Healthcare Disparities in Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

Healthcare Disparities in Alopecia Areata: UK Population-based Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05727306
• Other study ID #: p068
• Status: Active, not recruiting
• Start date: October 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2023
• Source: Momentum Data
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30902
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Gender: All
• Age group: 12 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Other:
• No intervention
Observational analysis of usual care only.

Locations

Country	Name	City	State
United Kingdom	Momentum Data Limited	London

Sponsors (3)

Lead Sponsor	Collaborator
Momentum Data	Pfizer, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total disease burden	Disease burden of Alopecia Areata (AA) measured using cumulative lifetime incidence against age.	Measured over 10 years - 2009 - 2018 inclusive.
Secondary	Incidence of mental health conditions within patients with AA	Describe any disparities in AA related mental health conditions measured by time to first mental health diagnosis	2 years
Secondary	Primary care attendance	Describe any disparities in AA healthcare utilisation measured by the number of primary care visits.	2 years
Secondary	Dermatology referrals	Describe any disparities in AA healthcare utilisation measured by the number of dermatology referrals,	2 years
Secondary	Psychological therapy	Describe any disparities in AA healthcare utilisation measured by the number of referrals for psychological therapy.	2 years
Secondary	Psychiatric reviews	Describe any disparities in AA healthcare utilisation measured by the number of referrals to psychiatric review.	2 years
Secondary	Unemployment	Describe any disparities in work-related impact measured by time to first recorded unemployment event.	2 years
Secondary	Time off work	Describe any disparities in work-related impact measured by time to first recorded time off work sickness event.	2 years