- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05727306
Healthcare Disparities in Alopecia Areata
Healthcare Disparities in Alopecia Areata: UK Population-based Cohort Study
Alopecia areata (AA) is a common immune-mediated non-scarring alopecia often associated with substantial morbidity. There are however, limited population-based data on potential disparities in the burden of AA, including across people of different ethnicities and deprivation.
We aimed to provide the first large-scale, population-based estimate of lifetime risk of AA overall and by important sociodemographic subgroups. As AA is associated with an increased burden of mental health conditions and work-related outcomes (unemployment, time off work), a detailed understanding of the burden of disease in different sociodemographic groups is vital to plan resource provision.
Study Overview
Detailed Description
The overall purpose of the study is to provide an estimate of the cumulative lifetime incidence of AA in the population overall and by important sociodemographic groups. Moreover, to do a subgroup analysis in the AA population to identify health-related disparities across people in different socioeconomic strata, geographical distribution, sex and ethnic groups. The disparities that will be considered are AA associated: Mental health conditions; healthcare utilisation; and work impact (time off work and unemployment).
The cumulative lifetime risk of AA was estimated at age 80 years (approximate life expectancy in the UK) using survival models, with age as the timescale and accounting for the competing risk of death.
The assessment of any associations with baseline characteristics and the outcomes of interest will be assessed using Cox proportional hazards models (time to event outcomes) and Poisson regression (repeated event outcomes) models.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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London, United Kingdom
- Momentum Data Limited
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged greater than 12 over the study period.
- Registered with the contributing primary care practice for any duration during the study period
Exclusion Criteria:
- People diagnosed with AA before the study period.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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People with Alopecia Areata
Children and adults aged 12+ with new onset Alopecia Areata registered with a contributing General practitioner (GP) practice during the study period.
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Observational analysis of usual care only.
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People without Alopecia Areata
Children and adults aged 12+ without Alopecia Areata registered with a contributing GP practice during the study period.
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Observational analysis of usual care only.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Likelihood of Depressive Episodes
Time Frame: Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant
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Estimated using logistic regression and reported using adjusted odds ratios
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Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant
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Likelihood of Recurrent Major Depressive Disorder
Time Frame: Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant
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Estimated using logistic regression and reported using adjusted odds ratios
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Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant
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Likelihood of Anxiety Disorder
Time Frame: Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant
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Estimated using logistic regression and reported using adjusted odds ratios
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Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Relative Incidence of Primary Care Attendances
Time Frame: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
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Estimated using negative binomial regression and reported as adjusted incidence rate ratio
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Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
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Relative Incidence of Dermatology Referrals
Time Frame: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
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Estimated using Cox proportional hazard regression and reported as Adjusted hazard ratio
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Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
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Relative Incidence Psychological Therapy
Time Frame: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
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Estimated using Cox proportional hazard regression and reported as adjusted hazard ratio
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Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
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Relative Incidence of Unemployment
Time Frame: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
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Unemployment identified by issue of IB113 or ESA113 forms for unemployment.
Relative incidence estimated using Cox proportional hazard regression and reported as Adjusted hazard ratio
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Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
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Relative Incidence of Time Off Work
Time Frame: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
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Time off work identified by recorded issue of Med 3 certificate in primary care.
Relative incidence estimated using Cox proportional hazard regression and reported as Adjusted hazard ratio
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Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Andrew McGovern, MD, Momentum Data
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- p068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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