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

NCT ID: NCT05169645

Last Updated: 2021-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-02-01

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

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

Conditions

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Chronic Spontaneous Urticaria

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CSUA patients

CSUA patients

Physical activity monitoring - Symptom monitoring

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. James's Hospital, Ireland

OTHER

Sponsor Role lead

Responsible Party

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Dr. Katie Ridge

Immunology specialist registrar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Niall Conlon

Role: PRINCIPAL_INVESTIGATOR

St. James's Hospital, Ireland

Locations

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St. James's Hospital

Dublin, , Ireland

Site Status

Countries

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Ireland

Central Contacts

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Katie Ridge

Role: CONTACT

Phone: 014162928

Email: [email protected]

Facility Contacts

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Katie Ridge

Role: primary

Other Identifiers

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ATHENACX

Identifier Type: -

Identifier Source: org_study_id