Investigating Healthcare Disparities in Vitiligo

Vitiligo Clinical Trial

Official title:

Healthcare Disparities in Vitiligo: a Population-based Cohort Study in the UK

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06097494
• Other study ID #: P084
• Status: Active, not recruiting
• Start date: July 20, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: March 2024
• Source: Momentum Data
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Vitiligo is an acquired, non contagious skin disorder characterised by depigmented patches of skin that may appear in a localised or very generalised distribution, and affecting 0.5-2.0% of the global population.There are however, limited population-based studies on the burden of vitiligo and disparities across people of different ethnicities and deprivation.

The overall purpose of this study is to provide an estimate of the lifetime risk of vitiligo in the population overall and by sociodemographic subgroups. Moreover, to do a subgroup analysis in the vitiligo population to identify health-related disparities across people in different sex, age, deprivation and ethnicity. A detailed understanding of the burden of disease in different sociodemographic groups is vital to plan resource provision.

Description:

This study will provide estimate of the cumulative lifetime risk of vitiligo in the population overall, and by important sociodemographic groups, including age, sex, ethnicity and deprivation, which will prevalent key data to show the relative burden of vitiligo across the aforementioned groups. These approaches allow creation of cumulative lifetime risk plots which provide an excellent and accessible way to display the relative disease burden across groups.

The cumulative lifetime risk of vitiligo will be estimated at age 80 years (approximate lifetime expectancy in the UK) using survival models, with age as the timescale and accounting for competing risk of death.

This study will also perform a subgroup analysis in the vitiligo population to identify health-related disparities across people in different deprivation, sex and ethnic groups. The disparities that will be considered are: Mental health conditions; healthcare utilisation; and work impact (time off work and unemployment),

The assessment of any associations with baseline characteristics and the outcome of interest will be used using Cox proportional hazards models (time to event outcomes) and generalised linear models.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39374
• Est. completion date: November 15, 2024
• Est. primary completion date: September 15, 2024
• Gender: All
• Age group: N/A to 95 Years

Eligibility

Inclusion Criteria:

• The cohort for the endpoint analysis will consist of all adults and adolescents (aged 13+) contributing to OPCRD during the study period (2004-2020).

• The cohort for the lifetime risk analysis will consist of all people contributing to OPCRD during the study period.

• The vitiligo cohort consists of people newly diagnosed with vitiligo at any point during the study period.

Exclusion Criteria:

• People with the alternative non-vitiligo diagnoses (other hypopigmenting conditions).

• People with vitiligo diagnosis within 6 months of practice registration.

• People without vitiligo with less than 1 year of follow up within the dataset.

• People over the age of 95 (for those reaching age 95 during the follow up period follow up was censored at age 95).

• People who have opted out of record sharing.

Related Conditions & MeSH terms

• Vitiligo

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Momentum Data Limited	London

Sponsors (2)

Lead Sponsor	Collaborator
Momentum Data	Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total disease burden	Disease burden of Vitiligo measured using cumulative lifetime incidence against age.	Measured over 17 years - 2004 - 2020 inclusive
Secondary	Incidence of mental health conditions within patients with Vitiligo	Describe any disparities in mental health conditions within Vitiligo patients.	2 years
Secondary	Prevalence of mental health conditions within patients with Vitiligo	Describe any disparities in mental health conditions within Vitiligo patients.	Registration until index date (study start)
Secondary	Primary care encounters	Describe any disparities healthcare utilisation measured by the number of primary care visits.	2 years
Secondary	Dermatology referrals	Describe any disparities in healthcare utilisation measured by time to first recorded dermatology referral event.	2 years
Secondary	Mental health referrals	Describe any disparities in healthcare utilisation measured by time to first recorded mental health referral event.	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 event.	2 years