Randomized Controlled Trial of Targeted Treatment in Older Adults Following Concussion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Concussion Clinical Profiles Screening (CP Screen)
研究概览
简要总结
The purpose of this study is to conduct the first randomized control trial for targeted treatments for concussion in adults 50 years or older. Participants will be enrolled at their first concussion clinical visit (V1) and their second study visit will occur after (up to 7 days) or concurrently with the participant's second concussion clinical visit, typically (but not limited to) between 21-31 days from V1.
详细描述
Although concussion is a common occurrence in older adults, we know little about the injury in this at-risk population. Certain management tools that might be appropriate for adolescent and young adult populations may not be appropriate for use in older adults who may have sensory, cognitive, and neuro-motor limitations. This study will help to develop initial evidence for targeted treatments for concussion in older adults. The study will utilize a two group design with permuted block random assignment to intervention and usual care/control groups. All participants will complete the following assessments at their initial and follow-up visit appointments: cognitive screening (learning, memory, language, executive functioning), concussion and mood symptom questionnaires, and neuro-motor screening. The primary outcomes for this study will be total symptom severity score (i.e., symptom burden) on the Concussion Clinical Profiles Screening (CP Screen) and Patient Global Impression of Change (PGIC). Secondary outcomes will include: Short Falls Efficacy Scale (SFES), Dizziness Handicap Inventory (DHI), Patient Health Questionnaire-9 (PHQ-9), Patient Health Questionnaire-15 (PHQ-15), Generalized Anxiety Disorder - 7 (GAD-7), Posttraumatic Stress Disorder Checklist (PCL-5), Pittsburgh Sleep Quality Index (PSQI), Neuro-Quality of Life (QOL) v2.0 - Cognition Function (Short version), Headache Impact Test (HIT-6), ID Migraine, Neck Disability Index (NDI), Vestibular Ocular Motor Screen (VOMS), Timed-Up-and-Go (TUG), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). All outcomes will be treated as continuous.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 years of age or older
- •Diagnosed concussion within the last 4 days - 12 months
- •Must be recruited at their initial concussion appointment
- •Ability to read/write to complete study assessments/testing
排除标准
- •Diagnosed major psychiatric disorders other than depression/anxiety (e.g., schizophrenia)
- •Diagnosed with moderate to severe brain injury or past brain surgery/malformations
研究组 & 干预措施
Targeted Intervention
Participant receives exercises or strategies based on their clinical concussion domain given to them by their neuropsychologist: 1) Anxiety/Mood, 2)Headache/Migraine, 3)Vestibular, 4)Ocular, 5)Cognitive.
干预措施: Targeted Intervention (Behavioral)
Behavioral Control
Participants randomized to the behavioral control group will receive standardized (i.e., all participants in this group will receive the same interventions) behavioral management strategies that include activity, hydration, nutrition, sleep, and stress management strategies.
干预措施: Behavioral Control (Behavioral)
结局指标
主要结局
Concussion Clinical Profiles Screening (CP Screen)
时间窗: At study completion, an average of 30 days after Visit 1
The CP Screen is a 29 item self-report, clinical profiles based symptom inventory that measures five concussion clinical profiles: 1) anxiety/mood, 2)cognitive/fatigue, 3) migraine, 4) ocular, 5) vestibular; and two modifying factors sleep and cervical. Participants indicate on a scale of 0 (none) to 3 (severe) the level of symptom severity for each item. The CP screen yields an average factor and modifier scores, with higher scores indicative of worse symptom severity, score range is 0-87.
Concussion Clinical Profiles Screening (CP Screen)
时间窗: Visit 1 (Baseline)
The CP Screen is a 29 item self-report, clinical profiles based symptom inventory that measures five concussion clinical profiles: 1) anxiety/mood, 2)cognitive/fatigue, 3) migraine, 4) ocular, 5) vestibular; and two modifying factors sleep and cervical. Participants indicate on a scale of 0 (none) to 3 (severe) the level of symptom severity for each item. The CP screen yields an average factor and modifier scores, with higher scores indicative of worse symptom severity, score range is 0-87.
次要结局
- General Anxiety Disorder-7 (GAD-7)(At study completion, an average of 30 days after Visit 1)
- ID Migraine(At study completion, an average of 30 days after Visit 1)
- Short Falls Efficacy Scale (SFES)(At study completion, an average of 30 days after Visit 1)
- Patient Health Questionnaire-9 (PHQ-9)(At study completion, an average of 30 days after Visit 1)
- Vestibular/Ocular Motor Screening (VOMS)(At study completion, an average of 30 days after Visit 1)
- Patient Health Questionnaire-15 (PHQ-15)(At study completion, an average of 30 days after Visit 1)
- PCL-5(At study completion, an average of 30 days after Visit 1)
- Headache Impact Test-6 (HIT-6)(At study completion, an average of 30 days after Visit 1)
- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(At study completion, an average of 30 days after Visit 1)
- Percent Back to Normal(Daily between Visit 1 and study completion, an average of 30 days)
- Neuro-QOL (Cognitive Function Scale - short form)(At study completion, an average of 30 days after Visit 1)
- Dizziness Handicap Inventory (DHI)(At study completion, an average of 30 days after Visit 1)
- Neck Disability Index(At study completion, an average of 30 days after Visit 1)
- Pittsburgh Sleep Quality Index (PSQI)(At study completion, an average of 30 days after Visit 1)
- Timed-Up-and-Go(At study completion, an average of 30 days after Visit 1)
- Patient's Global Impression of Change (PGIC)(Daily between Visit 1 and study completion, an average of 30 days)
- Vestibular/Ocular Motor Screening (VOMS)(Visit 1 (Baseline))
- Short Falls Efficacy Scale (SFES)(Visit 1 (Baseline))
- Patient Health Questionnaire-9 (PHQ-9)(Visit 1 (Baseline))
- Patient Health Questionnaire-15 (PHQ-15)(Visit 1 (Baseline))
- General Anxiety Disorder-7 (GAD-7)(Visit 1 (Baseline))
- PCL-5(Visit 1 (Baseline))
- Neuro-QOL (Cognitive Function Scale - short form)(Visit 1 (Baseline))
- Dizziness Handicap Inventory (DHI)(Visit 1 (Baseline))
- Headache Impact Test-6 (HIT-6)(Visit 1 (Baseline))
- ID Migraine(Visit 1 (Baseline))
- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(Visit 1 (Baseline))
- Neck Disability Index(Visit 1 (Baseline))
- Pittsburgh Sleep Quality Index (PSQI)(Visit 1 (Baseline))
- Timed-Up-and-Go(Visit 1 (Baseline))
研究者
Anthony P. Kontos, Ph.D.
Research Director
University of Pittsburgh