Self-Advocacy for Independent Life (SAIL) After Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Self-Advocacy Scale (SAS)
研究概览
简要总结
Traumatic brain injury (TBI) has been conceptualized as a chronic health condition, warranting self-advocacy for health management services across the lifespan. Successful self-advocacy requires a combination of cognitive and communication skills (problem solving, organization, negotiation, etc), which may be impaired following TBI. This project focuses on developing and testing the efficacy of an intervention to enhance self-advocacy skills in individuals who have sustained TBI. This two-arm, randomized controlled trial will include approximately 74 participants, recruited in 4 waves of approximately 18-20 per wave, with each wave recruited from a different geographic area of the state. The primary hypothesis states that participants receiving the treatment intervention will demonstrate significantly greater improvements in self-advocacy beliefs (SAS) from baseline to post-intervention as compared to participants in the control group. Treatment will consist of interactive 4-session workshops along with 2 booster phone calls. Control participants will receive a copy of a self-advocacy workbook after all assessments are completed. Baseline, post-treatment and two follow-up assessments will take place.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented TBI due to an external mechanical force
- •Received inpatient or outpatient rehabilitation for TBI
- •At least 9 months post TBI
- •Able to travel independently in the community
- •Able to attend intervention sessions
排除标准
- •Unable to read or speak English well enouth to complete assessments and actively participate in study intervention
- •Currently in inpatient TBI rehabilitation
- •Previously participated in a SAIL program
- •Participating in another research trial
- •Unable to perform neuropsychological baseline assessment
- •Score of 30 or above on GSES
结局指标
主要结局
Self-Advocacy Scale (SAS)
时间窗: Change in SAS score from Baseline to 23 weeks (12 weeks post-tx)
The Self-Advocacy Scale (SAS) is an eight-item 1-4 Likert rating scale (1 = not confident to 4 = very confident), conceptualized as a domain specific self-efficacy scale. The SAS is designed to measure an individual's current beliefs about his or her ability to produce desired self-advocacy outcomes. Scores range from 8 to 32 with higher scores indicative of better self-advocacy skills.
次要结局
- Personal Advocacy Activity Scale (PAAS)(Change in PAAS score from Baseline to 23 weeks (12 weeks post-tx))
- General Self Efficacy Scale (GSES)(Change in GSES score from Baseline to 23 weeks (12 weeks post-tx))
- Satisfaction With Life Scale (SWLS)(Change in SWLS score from Baseline to 23 weeks (12 weeks post-tx))
- Flourishing Scale (FS)(Change in total Flourishing Scale score from Baseline to 23 weeks (12 weeks post-tx))
- Participation Assessment with Recombined Tools-Objective (PART-O)(Change in PART-O score from Baseline to 23 weeks (12 weeks post-tx))
研究者
Lenore Hawley
Principal Investigator
Craig Hospital