Real-Time Monitoring of Fatigue In Daily Life Among Adults With Cerebral Palsy or Acquired Brain Injury: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Ecological Momentary Assessment: "Fatigue item"
研究概览
简要总结
The goal of this observational study is to learn about levels and patterns of fatigue in adults with cerebral palsy (CP) and acquired brain injury (ABI) in daily life.
The main question it aims to answer is: How do adults with CP and ABI experience fatigue in daily life?
Researchers will compare data from CP and ABI with healthy volunteers to see if they experience fatigue differently.
Participants will:
- Monitor their symptoms, mood, and behavior in real-time by completing a brief survey on their mobile phone 10 times a day for seven consecutive days.
- Attend a briefing session the day prior to the seven-day period of real-time monitoring.
- Wear an accelerometer for the seven-day period.
- Complete a daily sleep diary for the seven-day period.
- Receive feedback on their real-time monitoring data, sleep and activity data.
详细描述
Fatigue is a major problem for adults with cerebral palsy (CP) or acquired brain injury (ABI), and contributes to disability, loss of productivity, and poor quality of life.
Qualitative research indicates that fatigue symptoms are dynamic and context-dependent, and the severity of symptoms can fluctuate throughout the day and from day to day.
People living with fatigue may tire more easily, in response to physical or mental exertion, than people without fatigue. Symptoms of fatigue may worsen dramatically and unexpectedly from one moment to the next. It can be very difficult for people to figure out, why they are suddenly overwhelmed by fatigue and to anticipate when symptoms will worsen again.
To help people manage their fatigue, assessment and treatment approaches need to encompass the daily fluctuations and their interaction over time with activities of daily living.
Ecological momentary assessment (EMA) is a well-established method for capturing everyday experiences, including thoughts and behaviors, in their immediate context. As they go about their everyday lives, respondents are prompted multiple times a day, on a mobile device, to answer a brief set of questions about their momentary, "here and now", experience, e.g., "how happy are you right now?". On traditional self-report instruments, such as questionnaires, rating scales, and diaries, respondents are required to recall information or report on their beliefs and attitudes, which introduce risks of bias to the assessment attributable to memory limitations, personal beliefs, and self-perception. By sampling everyday experiences in real-time, EMA reduces these biases and errors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Score of minimum 4 on the 7-item Fatigue Severity Scale (CP and ABI only)
- •Speak, read, and write Danish
- •Living in a private residence (i.e., not in institutional care or facilities providing 24-hour assistance)
- •Able to walk independently or with assistive devices over short distances
- •Able to operate a smartphone independently
- •Additional inclusion criteria for CP specifically:
- •Self-reported diagnosis of CP
- •Gross Motor Function Classification System (GMFCS) level ≤ II
- •Communication Function Classification System level ≤ II
- •Additional inclusion criteria for ABI specifically:
- •Self-reported diagnosis of ABI, including stroke, traumatic brain injury, brain infections, toxins, anoxia, or encephalopathy (transient ischemic attack, concussion or post-concussion syndrome, intracranial tumors, or progressive brain diseases are not included)
- •Between three months and two years post-injury
- •modified Rankin Scale (mRS) score ≤ 3
排除标准
- •History of other neurological disorders or chronic fatigue syndrome requiring treatment
- •Current substance or alcohol abuse
- •Night shift work or travel across time zones (1 to 3 zones within the last week or 4 to 6 zones within the last two weeks or at least 7 zones within the last 4 weeks)
结局指标
主要结局
Ecological Momentary Assessment: "Fatigue item"
时间窗: 10 times a day over 7 consecutive days
A single item variable: "How tired do you feel right now?" Rated on an 11-point slider scale ranging from 0 (no fatigue) to 10 (severe fatigue).
次要结局
- Ecological Momentary Assessment "Exhaustion item"(10 times a day over 7 consecutive days)
- Ecological Momentary Assessment "Pain item"(10 times a day over 7 consecutive days)
- Consensus Sleep Diary (CSD)(1 time a day over 7 consecutive days)
- SENS motion® activity sensor(7 consecutive days)
- Ecological Momentary Assessment: "Fatigue domain item"(10 times a day over 7 consecutive days)
- Ecological Monetary Assessment: "Alert item"(10 times a day over 7 consecutive days)
- Ecological Momentary Assessment "Sleepy item"(10 times a day over 7 consecutive days)
- Ecological Momentary Assessment: "Happiness item"(10 times a day over 7 consecutive days)
- Ecological Momentary Assessment: "Sadness item"(10 times a day over 7 consecutive days)
- Ecological Momentary Assessment: "Anxious item"(10 times a day over 7 consecutive days)
- Ecological Momentary Assessment: "Irritability item"(10 times a day over 7 consecutive days)
- Ecological Momentary Assessment: "Activity item"(10 times a day over 7 consecutive days)
- Ecological Momentary Assessment "Energy item"(10 times a day over 7 consecutive days)
- Ecological Momentary Assessment: "Concentration item"(10 times a day over 7 consecutive days)
- Ecological Momentary Assessment: "Effort item"(10 times a day over 7 consecutive days)
- Ecological Momentary Assessment: "Physical demand item"(10 times a day over 7 consecutive days)
- Ecological Momentary Assessment: "Mental demand item"(10 times a day over 7 consecutive days)
- Ecological Momentary Assessment: "Motivation item"(10 times a day over 7 consecutive days)
- Ecological Momentary Assessment: "Location item"(10 times a day over 7 consecutive days)
- Ecological Momentary Assessment: "Sensory load item"(10 times a day over 7 consecutive days)
- Ecological Momentary Assessment: "Company item"(10 times a day over 7 consecutive days)
研究者
Frederik Dornonville de la Cour
Postdoc
Rigshospitalet, Denmark