ENGAGE-TBI Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Client Satisfaction Questionnaire-8
研究概览
简要总结
This study will first evaluate the feasibility of delivering the ENGAGE-TBI intervention in a community setting with adults with TBI.
详细描述
Social isolation is a prevalent and highly prioritized concern among people with traumatic brain injury (TBI), contributing to poor physical and mental health outcomes. Existing rehabilitation interventions have focused primarily on remediating underlying impairments, with limited success in improving social participation. A patient-directed, self-management approach may offer a promising alternative. This study aims to evaluate the feasibility of ENGAGE-TBI, a novel, theory-driven occupational therapy intervention designed to reduce social isolation by increasing social participation among community-dwelling adults with TBI. Using a single-group pre-post design, this study will enroll 30 adults with TBI recruited through the Brain Injury Association of Missouri. ENGAGE-TBI is a 12-session group intervention co-facilitated by an occupational therapist and a peer mentor with TBI. The intervention integrates three core elements - social learning, guided problem-solving, and skilled community practice - delivered across six weeks. Feasibility outcomes include fidelity, participant engagement, satisfaction, attendance, and retention. The primary clinical outcome is social participation, measured using the PROMIS Ability to Participate in Social Roles and Activities. Feasibility outcomes will be examined descriptively against pre-specified benchmarks. Within-group Cohen's d effect sizes with 95% confidence intervals will be calculated to estimate intervention effects and variability, informing the design of a future randomized controlled trial. Findings will support the development of a fully-powered effectiveness trial. This study addresses a critical gap in TBI rehabilitation by testing a stakeholder-informed, community-based intervention that treats TBI as a chronic condition and prioritizes patient-directed goal achievement over impairment remediation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •at least 18 years old
- •experienced a TBI > 6 months prior to enrollment, confirmed by a physician as documented in their medical record
- •live in the St. Louis area
- •report problems with social participation (retention of < 80% of pre-TBI social activities as measured by Activity Card Sort)
排除标准
- •insufficient English language fluency to participate in the group intervention
- •have active substance use disorder (PRIME-MD MINI)
- •have an untreated psychotic disorder (PRIME-MD MINI)
- •have severe memory impairment that would limit their ability to recall strategies with support (Montreal Cognitive Assessment, < 21)
研究组 & 干预措施
ENGAGE-TBI
The outcome measures for feasibility will be participant satisfaction (Client Satisfaction Questionnaire-8), intervention fidelity, engagement in intervention (Pittsburgh Rehabilitation Participation Scale), attendance rate, and retention rate.
干预措施: Social intervention study for TBI survivors (Behavioral)
结局指标
主要结局
Client Satisfaction Questionnaire-8
时间窗: Post-Treatment (6-weeks)
8-item measure of intervention satisfaction with a 4-point Likert scale (8-32); higher scores indicate greater satisfaction
Pittsburgh Rehabilitation Participation Scale
时间窗: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
Interventionist-administered measure of engagement in each intervention session; reported on a 1-6 scale, with higher scores indicating greater participation.
PROMIS Ability to Participate in Social Roles and Activities
时间窗: Baseline, Post-Treatment (6-weeks)
Computer adaptive test examining social participation abilities; scores reported as T-scores
PROMIS (Patient-Reported Outcome Measures Information System) Ability to Participate in Social Roles and Activities
时间窗: Baseline, Post-Treatment (6-weeks)
Computer adaptive test examining social participation abilities; scores reported as T-scores (0-100 scale, with higher scores indicating greater participation)
次要结局
- PROMIS Social Isolation(Baseline, Post-Treatment (6-weeks))
- PROMIS-29(Baseline, Post-Treatment (6-weeks))
- PROMIS (Patient-Reported Outcome Measures Information System) Social Isolation(Baseline, Post-Treatment (6-weeks))
- PROMIS-29 (Patient-Reported Outcome Measures Information System)(Baseline, Post-Treatment (6-weeks))
研究者
Jessica Kersey
Jessica Kersey, PhD, OTR/L Assistant Professor
Washington University School of Medicine