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临床试验/NCT06188364
NCT06188364招募中早期 1 期

Improving Traumatic Brain Injury Rehabilitation Care Transitions With Community Health Services: A Randomized Clinical Trial (CHW Intervention for TBI Care Transitions [CHWI for TBI]), a Research Project Within the TBI Model System

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年4月26日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
招募中
入组人数
126
试验地点
2
主要终点
Managing Your loved Ones Health - Care Partner Activation

研究概览

简要总结

TBI rehabilitation care transitions refer to the processes of preparing patients, families, and community-based healthcare providers for the patient's passage from inpatient rehabilitation to the home and community or to another level of care. Persons with TBI have heterogenous neurological impairment (cognitive and behavioral foremost, along with motor, sensory, and balance), that limits their functional independence and participation, and increases their risk for secondary medical conditions, injuries, rehospitalizations and early mortality

详细描述

Once people with TBI and their care partners enter the post-acute care landscape, they must navigate fragmented health care systems, interact with providers who may be unfamiliar with TBI, and discover their own services and supports. Inpatient rehabilitation provides high levels of structure and professional support that are impossible to replicate when constructing a home environment to independently manage day-to-day care. Once home, the person with TBI's physical, cognitive, behavioral, and medical needs can easily overwhelm even the most committed care partners. Community health workers (CHWs) through a combination of care coordination, advocacy, and direct service delivery, have the potential to address TBI care partners' needs, particularly those from low income and/or traditionally underserved minority groups. CHWs are well-suited to fill resource gaps that TBI care partners have difficulty finding, including: (1) finding diagnostic, treatment, and social services; (2) assisting with referrals; (3) providing health education and motivational interviewing to support behavioral health change; (4) collecting and managing clinical data; (5) facilitating productive relationships between health services and communities, and (6) offering psychosocial support.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must be adults (age 18 or older).
  • Must be primary person responsible for supervision/care needs of person with TBI post-IRF discharge.
  • The person with TBI must have been admitted to the Brain Injury Service Unit at SAI.
  • If the care partner does not live in the same residence as the person with TBI, they must provide multiple daily check-ins on day-to-day care.
  • Must agree to use mHealth (texts, calls) and possess or be eligible to acquire a smart phone.

排除标准

  • Any severe cognitive impairment that precludes the ability to provide informed consent or safely function as the care partner for a vulnerable adult with TBI.

研究组 & 干预措施

Standard of Care

Other

Transition Supports and Services (USS) that prepare care partners of persons with TBI for post-rehabilitation discharge

干预措施: Standard of Care (Other)

Experimental

Experimental

USS supplemented with community health services delivered by a certified CHW (CHW+USS) for care partners

干预措施: Experimental (Other)

结局指标

主要结局

Managing Your loved Ones Health - Care Partner Activation

时间窗: Measured at 12-weeks post-discharge

Based on 32 self-report items prompt care partners to rate agreement with caregiving activity and engagement statements. Rated "1-Completely Agree" to "4-Completely Disagree" or "0 - Not My Responsibility." Used because: Good full-scale reliability (α=0.95). Sufficiently unidimensional for Rasch modeling with acceptable fit statistics, low standard error of measurement, and good range of item difficulty (23.8 - 71.8). Good concurrent validity: (a) positive correlations w/ care partner preparedness, self-competence, and self-confidence, and (b) negative correlations with stress, anxiety, and poor mental health

次要结局

  • Patient Health Questionnaire - 4 (PHQ-4) - Care Partner Emotional Distress(Measured at 12- and 24-weeks post-discharge.)
  • Caregiver Well-Being Scale - Short Form (CWBS-SF) - Care Partner Well-Bing(Measured at 24-weeks post-discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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