STOP CSUA: phySical acTivity, mOod and sleeP in Chronic Spontaneous Urticaria and
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Urticaria symptomatology
研究概览
简要总结
Chronic spontaneous urticaria and angioedema (CSUA) is a disease of the skin characterised by hives, swellings or both that last longer than 6 weeks. People with this disease commonly describe poor sleep, reduced quality of life and psychological difficulties such as depression and anxiety. This study seeks to understand relationships between physical activity, sleep and symptoms of urticaria. We are asking individuals with urticaria to wear a fitbit tracker which monitors their physical activity and sleep. Participants also download an app onto their smartphone called Athena CX which is designed by the study team in DCU. The purpose of the app is capture real-time information from participants on mood and any skin symptoms they experience. We will use this information to learn more about possible links between symptoms of urticaria and lifestyle behaviours.
详细描述
Chronic spontaneous urticaria and angioedema (CSUA) is a disease of the skin characterised by hives, swellings or both that last longer than 6 weeks (1). A quarter of patients with this disease report impaired quality of life (2). Furthermore, individuals with CSUA are more likely to have depression and anxiety (3). In addition, our previous qualitative research findings have noted issues with self-compassion among this cohort (4). Fatigue and poor sleep are common (5). We seek to examine possible links between physical activity, sleep, mood and symptoms of urticaria.
For participants who give their consent, we will do this by collecting and exploring:
- Fitbit tracker data
- Information on mood via the Athena CX app
- Information on symptoms of urticaria via the Athena CX app
Electronic health applications for smartphones are increasingly used in chronic health conditions and have been piloted in chronic spontaneous urticaria for recording of symptoms, medication reminders and patient education. This study will develop a smartphone application designed specifically for this cohort of patients, entitled Athena CX focusing specifically upon symptomatology and mood.
An observational study collecting biofeedback data in this cohort will inform our understanding of this disease and future research.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chronic spontaneous urticaria with or without angioedema
- •Urticaria control test score < 12 indicating poorly controlled urticaria at time of consent
- •Preference to participate in the study
- •In possession of a smartphone
排除标准
- •Unable or unwilling to provide informed consent
结局指标
主要结局
Urticaria symptomatology
时间窗: Followed for 12 weeks during programme
Urticaria control test score
Heart rate variability
时间窗: Followed for 12 weeks during programme
Heart rate variability
Physical activity
时间窗: Followed for 12 weeks during programme
Step count as measured by fitbit
次要结局
未报告次要终点
研究者
Dr. Katie Ridge
Immunology specialist registrar
St. James's Hospital, Ireland