Clinical trial NCT05169645: STOP CSUA: phySical acTivity, mOod and sleeP in Chronic Spontaneous Urticaria and Angioedema
Official title: STOP CSUA: phySical acTivity, mOod and sleeP in Chronic Spontaneous Urticaria and
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Spontaneous Urticaria
Lead sponsor: St. James's Hospital, Ireland
Sponsor class: OTHER
First posted: 2021-12-27
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic spontaneous urticaria clinic

Brief summary: 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: 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

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

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of chronic spontaneous urticaria with or without angioedema
2. Urticaria control test score \< 12 indicating poorly controlled urticaria at time of consent
3. Preference to participate in the study
4. In possession of a smartphone

Exclusion Criteria:

Unable or unwilling to provide informed consent

Primary outcomes:
measure: Physical activity
timeFrame: Followed for 12 weeks during programme
measure: Urticaria symptomatology
timeFrame: Followed for 12 weeks during programme
measure: Heart rate variability
timeFrame: Followed for 12 weeks during programme
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St. James's Hospital
Study officials:
affiliation: St. James's Hospital, Ireland
name: Niall Conlon
role: PRINCIPAL_INVESTIGATOR
References: