehabilitering døgnbehandling eller andre omsorgstilbud er kvalifisert, så lenge de er bosatt i det geografiske området er rekruttert og ikke går til hospice.

Ekskluderingskriterier:

  • Klinisk forbigående iskemisk angrep (TIA)38-41 er utelukket selv om det er en datastyrt tomografi (CT) eller magnetisk resonanstomografi (MRI) lesjon som tilsvarer det kliniske syndromet ved presentasjonen.
  • Allerede påmeldt eller planlagt påmelding til en annen klinisk studie der deltakelse i C3FIT ville være kompromittert med hensyn til oppfølgingsvurdering av utfall eller fortsettelse i C3FIT.
  • Pasienter med planlagt innleggelse på hospice før samtykke.
  • Pasienter som ikke forventes å overleve i 1 år på grunn av nevrologisk eller annen medisinsk status (dvs. avansert kreft, hospice, hjertesykdom, etc.).
  • Pasienter som etter stedets utreder ikke kan involveres i oppfølging.
  • Manglende evne eller vilje hos fag eller juridisk verge/representant til å forstå og samarbeide med studieprosedyrer eller gi informert samtykke.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Integrert Stroke Practice Unit (ISPU)
ISPU-personell vil fortsette med omsorg gitt under Joint Commission-sertifisert CSC/PSC-design, inkludert et 30-dagers klinikkbesøk etter utskrivning. Dette vil bli supplert med en mer integrert modell designet for å øke koordineringen gjennom teambaserte tiltak på tvers av kontinuumet av omsorg for hjerneslag – fra akutt og sykehusomsorg gjennom 12 måneder etter utskrivning. Omsorgsteam vil følge pasienter i deres hjem eller rehabiliterings-/sykepleieinstitusjon månedlig i 12 besøk for å vurdere bedring, håndtere risikofaktorer, øke forståelsen og bygge positiv atferdsendring for pasienter og omsorgspersoner. Primære utfall vil bli vurdert per telefon ved 3, 6 og 12 måneder; sekundære utfall vil bli vurdert etter 3, 6 og 12 måneder.
Annen: Integrert Stroke Practice Unit
Omsorgsteam vil følge pasienter i deres hjem eller rehabiliterings-/sykepleieinstitusjon månedlig i 12 besøk for å vurdere bedring, håndtere risikofaktorer og øke forståelsen og bygge positiv atferdsendring for pasienter og omsorgspersoner. Primære og sekundære utfall vil bli vurdert etter 3, 6 og 12 måneder.
Andre navn:
  • ISPU
Aktiv komparator: Omfattende eller primært slagsenter (CSC/PSC)
CSC/PSC-personell vil fortsette med omsorg gitt under Joint Commission-sertifisert CSC/PSC-design, inkludert et 30-dagers klinikkbesøk etter utskrivning, oppfølgingsklinikkbesøk som anbefalt av deres polikliniske leverandør, og andre klinikkbesøk initiert av pasient når problemer oppstår. Primære utfall vil bli vurdert per telefon ved 3, 6 og 12 måneder; sekundære utfall vil bli vurdert etter 3, 6 og 12 måneder.
Annen: Omfattende eller primært slagsenter
Primære og sekundære utfall vil bli vurdert etter 3, 6 og 12 måneder.
Andre navn:
  • CSC/PSC

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Stroke Impact Scale (SIS) at 12-months Post-discharge
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Vanderbilt University Medical Center

Samarbeidspartnere

Patient-Centered Outcomes Research Institute
University of Alabama at Birmingham

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. februar 2020

Primær fullføring (Faktiske)

30. september 2024

Studiet fullført (Faktiske)

30. september 2024

Datoer for studieregistrering

Først innsendt

25. juni 2019

Først innsendt som oppfylte QC-kriteriene

26. juni 2019

Først lagt ut (Faktiske)

27. juni 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C3FIT

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere