Chronic Spontaneous UrticariaSTOP CSUANCT05169645
STOP CSUA: phySical acTivity, mOod and sleeP in Chronic Spontaneous Urticaria and Angioedema
An observational study of Chronic Spontaneous Urticaria, run by St. James's Hospital, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- Physical activity monitoring - Symptom monitoring
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- 1 Feb 2022to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chronic spontaneous urticaria clinic
Who may be able to join
- 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
Who cannot join
- Unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- To delineate the psychological symptoms encountered by this cohort of patients
- To examine whether there is a link between biofeedback data and symptoms of chronic spontaneous urticaria and angioedema (CSUA)
- To collect linked clinical data on participants with CSUA
- To inform an RCT examining the use of a digital behavioural intervention for patients with CSUA
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- Physical activity monitoring - Symptom monitoring
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity monitoring - Symptom monitoringOther
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
| Study group | Role | What they receive |
|---|---|---|
| CSUA patients | CSUA patients Receives: Other: Physical activity monitoring - Symptom monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Step count as measured by fitbit
Measured: Followed for 12 weeks during programme
Urticaria symptomatology
Urticaria control test score
Measured: Followed for 12 weeks during programme
Heart rate variability
Heart rate variability
Measured: Followed for 12 weeks during programme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start1 Feb 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Katie Ridge, St. James's Hospital, Ireland
- Investigators
- Niall Conlon, Principal investigator, St. James's Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169645
- Sponsor's protocol ID
- ATHENACX
- Acronym
- STOP CSUA
- Status last verified
- Dec 2021
- First submitted
- 13 Dec 2021
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STOP CSUA: phySical acTivity, mOod and sleeP in Chronic Spontaneous Urticaria and
- ClinicalTrials.gov ID
- NCT05169645
- Acronym / sponsor ID
- STOP CSUA / ATHENACX
- Conditions
- Chronic Spontaneous Urticaria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To delineate the psychological symptoms encountered by this cohort of patients
- To examine whether there is a link between biofeedback data and symptoms of chronic spontaneous urticaria and angioedema (CSUA)
- To collect linked clinical data on participants with CSUA
- To inform an RCT examining the use of a digital behavioural intervention for patients with CSUA
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CSUA patients | – | Other: Physical activity monitoring - Symptom monitoringCSUA patients |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chronic spontaneous urticaria clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Unable or unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity monitoring - Symptom monitoringThis 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 | Other | CSUA patients |
Primary outcome
Physical activity
Time frame: Followed for 12 weeks during programme
Step count as measured by fitbit
Urticaria symptomatology
Time frame: Followed for 12 weeks during programme
Urticaria control test score
Heart rate variability
Time frame: Followed for 12 weeks during programme
Heart rate variability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niall Conlon principal investigator
St. James's Hospital, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Spontaneous Urticaria, run by St. James's Hospital, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katie Ridge (014162928, kridge@stjames.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: Followed for 12 weeks during programme). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021.