Healthcare Disparities in Alopecia Areata

Sponsor
Momentum Data (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05727306
Collaborator
Pfizer (Industry), University of Oxford (Other)
30,902
1
10
3094

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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 Design

Study Type:
Observational
Anticipated Enrollment :
30902 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Healthcare Disparities in Alopecia Areata: UK Population-based Cohort Study
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
People with Alopecia Areata

Children and adults aged 12+ with new onset Alopecia Areata registered with a contributing GP practice during the study period.

Other: No intervention
Observational analysis of usual care only.

People without Alopecia Areata

Children and adults aged 12+ without Alopecia Areata registered with a contributing practice during the study period.

Other: No intervention
Observational analysis of usual care only.

Outcome Measures

Primary Outcome Measures

  1. Total disease burden [Measured over 10 years - 2009 - 2018 inclusive.]

    Disease burden of Alopecia Areata (AA) measured using cummulative lifetime incidence against age.

Secondary Outcome Measures

  1. Incidence of mental health conditions within patients with AA [2 years]

    Describe any disparities in AA related mental health conditions measured by time to first mental health diagnosis

  2. Primary care attendance [2 years]

    Describe any disparities in AA healthcare utilisation measured by the number of primary care visits.

  3. Dermatology referrals [2 years]

    Describe any disparities in AA healthcare utilisation measured by the number of dermatology referrals,

  4. Psychological therapy [2 years]

    Describe any disparities in AA healthcare utilisation measured by the number of referrals for psychological therapy.

  5. Psychiatric reviews [2 years]

    Describe any disparities in AA healthcare utilisation measured by the number of referrals to psychiatric review.

  6. Unemployment [2 years]

    Describe any disparities in work-related impact measured by time to first recorded unemployment event.

  7. Time off work [2 years]

    Describe any disparities in work-related impact measured by time to first recorded time off work sickness event.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 95 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Momentum Data Limited London United Kingdom

Sponsors and Collaborators

  • Momentum Data
  • Pfizer
  • University of Oxford

Investigators

  • Study Director: Andrew McGovern, MD, Momentum Data

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Momentum Data
ClinicalTrials.gov Identifier:
NCT05727306
Other Study ID Numbers:
  • p068
First Posted:
Feb 14, 2023
Last Update Posted:
Feb 14, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2023