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Self-Management Training Among Individuals With TBI

2026年7月27日 更新者:Boston University Charles River Campus

Chronic Disease Self-Management Among Individuals With TBI

Traumatic brain injury (TBI) can have long-term and chronic effects on an individual's physical, social, and emotional health, impacting quality of life and the ability to engage in meaningful life roles. Despite the potential for long-term effects, much of the care for individuals with TBI is front-loaded in the weeks to months post-injury. Self-management and self-management training are key components of long-term care for many chronic health conditions, but they are not standard parts of care for individuals with TBI.

In this study the investigators will address two objectives: 1) identify self-management priorities from the perspectives of individuals with chronic TBI, families, and health care providers and 2) pilot test an existing virtual community-based self-management training program (the Chronic Disease Self-Management Program (CDMSP)), to a) evaluate changes in quality of life, self-management self-efficacy, and other patient-reported outcomes before and after participating in the training, and b) identify barriers and facilitators to participating in community-based self-management training.

研究概览

研究类型

介入性

注册 (估计的)

85

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。

学习联系方式

  • 姓名:Emily Evans, PT, PhD
  • 电话号码:(617) 353 7493
  • 邮箱:eaevans@bu.edu

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Aged ≥18 years at time of first TBI
  • At least one year since the most recent TBI
  • Received care at BMC's Concussion/TBI program for a TBI or concussion
  • At least partially involved in Self-care
  • Able to provide consent
  • Able to speak and understand English
  • Available for study duration.

Exclusion Criteria:

  • • Aged <18 at the time of their first TBI

    • Severe mental, cognitive, social, or emotional difficulties due to another neurologic, developmental, psychological condition, or active substance use disorder
    • Participating in another interventional clinical trial
    • Planned major surgery in the next 4 months.
    • Pregnancy (self-report).
    • Suspected or known drugs or alcohol abuse
    • Endorses suicidal ideation
    • All individuals with reduced decision-making capacity, an assigned LAR, or conservator.

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:支持治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Self-management training
Individuals enrolled in this arm will participate in a community-based self management training program
Individuals will participate in a 6-week group training course run by a community-based organization that provides training in self-management skills for individuals with chronic health conditions.

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
PROMIS Self-Efficacy to Manage Chronic Disease Scale
大体时间:baseline, after the intervention on average 6 weeks
A patient reported outcome measure that assesses self-efficacy to managing chronic disease across 5 domains: Managing: Symptoms, Social Interactions, Medications, Emotions, and Daily Activities
baseline, after the intervention on average 6 weeks

次要结果测量

结果测量
措施说明
大体时间
Quality of Life After Brain Injury
大体时间:baseline, after the intervention on average 6 weeks
This tool was developed to assess quality of life among individuals with traumatic brain injury
baseline, after the intervention on average 6 weeks

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:Emily Evans, PT, PhD、Boston University Charles River Campus

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 (估计的)

2027年9月1日

初级完成 (估计的)

2029年3月1日

研究完成 (估计的)

2029年3月1日

研究注册日期

首次提交

2026年3月19日

首先提交符合 QC 标准的

2026年7月27日

首次发布 (实际的)

2026年8月3日

研究记录更新

最后更新发布 (实际的)

2026年8月3日

上次提交的符合 QC 标准的更新

2026年7月27日

最后验证

2026年2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

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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