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协调、协作、全面、以家庭为基础、综合、技术支持的中风护理 (C3FIT)

2026年4月23日 更新者:Kenneth Gaines、Vanderbilt University Medical Center

C3FIT(协调、协作、全面、以家庭为基础、综合、技术支持的护理):中风的随机试验

中风是美国 (US) 的第五大死亡原因和成人残疾的主要原因。 中风是一种复杂的疾病,具有多种相互作用的风险因素(包括遗传、高血压和胆固醇,以及生活方式因素,如吸烟、饮食和运动),可导致初次和复发性中风。 高达 90% 的中风幸存者有一些影响身心健康的功能缺陷。

缺乏确定最佳中风护理服务设计的科学证据。 我们完成了为期三年的医疗保险和医疗补助服务中心 (CMS) 医疗保健创新奖,该奖测试了一种称为综合实践单元 (IPU) 的新中风护理设计。 该 IPU 是根据来自患者、护理人员、护士、中风专家、康复专家、患者权益团体、付款人和技术公司的利益相关者的意见而制定的。 这种 IPU 设计可减少住院时间、再入院率和中风复发率,并降低成本。

在 CMS 研究的基础上,开发了一个更大的、实用的试验,称为 C3FIT(协调、协作、综合、以家庭为基础、综合和技术支持的中风护理)。 C3FIT 将随机分配 18 个美国医院地点,以继续进行联合委员会认证的综合/初级 (CSC/PSC) 设计或用于中风护理的新型综合中风实践单元 (ISPU) 设计。 C3FIT 的 ISPU 使用基于团队的增强型协作(称为 Stroke Central),并跟踪患者从急诊科 (ED) 到出院后 12 个月的情况(称为 Stroke Mobile)。 Stroke Mobile 包括一个护士和外行健康教育团队,他们在家中或在康复或专业护理机构拜访患者和护理人员,以使用远程医疗技术评估功能和生活质量,以促进与多个提供者的联系。 C3FIT 的结果将提供高质量的科学证据,以确定最佳的中风护理设计,确保患者和护理人员的健康。

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

1196

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准:

  • 18 岁以上。
  • 与脑出血或缺血性中风(包括正常脑扫描)兼容的脑成像的急性中风的临床诊断;参见表 4 中的 ICD 10 代码。
  • 讲英语或西班牙语的科目。
  • 患者在中风事件发生后 7 天内入院。
  • 病人活着出院,没有接受临终关怀。
  • 出院时居住在该 C3FIT 站点招募地区的患者。
  • 病前 mRS Rankin 评分为 0-1。
  • 患者和/或代理人在知情同意程序后同意参与。
  • 去康复住院治疗或其他护理机构的患者有资格,只要他们居住在招募的地理区域并且不去临终关怀。

排除标准:

  • 临床短暂性脑缺血发作 (TIA)38-41 被排除在外,即使存在与就诊时的临床综合征相对应的计算机断层扫描 (CT) 或磁共振成像 (MRI) 病变。
  • 已经参加或计划参加另一项临床试验,参与 C3FIT 将在结果的后续评估或继续参加 C3FIT 方面受到影响。
  • 在同意之前计划接受临终关怀的患者。
  • 由于神经系统或其他医学状况(即晚期癌症、临终关怀、心脏病等),预计无法存活 1 年的患者。
  • 现场调查员认为不能参与后续护理的患者。
  • 受试者或法定监护人/代表不能或不愿意理解和配合研究程序或提供知情同意。

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:综合中风练习单元 (ISPU)
ISPU 人员将继续根据联合委员会认证的 CSC/PSC 设计提供护理,包括出院后 30 天的门诊就诊。 这将得到一个更加综合的模型的补充,该模型旨在通过基于团队的举措在中风护理的连续统一体中加强协调——从急性和住院护理到出院后 12 个月。 护理团队将每月在家中或康复/专业护理机构对患者进行 12 次随访,以评估康复情况、管理风险因素、增进理解并为患者和护理人员建立积极的行为改变。 主要结果将在 3、6 和 12 个月时通过电话进行评估;次要结果将在 3、6 和 12 个月时进行评估。
护理团队将每月在家中或康复/专业护理机构对患者进行 12 次随访,以评估康复情况、管理风险因素、增进理解并为患者和护理人员建立积极的行为改变。 将在 3、6 和 12 个月时评估主要和次要结果。
其他名称:
  • ISPU
有源比较器:综合或初级中风中心 (CSC/PSC)
CSC/PSC 人员将继续根据联合委员会认证的 CSC/PSC 设计提供护理,包括出院后 30 天门诊就诊、门诊提供者推荐的门诊随访以及由 CSC 发起的其他门诊就诊出现问题时耐心等待。 主要结果将在 3、6 和 12 个月时通过电话进行评估;次要结果将在 3、6 和 12 个月时进行评估。
将在 3、6 和 12 个月时评估主要和次要结果。
其他名称:
  • CSC/PSC

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Stroke Impact Scale (SIS) at 12-months Post-discharge
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Stroke Impact Scale (SIS) at 3-months Post-discharge
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:12-months post-stroke
Rehospitalization following stroke will be assessed/confirmed with study personnel.
12-months post-stroke
Recurrence
大体时间:12-months post-stroke
Recurrence of stroke will be assessed/confirmed with study personnel.
12-months post-stroke
Time at Home
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Kenneth Gaines, MD、Vanderbilt University Medical Center
  • 首席研究员:Barry Jackson
  • 首席研究员:George Howard, DrPH、University of Alabama at Birmingham

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年2月25日

初级完成 (实际的)

2024年9月30日

研究完成 (实际的)

2024年9月30日

研究注册日期

首次提交

2019年6月25日

首先提交符合 QC 标准的

2019年6月26日

首次发布 (实际的)

2019年6月27日

研究记录更新

最后更新发布 (实际的)

2026年5月15日

上次提交的符合 QC 标准的更新

2026年4月23日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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