Koordineret, samarbejdende, omfattende, familiebaseret, integreret, teknologiaktiveret slagtilfælde (C3FIT)
23. april 2026 opdateret af: Kenneth Gaines, Vanderbilt University Medical Center
C3FIT (Koordineret, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Care): Et randomiseret forsøg for slagtilfælde
Slagtilfælde er den 5. hyppigste dødsårsag og den hyppigste årsag til voksnes handicap i USA (USA). Slagtilfælde er en kompleks sygdom med flere interagerende risikofaktorer (herunder genetiske, højt blodtryk og kolesterol, og livsstilsfaktorer som rygning, kost og motion), der fører til indledende og tilbagevendende slagtilfælde. Op til 90 % af de, der overlever slagtilfælde, har et eller andet funktionelt underskud, der påvirker både fysisk og mental sundhed.
Der mangler videnskabelig dokumentation, der identificerer det bedste design for levering af slagtilfælde. Vi gennemførte en treårig, Centers for Medicare & Medicaid Services (CMS) Health Care Innovation Award, der testede et nyt slagtilfældeplejedesign kaldet en Integrated Practice Unit (IPU). Denne IPU blev udviklet gennem input fra interessenter fra patienter, plejere, sygeplejersker, slagtilfældespecialister, rehabiliteringsspecialister, patientgrupper, betalere og teknologivirksomheder. Dette IPU-design var forbundet med nedsat hospitalsindlæggelsestid, genindlæggelser og tilbagefald af slagtilfælde samt lavere omkostninger.
På baggrund af CMS-studiet blev der udviklet et større, pragmatisk forsøg, der kaldes C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, and Technology-enabled Stroke Care). C3FIT vil tilfældigt tildele 18 amerikanske hospitalssteder til at fortsætte Joint Commission-certificeret Comprehensive/Primary (CSC/PSC) design eller til det nye Integrated Stroke Practice Unit (ISPU) design til slagtilfældebehandling. C3FITs ISPU bruger team-baseret, forbedret samarbejde (kaldet Stroke Central) og følger patienter fra præsentation på Akutafdelingen (ED) til 12 måneder efter udskrivelsen (kaldet Stroke Mobile). Stroke Mobile omfatter et sygeplejerske og lægsundhedsunderviserteam, der besøger patienter og plejere i hjemmet eller på et rehabiliterings- eller kvalificeret sygeplejecenter for at vurdere funktion og livskvalitet ved hjælp af telehealth-teknologi for at lette adgangen til flere udbydere. Resultater fra C3FIT vil give videnskabelig evidens af høj kvalitet til at bestemme det bedste design for slagtilfældebehandling, der sikrer positivt helbred for patienter og plejere.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1196
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
- University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, Forenede Stater, 85054
- Mayo Clinic Hospital
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Connecticut
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Hartford, Connecticut, Forenede Stater, 06102
- Hartford Hospital
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Florida
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Jacksonville, Florida, Forenede Stater, 32224
- Mayo Clinic
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Georgia
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Atlanta, Georgia, Forenede Stater, 30303
- Emory University/Grady Health
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Augusta, Georgia, Forenede Stater, 30912
- Augusta University Medical Center
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Medical Center
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- University of Louisville Hospital
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89128
- Intermountain
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87131
- University of New Mexico Health Sciences Center
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Ohio
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Columbus, Ohio, Forenede Stater, 43214
- Ohio Health Riverside Methodist Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh Medical Center
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State College, Pennsylvania, Forenede Stater, 16802
- Penn State
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
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Tennessee
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Johnson City, Tennessee, Forenede Stater, 37604
- Johnson City Medical Center at Ballad Health
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Knoxville, Tennessee, Forenede Stater, 37916
- Covenant Health Fort Sanders Regional Medical Center
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Memphis, Tennessee, Forenede Stater, 38120
- Baptist Memorial Hospital
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Nashville, Tennessee, Forenede Stater, 37322
- Vanderbilt University Medical Center
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Texas
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Edinburg, Texas, Forenede Stater, 78539
- Doctors Hospital Renaissance
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53705
- University of Wisconsin Madison
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Alder 18+.
- Klinisk diagnose af akut slagtilfælde med hjernebilleddannelse forenelig med intracerebral blødning eller iskæmisk slagtilfælde (herunder normal hjerneskanning); se ICD 10-koder i tabel 4.
- Engelsk eller spansktalende fag.
- Patient indlagt inden for 7 dage efter deres indeksslagtilfælde.
- Patienten udskrives levende og ikke til hospice.
- Patient, der lever ved udskrivelsen inden for rekrutteringsgeografien til det pågældende C3FIT-sted.
- Præ-morbid mRS Rankin-score på 0-1.
- Patient og/eller surrogat giver samtykke til at deltage efter en informeret samtykkeproces.
- Patienter, der går til rehabilitering i døgnbehandling eller andre plejefaciliteter, er berettigede, så længe de bor i det geografiske område er rekruttering og ikke går på hospice.
Ekskluderingskriterier:
- Klinisk forbigående iskæmisk angreb (TIA)38-41 er udelukket, selvom der er en computeriseret tomografi (CT) eller magnetisk resonansbilleddannelse (MRI) læsion svarende til det kliniske syndrom ved præsentationen.
- Allerede tilmeldt eller planlagt tilmelding til et andet klinisk forsøg, hvor deltagelse i C3FIT ville være kompromitteret med hensyn til opfølgende vurdering af resultater eller fortsættelse i C3FIT.
- Patienter med planlagt indlæggelse på hospice forud for samtykke.
- Patienter, der ikke forventes at overleve i 1 år på grund af neurologisk eller anden medicinsk status (dvs. fremskreden cancer, hospice, hjertesygdom osv.).
- Patienter, som efter stedsundersøgerens opfattelse ikke kan inddrages i opfølgningsbehandlingen.
- Manglende evne eller uvilje hos subjekt eller juridisk værge/repræsentant til at forstå og samarbejde med undersøgelsesprocedurer eller give informeret samtykke.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Integrated Stroke Practice Unit (ISPU)
ISPU-personale vil fortsætte med pleje ydet under det Joint Commission-certificerede CSC/PSC-design, herunder et 30-dages klinikbesøg efter udskrivelsen.
Dette vil blive suppleret med en mere integreret model designet til at øge koordinationen gennem teambaserede initiativer på tværs af kontinuummet af pleje til apopleksi - fra akut og hospitalsbehandling til 12 måneder efter udskrivelse.
Plejeteams vil følge patienter i deres hjem eller rehabilitering/uddannede plejefaciliteter hver måned i 12 besøg for at vurdere bedring, håndtere risikofaktorer, øge forståelsen og opbygge positiv adfærdsændring for patienter og plejere.
Primære resultater vil blive vurderet telefonisk efter 3, 6 og 12 måneder; sekundære resultater vil blive vurderet efter 3, 6 og 12 måneder.
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Plejeteams vil følge patienter i deres hjem eller rehabiliterings-/uddannede plejefaciliteter hver måned i 12 besøg for at vurdere bedring, håndtere risikofaktorer og øge forståelsen og opbygge positiv adfærdsændring for patienter og plejere.
Primære og sekundære resultater vil blive vurderet efter 3, 6 og 12 måneder.
Andre navne:
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Aktiv komparator: Omfattende eller primært slagtilfældecenter (CSC/PSC)
CSC/PSC-personale vil fortsætte med pleje ydet under det Joint Commission-certificerede CSC/PSC-design, herunder et 30-dages klinikbesøg efter udskrivelsen, opfølgende klinikbesøg som anbefalet af deres ambulante udbyder og andre klinikbesøg iværksat af patient, når der opstår problemer.
Primære resultater vil blive vurderet telefonisk efter 3, 6 og 12 måneder; sekundære resultater vil blive vurderet efter 3, 6 og 12 måneder.
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Primære og sekundære resultater vil blive vurderet efter 3, 6 og 12 måneder.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Stroke Impact Scale (SIS) at 12-months Post-discharge
Tidsramme: 12 months post-stroke
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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.
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12 months post-stroke
|
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Modified Rankin Scale at 12 Months Post-stroke
Tidsramme: 12 months post-stroke
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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
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12 months post-stroke
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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3-months post-stroke
|
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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.
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6-months post-discharge
|
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Modified Rankin Scale (mRS) at 3-months Post-discharge
Tidsramme: 3-months post-stroke
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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
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3-months post-stroke
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Modified Rankin Scale (mRS) at 6-months Post-discharge
Tidsramme: 6-months post-discharge
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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
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6-months post-discharge
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Stroke Risk Factors - Blood Pressure Control (BP) at 3-months Post-discharge
Tidsramme: 3-months post-discharge
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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.
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3-months post-discharge
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Stroke Risk Factors-Blood Pressure (BP) at 6-months Post-discharge
Tidsramme: 6-months post-discharge
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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.
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6-months post-discharge
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Stroke Risk Factors-BP at 12-months Post-discharge
Tidsramme: 12-months post-discharge
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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.
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12-months post-discharge
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Stroke Risk Factors - Cholesterol (LDL) at 3-months Post-discharge
Tidsramme: 3-months post-discharge
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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.
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3-months post-discharge
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Stroke Risk Factors - Cholesterol (LDL) at 6-months Post-discharge
Tidsramme: 6-months post-discharge
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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.
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6-months post-discharge
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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.
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12-months post-discharge
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Stroke Risk Factors - Blood Sugar (HgBA1c) at 3-months Post-discharge
Tidsramme: 3-months post-stroke
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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.
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3-months post-stroke
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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.
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6-months post-discharge
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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.
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12-months post-discharge
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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).
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3-months post-stroke
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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).
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6-months post-stroke
|
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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
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12-months post-stroke
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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.
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3-months post-stroke
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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.
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6-months post-stroke
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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.
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12-months post-stroke
|
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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.
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3-months post-stroke
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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.
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6-months post-stroke
|
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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.
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12-months post-stroke
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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. .
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3-months post-stroke
|
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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. .
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6-months post-stroke
|
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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. .
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12-months post-stroke
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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
|
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Rehospitalization
Tidsramme: 12-months post-stroke
|
Rehospitalization following stroke will be assessed/confirmed with study personnel.
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12-months post-stroke
|
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Recurrence
Tidsramme: 12-months post-stroke
|
Recurrence of stroke will be assessed/confirmed with study personnel.
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12-months post-stroke
|
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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.
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12-months post-stroke
|
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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.
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3-months post-discharge
|
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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.
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6-months post-discharge
|
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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.
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12-months post-discharge
|
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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.
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3-months post-stroke
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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.
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6-months post-discharge
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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.
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12-months post-discharge
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Kenneth Gaines, MD, Vanderbilt University Medical Center
- Ledende efterforsker: Barry Jackson
- Ledende efterforsker: George Howard, DrPH, University of Alabama at Birmingham
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
25. februar 2020
Primær færdiggørelse (Faktiske)
30. september 2024
Studieafslutning (Faktiske)
30. september 2024
Datoer for studieregistrering
Først indsendt
25. juni 2019
Først indsendt, der opfyldte QC-kriterier
26. juni 2019
Først opslået (Faktiske)
27. juni 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. april 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C3FIT
Plan for individuelle deltagerdata (IPD)
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .