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

NCT05169645 | Unknown DMC

• 1 other identifier: ATHENACX
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Spontaneous Urticaria

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

CSUA patients

CSUA patients

Other: Physical activity monitoring - Symptom monitoring

Interventions

Physical activity monitoring - Symptom monitoring OTHER

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

CSUA patients

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic spontaneous urticaria clinic

You may qualify if:

• 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

You may not qualify if:

• Unable or unwilling to provide informed consent

Sponsors & Collaborators

• St. James's Hospital, Ireland: lead

Study Sites (1)

St. James's Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Niall Conlon

  St. James's Hospital, Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Ridge

CONTACT

014162928; kridge@stjames.ie

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Immunology specialist registrar

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 27, 2021
• Study Start: February 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: February 1, 2023
• Last Updated: December 27, 2021

Record last verified: 2021-12

Locations

IE (1)