创伤性脑损伤后护理者健康(CG-Well):随机临床试验方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
Natalie Kreitzer , Stephanie Fink , Opeolu Adeoye , Brad Kurowski G , Shari Wade , Heidi Sucharew , Tamilyn Bakas
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引用次数: 0

摘要

导言中重度创伤性脑损伤(msTBI)幸存者在受伤后主要依靠非正式的家庭照顾者。多达 77% 的家庭照护者经历了不良后果,如不利的生活变化、与健康相关的生活质量低下以及抑郁症状加重。照护者经常报告说,对他们的支持或培训少之又少,无法让他们为自己的新角色做好准备。之前开发的大多数毫秒创伤性脑损伤后照护者和照护者/幸存者组合干预措施都侧重于仅向幸存者或长期照护者提供信息,而不是向新的照护者提供信息。本手稿介绍了一项正在进行中的随机对照试验 "TBI 后照顾者健康"(CG-Well)的方案,该方案旨在为患有毫秒创伤性脑损伤的成人照顾者提供教育、支持和技能培训,从幸存者的早期临床病程开始。方法在重症监护室入院两周内,参与者被随机分配到 CG-Well 在线模块(干预组,n = 50 对)或信息、支持和转介(ISR)电子公告(对照组,n = 50 对),这些电子公告存在于公共领域(对照组,n = 50 对)。两组都会定期接到电话。主要结果是六个月后的干预满意度。结果招募工作于 2022 年 3 月开始,预计于 2024 年 10 月结束。目前,我们已招募了约 70% 的参与者。讨论该研究旨在评估护理人员的满意度,方法是满足毫秒创伤性脑损伤护理人员在入住重症监护室期间对量身定制的支持性护理的需求:NCT05307640。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Caregiver Wellness after Traumatic Brain Injury (CG-Well): Protocol for a randomized clinical trial

Introduction

After injury, survivors of moderate to severe traumatic brain injury (msTBI) depend on informal family caregivers. Upwards of 77 % of family caregivers experience poor outcomes, such as adverse life changes, poor health-related quality of life, and increased depressive symptoms. Caregivers frequently report minimal support or training to prepare them for their new role. The majority of previously developed caregiver and caregiver/survivor dyad interventions after msTBI focus on providing information to either survivors only, or to long-term caregivers, rather than to the new caregiver. This manuscript describes the protocol of an ongoing randomized control trial, Caregiver Wellness after TBI (CG-Well), developed to provide education, support, and skill-building to caregivers of adults with msTBI, beginning when the survivor is early in the clinical course.

Methods

Within two weeks of admission to the ICU, participants are randomized to CG-Well online modules (intervention group, n = 50 dyads) or information, support, and referral (ISR) e-bulletins that exist in the public domain (control group, n = 50 dyads) over the first six months after their family member's msTBI. Both groups receive regular phone calls. The primary outcome is intervention satisfaction at six months.

Results

Enrollment began in March 2022 and is projected to complete October 2024. We have enrolled approximately 70 % of participants at this time. Primary analysis completion is anticipated April 2025.

Discussion

This RCT is designed to evaluate caregiver satisfaction by addressing the need for tailored supportive care for caregivers of msTBI beginning during the ICU admission.

Trial registration

Clinicaltrials. gov Registration Number: NCT05307640.

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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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