Children, Adolescents and Their Providers: the Narcolepsy Assessment Partnership (CATNAPTM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 25
- 主要终点
- Improve Understanding of Natural History of Pediatric Narcolepsy
研究概览
简要总结
CATNAP is a patient registry designed to improve the understanding of the natural history of narcolepsy in pediatric patients. Descriptive statistics on disease characteristics will be performed.
The study has 16 active clinical sites and a virtual site that widens participation to anywhere in the United States. For more information about the study or to access the Online Patient Enrollment System, visit the CATNAP website: https://catnap.healthie.net/welcome or email catnap@pulseinfoframe.com. The Online Patient Enrollment System, CATNAP website, can also be found in the references section.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any child or adolescent with a physician-confirmed diagnosis of narcolepsy
- •Age less than 18 years
- •Willing to participate in the Registry and complete the informed consent form
- •Able to participate in English based registry
排除标准
- •Age 18 years or more
- •Fail to complete the informed consent form
结局指标
主要结局
Improve Understanding of Natural History of Pediatric Narcolepsy
时间窗: Up to 4 years
Characterize the Presentation, Identification, and Diagnosis of Narcolepsy in Pediatric Participants
时间窗: Up to 4 years
Understand Treatment Practices and Outcomes Captured by Treatment Regimen and Rational for Changes
时间窗: Up to 4 years
次要结局
- Caregiver Work Limitations Questionnaire (C-WLQ)(Up to 4 years)
- Change in Caregiver Well-being Measured by the Caregiver Well-Being Scale (Shortened)(Up to 4 years)
- Change in frequency of child ehavioral problems utilizing the Child Behavior Checklist (CBCL)(Up to 4 years)
- Work Productivity and Activity Impairment (WPAI)(Up to 4 years)
- Improvements in Quality of Life (QoL) as Measured by Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) Questionnaire(Up to 4 years)
- QoL - Pediatric Quality of Life Inventory (PedsQL)(Up to 4 years)
- Patient Reported Outcomes Measurement Information System (PROMIS) Peer Relationship-Parent Proxy Short Form v2.0(Up to 4 years)
- Change in Level of Social Support using the Social Support Survey Instrument(Up to 4 years)
- Change in Pittsburgh Sleep Quality index (PSQI) scores(Up to 4 years)