Investigating Healthcare Disparities in Vitiligo

Sponsor
Momentum Data (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT06097494
Collaborator
Pfizer (Industry)
39,374
1
15.9
2476.1

Study Details

Study Description

Brief 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.

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

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
39374 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Healthcare Disparities in Vitiligo: a Population-based Cohort Study in the UK
Actual Study Start Date :
Jul 20, 2023
Anticipated Primary Completion Date :
Sep 15, 2024
Anticipated Study Completion Date :
Nov 15, 2024

Arms and Interventions

Arm Intervention/Treatment
People with Vitiligo

Children and adults with new onset Vitiligo registered with OPCRD during the study period.

Other: No intervention
Observational analysis of usual care only.

People without Vitiligo

Children and adults without Vitiligo registered with OPCRD during the study period

Other: No intervention
Observational analysis of usual care only.

Outcome Measures

Primary Outcome Measures

  1. Total disease burden [Measured over 17 years - 2004 - 2020 inclusive]

    Disease burden of Vitiligo measured using cumulative lifetime incidence against age.

Secondary Outcome Measures

  1. Incidence and prevalence of mental health conditions within patients with Vitiligo [2 years]

    Describe any disparities in mental health conditions within Vitiligo patients.

  2. Primary care encounters [2 years]

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

  3. Dermatology referrals [2 years]

    Describe any disparities in healthcare utilisation measured by time to first recorded dermatology referral event.

  4. Mental health referrals [2 years]

    Describe any disparities in healthcare utilisation measured by time to first recorded mental health referral event.

  5. Unemployment [2 years]

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

  6. Time off work [2 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 95 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Momentum Data
  • Pfizer

Investigators

  • Study Director: Andrew McGovern, MD, Momentum Data

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Momentum Data
ClinicalTrials.gov Identifier:
NCT06097494
Other Study ID Numbers:
  • P084
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Aug 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 Oct 24, 2023