Symptom-Targeted Approach to Rehabilitation for Concussion: STAR-C
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 4
- 主要终点
- Key Behaviors Change Inventory (KBCI)
研究概览
简要总结
Throughout the course of the wars in Iraq and Afghanistan, more than 250,000 service members sustained traumatic brain injuries, mostly characterized as mild traumatic brain injuries (mTBI) or concussions. While most with mTBI recover over days to weeks, a significant percentage continue to experience post-concussive symptoms such as headaches, cognitive difficulties, and dizziness for months to years. As a result, treatment of post-concussive symptoms after mTBI is of significant importance in the Department of Defense and Veterans healthcare systems.
Several studies have shown that cognitive rehabilitation can be effective for individuals with mTBI, including Service Members and Veterans with post concussive symptoms. Cognitive rehabilitation is a type of treatment in which patients work with a therapist to improve everyday memory and thinking skills and develop strategies to reduce the impact of cognitive difficulties in their everyday lives. While these treatments have great potential benefits, protocols studied to date are time intensive, requiring up to 60 hours of treatment. These time demands are impractical for many Service Members and Veterans, and place a time-burden on clinics providing the treatment.
The current study proposes to identify key ingredients of an evidence-based cognitive rehabilitation protocol to develop a streamlined version that is feasible and acceptable to Service Members and Veterans. This briefer protocol will increase the number of Service Members and Veterans who can access treatment. To accomplish this goal the investigators will first spend six months analyzing manualized treatments from a successful cognitive rehabilitation intervention developed for Service Members. The investigators will analyze manuals using a framework developed to identify active ingredients in rehabilitation. Based on those results the investigators will develop a manualized streamlined treatment protocol, which the investigators will deliver to 25 Service Members and 50 Veterans over 18 months in person or via telehealth. The investigators will determine feasibility and acceptability of this intervention, and collect preliminary efficacy data. The project addresses access to therapy services and enhanced treatment compliance, a key barrier to participation in cognitive rehabilitation by Veterans and Service Members with TBI. Additionally, although this study focuses on Service Members and Veterans with mTBI, the investigators expect that this streamlined intervention can also be translated to civilian populations with mTBI.
详细描述
Background
The proposed work addresses the FY17/18 PH/TBIRP CTRR-CTA Focus Area of Cognitive Rehabilitation. The study will generate new knowledge about optimal cognitive rehabilitation prescription patterns, specifically frequency (number of days), intensity (number of hours per day), and type (active ingredients). The study outcome will be a treatment protocol (STAR-C) that can be delivered efficiently and effectively in person or via telehealth, to minimize functional limitations after mTBI and maximize treatment accessibility.
The STAR-C study has features of a pragmatic trial: all individuals with mTBI are invited to enroll, regardless of co-morbidities; the primary outcome is clinically meaningful and does not require special equipment or tests; aspects of the intervention will be flexible so clinicians can tailor intervention to their clients; and there are no formal strategies to ensure compliance. Also consistent with pragmatic trial methods, the investigators will include individuals from heterogeneous practice settings (DoD and VA), and use standard-of-care outcome measures.
Mild traumatic brain injury (mTBI) is a widely acknowledged cause of morbidity among Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) warfighters. Several recent studies provide incidence estimates for mTBI among combat deployed troops serving in support of OEF/OIF. In a recent population cohort study, 4.9% of over 2,500 Army infantry soldiers reported mTBI with loss of consciousness, and another 10.3% reported mTBI with altered mental status. In one cross-sectional prevalence study of OEF/OIF Service Members, 12% of the sample of over 2,200 respondents to a mail survey reported a history consistent with mTBI during deployment. Recent surveillance data obtained by the Defense and Veterans Brain Injury Center (DVBIC) from electronic medical records indicate that over the past 10 years, more than 250,000 active duty Service Members have reported sustaining a TBI, with the majority of these being mild in severity.
As Service Members separate from active duty or reserve duty status, their treatment can transition to the Veterans Health Administration (VHA), which also tracks epidemiologic data. In Fiscal Year (FY) 2014, 7% of Iraq and Afghanistan War Veterans seen in the VHA system carried a diagnosis of TBI. According to Taylor et al, the prevalence of TBI diagnosis in the VA healthcare System has remained consistent since tracking began around 2009, despite changes in incidence in the DoD following the reduction of combat operations in Iraq and Afghanistan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mTBI defined per the VA/DoD Clinical Practice Guideline for the Management of Concussion-Mild Traumatic Brain Injury (CPG; Corrigan & Bogner, 2007) sustained in any context (deployment-related or non-deployment-related) and at any time longer than 6 months previously;
- •A score of 3, 4, or 5 on any of the four Cognitive items on the NSI, to include participants who have cognitive complaints; and
- •A score on the Word Reading Subtest of the Wide Range Achievement Test of a sixth-grade reading level or higher, to ensure participants can read study materials.
- •All individuals in this study population must meet all of the inclusion criteria in order to be eligible to participate in the study
排除标准
- •History of TBI (any severity) within 6 months of enrollment.
- •History of a moderate, severe, or penetrating TBI as defined by DoD/VA guidelines.
- •Lifetime diagnosis of schizophrenia or other psychotic disorder.
- •Current participation in intensive behavioral health treatment (>5 appointments/encounters per week) for major depressive disorder, post-traumatic stress disorder (PTSD), bipolar disorder, or substance-related disorder.
- •History of a neurological disease other than mild TBI such as multiple sclerosis, cerebral vascular accident, brain tumor, neurodegenerative disease, or neuro-motor disorder.
- •Current, active suicidal or homicidal ideation.
- •A score of <45 on Trial 2 of the Test of Memory Malingering, or a Validity 10 score of >22 from the NSI, to exclude individuals who demonstrate suboptimal effort or potential invalid self-reporting of symptoms.
- •Daily use of narcotic pain medications.
- •All individuals in this study population meeting any of the exclusion criteria at baseline will be excluded from study participation.
结局指标
主要结局
Key Behaviors Change Inventory (KBCI)
时间窗: Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment
The KBCI was designed to assess functional cognitive and behavioral changes after TBI. It is composed of 64 items rated on a 4-point scale. Response options range from "False, not at all" to "Very True"
Goal Attainment Scaling Change
时间窗: Treatment week 1, Treatment week 2, Treatment week 3, 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment
Goal attainment scaling of a minimum of three goals. Score obtained for each goal at each session. Score ranges from -1 to +3. Higher numbers indicate higher levels of goal achievement.
Common Concussive Cognitive Complaints (C4) Inventory Change
时间窗: Baseline; Treatment week 3 (last session); 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment
23 item self-report measure that lists common post-concussive cognitive complaints. The respondent rates how often specific cognitive complaints have caused trouble for them day-to-day in the two weeks preceding the measure's administration. Item scores range from 1 = "Not at All" to 5 = "All the time"
Patient Global Impression of Change (PGIC)
时间窗: Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment
Change in activity, limitations, symptoms, emotions and overall quality of life, related to painful illness. Respondents rate impression of change from 1-7, with higher scores indicating an impression of positive change, and to rate overall change on a scale ranging from 1 = "Much Better" to 10 = "Much Worse"
Neurobehavioral Symptom Inventory (NSI) Change
时间窗: Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment
22-item self-report checklist of persistent post-concussive symptoms and how much symptoms have disturbed the respondent since injury. Total score ranges from 0 to 88. Item response options range from 0="None" to 4 ="Very Severe"
次要结局
- PTSD Checklist 5 (PCL-5)(Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment)
- Center for Epidemiological Studies-Depression (CES-D)(Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment)
- Acceptability of Intervention Measure (AIM)- (Patient)(Treatment session 1(week 1), Treatment session 2 (week 1), Last Treatment session(week 3), 1 week post-treatment, 3 months post-treatment)
- Feasibility of Intervention Measure (FIM)(Treatment session 1(week 1), Treatment session 2 (week 1), Last Treatment session(week 3), 1 week post-treatment)
- Veterans Rand 36-Item Health Survey (VR-36)(Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment)
- Intervention Appropriateness Measure (IAM)(Treatment session 1(week 1), Treatment session 2 (week 1), Last Treatment session(week 3), 1 week post-treatment)
- Epworth Sleepiness Scale - Adult Version (ESS)(Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment)
- Acceptability of Intervention Measure (AIM)- (Clinician)(Treatment session 1(week 1), Treatment session 2 (week 1), Last Treatment session(week 3), 1 week post-treatment)
研究者
Blessen Eapen
Chief, Physical Medicine and Rehabilitation Service
South Texas Veterans Health Care System