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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Other: Physical activity monitoring - Symptom monitoring

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

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Katie Ridge; Phone Number: 014162928; Email: kridge@stjames.ie

Study Locations

• Ireland
  • Dublin, Ireland
    • St. James's Hospital
    • Contact: Katie Ridge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic spontaneous urticaria clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. James's Hospital, Ireland
• Investigators: Principal Investigator: Niall Conlon, St. James's Hospital, Ireland

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): December 27, 2021

Study Record Updates

• Last Update Posted (Actual): December 27, 2021
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Skin Diseases, Vascular; Hypersensitivity; Urticaria; Chronic Urticaria
• Other Study ID Numbers: ATHENACX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No