ReCoUPS: Incentive-Based and Real-Time Symptom and Activity Reporting After Concussion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Participant adherence to completing daily survey
研究概览
简要总结
Physical and cognitive rest are recommended as treatment for concussion, but debate persists about the utility of this recommendation for patients recovering from concussion. In addition, patient adherence to physical and cognitive rest recommendations after concussion remains unknown. This study will measure and compare symptom and activity reports in the days and weeks after a concussion among patients randomly assigned to different incentive-based arms.
详细描述
Although physical and cognitive rest are recommended as the hallmark treatment for concussion, debate persists about the utility of this recommendation for patients recovering from a concussion. In addition, patient adherence to physical and cognitive rest recommendations after concussion remains unknown. Objective and timely measures of physical and cognitive activity will aid in defining the relationship between physical and cognitive rest and clinical outcomes, such as symptom status, in the days and weeks after a concussion. Random assignment to incentive-based arms will be used to measure patient engagement with the study protocol and a dedicated research platform that involves ecological momentary assessment (EMA), in which participants report their real-time symptoms and daily activities in response to randomly timed prompts, will be used to help assess the rest and recovery process among pediatric and adult patients after concussion.
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
- None
入排标准
- 年龄范围
- 13 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ages 13 to 64 years.
- •Presents with head injury concerning for concussion in line with criteria specified in the most recent Consensus Statement on Concussion in Sport, defined as head trauma with neurologic impairment, including, but not limited to somatic (eg, headache), cognitive (eg, feeling like in a fog) and/or emotional symptoms (eg, lability) symptoms.
- •Within approximately 5 days of injury.
- •Ownership of a smartphone to report symptoms and activities.
- •Speak English.
- •Informed consent or parental/guardian permission and child assent for those under 18 years of age.
排除标准
- •Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
研究组 & 干预措施
Streak incentive
Subjects start with no money in an account, but they earn a fixed amount with each response. In this arm, each adult report is worth $3.17 so an adult subject can earn up to $200 if he/she responds to all surveys. If an adult completes at least 75% of the reports, he/she will receive an $100 bonus for a total maximum of $300. In this arm, each child report is worth 0.52 cents so a child subject can earn up to $33 if he/she responds to all surveys. If a child completes at least 75% of the reports, he/she will receive a $17 bonus for a total maximum of $50.
干预措施: Streak incentive (Behavioral)
Loss-based incentive
Subjects start with the maximum possible compensation, but money is deducted for each missed response. Adult subjects will lose $4.76 for each missed survey. Child subjects will lose $0.79 for each missed survey.
干预措施: Loss-based incentive (Behavioral)
Flat-fee control status quo condition
Subjects will receive the maximum possible compensation at the end of the study regardless of response rate.
干预措施: Flat-fee control status quo condition (Behavioral)
Flat-Fitbit control status quo condition
Subjects will be compensated by keeping the Fitbit at the end of the study regardless of response rate.
干预措施: Flat-Fitbit control status quo condition (Behavioral)
结局指标
主要结局
Participant adherence to completing daily survey
时间窗: 21 days
This is a study where each participant is sent a short survey (PCSI instrument) three times each day for 21 days. The participant is instructed to reply to each survey within several minutes of receiving the prompt. We are interested in the extent to which participants will adhere to this instruction. Therefore, the outcome of interest is whether or not the participant replied to a given survey prompt. When we evaluate patient adherence in the data, we do this by calculating the % of survey prompts to which a given participant responded. In sum, the outcome is adherence to the survey.
次要结局
- Correlation between symptoms and cognitive activity(1-21 days)
- Time to recovery(1 to 21 days)
- Test Way to Health platform(1-21 days)
- Patient-reported activity vs. objective measures of activity(1-21 days)
- Correlation between symptoms and physical activity(1-21 days)