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조정, 협력, 종합, 가족 기반, 통합, 기술 지원 뇌졸중 치료 (C3FIT)

2026년 4월 23일 업데이트: Kenneth Gaines, Vanderbilt University Medical Center

C3FIT(Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Care): 뇌졸중에 대한 무작위 시험

뇌졸중은 미국(US)에서 5번째 주요 사망 원인이자 성인 장애의 주요 원인입니다. 뇌졸중은 초기 및 재발성 뇌졸중으로 이어지는 여러 상호작용 위험 요인(유전, 고혈압 및 콜레스테롤, 흡연, 식이요법 및 운동과 같은 생활 습관 요인 포함)이 있는 복잡한 질병입니다. 뇌졸중 생존자의 최대 90%는 신체적, 정신적 건강에 영향을 미치는 일부 기능적 결함이 있습니다.

최고의 뇌졸중 치료 전달 설계를 식별하는 과학적 증거가 부족합니다. 우리는 IPU(Integrated Practice Unit)라고 하는 새로운 뇌졸중 치료 설계를 테스트한 3년 간의 Centers for Medicare & Medicaid Services(CMS) 건강 관리 혁신상을 완료했습니다. 이 IPU는 환자, 간병인, 간호사, 뇌졸중 전문의, 재활 전문가, 환자 옹호 단체, 지불인 및 기술 회사의 이해관계자 의견을 통해 개발되었습니다. 이 IPU 설계는 입원 기간, 재입원, 뇌졸중 재발 감소 및 비용 절감과 관련이 있습니다.

CMS 연구를 기반으로 C3FIT(Coordinated, Collaborative, Comprehensive, Family-based, Integrated, and Technology-enabled Stroke Care)라는 더 크고 실용적인 시도가 개발되었습니다. C3FIT는 18개의 미국 병원 사이트를 무작위로 할당하여 Joint Commission 인증 Comprehensive/Primary(CSC/PSC) 설계 또는 뇌졸중 치료를 위한 새로운 ISPU(Integrated Stroke Practice Unit) 설계를 계속할 것입니다. C3FIT의 ISPU는 팀 기반의 향상된 협업(Stroke Central이라고 함)을 사용하고 응급실(ED)에서 퇴원 후 12개월(Stroke Mobile이라고 함)까지 환자를 추적합니다. Stroke Mobile에는 집이나 재활 또는 전문 간호 시설에서 환자와 간병인을 방문하여 원격 의료 기술을 사용하여 기능과 삶의 질을 평가하는 간호사 및 일반 건강 교육자 팀이 포함되어 여러 공급자에 대한 액세스를 용이하게 합니다. C3FIT의 결과는 환자와 간병인의 긍정적인 건강을 보장하는 최고의 뇌졸중 치료 설계를 결정하기 위한 고품질의 과학적 증거를 제공할 것입니다.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

1196

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  • 18세 이상.
  • 뇌내 출혈 또는 허혈성 뇌졸중과 호환되는 뇌 영상으로 급성 뇌졸중의 임상 진단(정상 뇌 스캔 포함) 표 4의 ICD 10 코드를 참조하십시오.
  • 영어 또는 스페인어 말하기 과목.
  • 환자는 지표 뇌졸중 발생 후 7일 이내에 입원했습니다.
  • 환자는 호스피스 치료를 받지 않고 살아서 퇴원합니다.
  • 해당 C3FIT 사이트에 대한 모집 지역 내 퇴원에 거주하는 환자.
  • 0-1의 병적 전 mRS Rankin 점수.
  • 환자 및/또는 대리인은 정보에 입각한 동의 절차를 거친 후 참여에 동의합니다.
  • 재활 입원 치료 또는 기타 치료 시설을 이용하는 환자는 모집 지역에 거주하고 호스피스 치료를 받지 않는 한 자격이 있습니다.

제외 기준:

  • 임상적 일과성 허혈 발작(TIA)38-41은 내원 당시 임상 증후군에 해당하는 컴퓨터 단층 촬영(CT) 또는 자기 공명 영상(MRI) 병변이 있더라도 제외됩니다.
  • 결과에 대한 후속 평가 또는 C3FIT 지속과 관련하여 C3FIT 참여가 위태로워질 수 있는 다른 임상 시험에 이미 등록했거나 등록할 예정입니다.
  • 동의 전에 호스피스 케어에 계획된 입원이 있는 환자.
  • 신경학적 또는 기타 의학적 상태(즉, 진행성 암, 호스피스 케어, 심장병 등)로 인해 1년 동안 생존할 것으로 예상되지 않는 환자.
  • 현장 조사관의 의견에 따라 후속 치료에 참여할 수 없는 환자.
  • 피험자 또는 법적 보호자/대리인이 연구 절차를 이해하고 협조하거나 정보에 입각한 동의를 제공할 능력이 없거나 의지가 없음.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: ISPU(Integrated Stroke Practice Unit)
ISPU 직원은 퇴원 후 30일 클리닉 방문을 포함하여 Joint Commission 인증 CSC/PSC 설계에 따라 제공되는 치료를 계속할 것입니다. 이는 급성 및 병원 내 치료에서 퇴원 후 12개월까지 뇌졸중 치료의 연속체 전반에 걸쳐 팀 기반 이니셔티브를 통해 조정을 강화하도록 설계된 보다 통합된 모델로 보완될 것입니다. 케어 팀은 회복을 평가하고, 위험 요인을 관리하고, 이해를 높이고, 환자와 간병인을 위한 긍정적인 행동 변화를 구축하기 위해 매달 12회 방문 동안 가정 또는 재활/전문 간호 시설에서 환자를 추적할 것입니다. 1차 결과는 3, 6, 12개월에 전화로 평가됩니다. 2차 결과는 3, 6, 12개월에 평가됩니다.
다른: 통합 뇌졸중 연습 단위
케어 팀은 회복을 평가하고, 위험 요인을 관리하고, 이해를 높이고, 환자와 간병인을 위한 긍정적인 행동 변화를 구축하기 위해 매달 12회 방문 동안 가정 또는 재활/전문 요양 시설에서 환자를 추적할 것입니다. 1차 및 2차 결과는 3, 6, 12개월에 평가됩니다.
다른 이름들:
  • ISPU
활성 비교기: 종합 또는 일차 뇌졸중 센터(CSC/PSC)
CSC/PSC 직원은 퇴원 후 30일간의 진료소 방문, 외래환자 서비스 제공자가 권장하는 후속 진료소 방문, 그리고 병원에서 시작한 기타 진료소 방문을 포함하여 Joint Commission 인증 CSC/PSC 설계에 따라 제공되는 치료를 계속할 것입니다. 문제가 발생하면 인내심을 가지십시오. 1차 결과는 3, 6, 12개월에 전화로 평가됩니다. 2차 결과는 3, 6, 12개월에 평가됩니다.
다른: 종합 또는 일차 뇌졸중 센터
1차 및 2차 결과는 3, 6, 12개월에 평가됩니다.
다른 이름들:
  • CSC/PSC

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Stroke Impact Scale (SIS) at 12-months Post-discharge
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Stroke Impact Scale (SIS) at 3-months Post-discharge
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 12-months post-stroke
Rehospitalization following stroke will be assessed/confirmed with study personnel.
12-months post-stroke
Recurrence
기간: 12-months post-stroke
Recurrence of stroke will be assessed/confirmed with study personnel.
12-months post-stroke
Time at Home
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Vanderbilt University Medical Center

협력자

Patient-Centered Outcomes Research Institute
University of Alabama at Birmingham

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 2월 25일

기본 완료 (실제)

2024년 9월 30일

연구 완료 (실제)

2024년 9월 30일

연구 등록 날짜

최초 제출

2019년 6월 25일

QC 기준을 충족하는 최초 제출

2019년 6월 26일

처음 게시됨 (실제)

2019년 6월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 23일

마지막으로 확인됨

2026년 4월 1일

추가 정보

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키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • C3FIT

개별 참가자 데이터(IPD) 계획

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