An observational study in Chronic Spontaneous Urticaria, sponsored by St. James's Hospital, Ireland. Status unknown at 1 site in Ireland. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2021-12-27.
Sponsored by St. James's Hospital, Ireland · Observational
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.
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:
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
237 studies on the registry are indexed under Urticaria; 26 are open to participants now.
This study's planned enrollment of 40 is below the median of 162 across 52 observational studies indexed under Urticaria.
Browse Urticaria studies →St. James's Hospital, Ireland is the lead sponsor of 28 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Chronic spontaneous urticaria clinic
Exclusion Criteria:
Unable or unwilling to provide informed consent
CSUA patients
Other: Physical activity monitoring - Symptom monitoring
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
Physical activity
Step count as measured by fitbit
Time frame: Followed for 12 weeks during programme
Urticaria symptomatology
Urticaria control test score
Time frame: Followed for 12 weeks during programme
Heart rate variability
Heart rate variability
Time frame: Followed for 12 weeks during programme
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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St. James's Hospital, Ireland