STOP CSUA: phySical acTivity, mOod and sleeP in Chronic Spontaneous Urticaria and Angioedema

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Objectives To delineate the psychological symptoms encountered by this cohort of patients To examine whether there is a link between biofeedback data and symptoms of chronic spontaneous urticaria and angioedema (CSUA) To collect linked clinical data on participants with CSUA To inform an RCT examining the use of a digital behavioural intervention for patients with CSUA

Official Title
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STOP CSUA: phySical acTivity, mOod and sleeP in Chronic Spontaneous Urticaria and

Conditions
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Chronic Spontaneous Urticaria

Intervention / Treatment
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* Other: Physical activity monitoring - Symptom monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Unable or unwilling to provide informed consent

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CSUA patients<br>CSUA patients | Other: Physical activity monitoring - Symptom monitoring<br>* This is an observational study. There is no intervention outside the collection of data from participants. Consenting participants in the study will be provided with a Fitbit activity tracker and asked to wear it for a period of three months. The Fitbit measures: Physical activity using daily step count Additional physical activity entries Heart rate Sleep quality Calories burned Food log Participants will be asked to download an app onto their smart phone entitled Athena CX. This app is designed to capture: Urticaria symptomatology using the urticaria control test Symptoms of depression using 2 items from the PHQ 9 Symptoms of anxiety using two items from the GAD Short form self-compassion scale<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Step count as measured by fitbit | Followed for 12 weeks during programme | 
| Urticaria symptomatology | Urticaria control test score | Followed for 12 weeks during programme | 
| Heart rate variability | Heart rate variability | Followed for 12 weeks during programme |