Maximizing Energy After Traumatic Brain Injury: Feasibility and Effectiveness of Combined Problem Solving Therapy and Occupational Therapist Delivered Education
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- Change in Fatigue Scores (Patient-Reported Outcomes Measurement Information System - Fatigue) Between Groups At 16 Weeks
研究概览
简要总结
Traumatic brain injury (TBI) is the signature injury of the wars in Iraq and Afghanistan. Up to 73% of TBI patients endorse fatigue as their most challenging symptom.
Fatigue leads to decreased participation in everyday life and return to work. The Maximizing Energy (MAX) intervention trains individuals with TBI to manage their fatigue.
The intervention individualizes the Occupational Therapist delivered Energy Conservation Strategies education by using the framework of Problem Solving Therapy. The purpose of this single-blind randomized clinical trial was to test the effect of the Maximizing Energy (MAX) intervention for decreasing the impact and severity of post-TBI fatigue, increasing participation in everyday life and physical activity, and decreasing work disability.
详细描述
A significant proportion (50-80%) of individuals with traumatic brain injury (TBI) experience persistent fatigue and endorse it as the most distressing and challenging symptom that affects daily life. Chronic fatigue has a devastating impact on individuals because it leads to reduced participation in everyday life. Despite the high incidence of post-TBI fatigue and its impact on everyday life, these is a dearth of studies examining the effectiveness of non-pharmacological interventions for the treatment of post-TBI fatigue. This study is unique in that it will examine the effectiveness of a non-pharmacological intervention to manage post-TBI fatigue. The Maximizing Energy (MAX) Intervention, individuals with post-TBI fatigue will reduce the impact of fatigue on everyday life by actively seeking and implementing solutions for their fatigue-related problems, thus promoting their reintegration into the community.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age: 18 years or older
- •Patient lives within a 50 miles radius of the University of Pittsburgh in Oakland
- •Diagnosis of TBI atleast 6 months ago: Individuals need time to determine if they have chronic fatigue after CA.
- •Community dwelling: Community dwelling participants are more likely to be able to make environmental changes than those in institutions
- •Vision to operate a computer:
- •Presence of fatigue: Fatigue Severity Scale is a valid and reliable test used to measure the severity of fatigue on 9 fatigue-related statements on a 7 point ordinal scale. A score ≥ 4 signifies fatigue severe enough to limit daily activities.
- •No cognitive impairment
- •Functional English fluency and literacy
排除标准
- •Physical impairment: Individuals scoring < 65 on the 13 Functional Independence Measure (FIM) motor items will be excluded from the study;
- •Mood and mental health history: Individuals with a recent (less than 3 months) history of major depressive disorder, mania, hypomania, psychosis, or substance abuse as diagnosed by the PRIME-MD and the MiniInternational Neuropsychiatric Interview (MINI) unless treated or in partial remission will be excluded because their self-reports of participation in everyday life may not be reliable; and
- •Disability due to other diagnoses: history of neurologic, traumatic, or psychiatric conditions.
结局指标
主要结局
Change in Fatigue Scores (Patient-Reported Outcomes Measurement Information System - Fatigue) Between Groups At 16 Weeks
时间窗: Baseline, Week 16
The PROMIS Fatigue item banks assess a range of self-reported fatigue symptoms that likely decreases one's ability to execute daily activities and function normally in family or social roles. The computerized adaptive test version provides a mean fatigue score. The Scale uses a T-score metric in which 50 is the mean for the population and 10 is the standard deviation of that population. Higher scores equal more fatigue. Scores were obtained at baseline, Week 8, Week 12, and Week 16 for each participant, and mean scores were calculated for each group at each time point.
次要结局
- Change in Fatigue Severity Scores (Fatigue Severity Scale) Between Groups At 16 Weeks(Baseline, Week 16)
- Change in Fatigue Impact Scores (Modified Fatigue Impact Scale) Between Groups At 16 Weeks(Baseline, Week 16)
- Change in Participation Scores (Participation Objective, Participation Subjective) Between Groups At 16 Weeks(Baseline, Week 16)
- Change in Physical Activity Between Groups At 16 Weeks(Baseline, Week 16)
- Change in Perceived Work Disability (Work Role Functioning Questionnaire) Between Groups At 16 Weeks(Baseline, Week 16)
研究者
Ketki Raina
Associate Professor
University of Pittsburgh