Clinical trial NCT05727306: Healthcare Disparities in Alopecia Areata
Official title: Healthcare Disparities in Alopecia Areata: UK Population-based Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alopecia Areata
Lead sponsor: Momentum Data
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
name: University of Oxford
First posted: 2023-02-14
Enrollment: 4052231
Sex: ALL
Minimum age (years): 12
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals with new onset AA during the study period defined by the presence of at least one disease specific diagnostic code will be eligible for inlcusion in the AA cohort. Controls will be matched people without AA matched on age, sex, geography, ethnicity, socioeconomic status.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Likelihood of Depressive Episodes
timeFrame: Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant
measure: Likelihood of Recurrent Major Depressive Disorder
timeFrame: Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant
measure: Likelihood of Anxiety Disorder
timeFrame: Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant
Secondary outcomes:
measure: Relative Incidence of Primary Care Attendances
timeFrame: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
measure: Relative Incidence of Dermatology Referrals
timeFrame: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
measure: Relative Incidence Psychological Therapy
timeFrame: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
measure: Relative Incidence of Unemployment
timeFrame: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
measure: Relative Incidence of Time Off Work
timeFrame: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Momentum Data Limited
Study officials:
affiliation: Momentum Data
name: Andrew McGovern, MD
role: STUDY_DIRECTOR
References: