The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions in Alopecia Areata

The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions in Alopecia Areata

Sponsors

Lead Sponsor: Momentum Data

Collaborator: Pfizer
University of Surrey

Source Momentum Data
Brief Summary

This study series consists of three related studies and aims to explore and describe many important elements of Alopecia areata over three key areas: (i) the current epidemiology of Alopecia areata, (ii) the prevalence and incidence of psychiatric co-morbidities in people with Alopecia areata and (iii) the prevalence and incidence of autoimmune and atopic conditions in people with Alopecia areata.

Detailed Description

The overall purpose of the first study (Study 1) is to describe the epidemiology of Alopecia areata (AA) and to assess the current level of primary care service utilisation and management patterns associated with patients diagnosed with AA. The overall purpose of the second study (study 2) is to assess the prevalence and incidence of mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients diagnosed with AA relative to a control population of patients without a diagnosis of AA. In addition, the study will determine both the treatment, 'sick day' and unemployment burden. Treatment burden comprises that of medications and psychological interventions used to treat mental health conditions in adult patients diagnosed with Alopecia areata. The overall purpose of the third study (Study 3) is to assess the prevalence and incidence of atopic and autoimmune conditions in adult patients diagnosed with AA relative to a control population of patients without AA.

Overall Status Not yet recruiting
Start Date March 2020
Completion Date March 2020
Primary Completion Date March 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Study 1: The incidence of Alopecia Areata Overall during 2009-2018 inclusive
Study 1: The incidence of Alopecia Areata stratified by sociodemographic factors Overall during 2009-2018 inclusive
Study 1:The annual rate of primary care visits for people with Alopecia Areata. Within one year of diagnosis of Alopecia Areata
Study 1: The percent of people reviewed in secondary care dermatology services within one year of diagnosis of Alopecia Areata Within one year of diagnosis of Alopecia Areata
Study 2: The prevalence of common mental health conditions in adult patients diagnosed with Alopecia Areata at the time of diagnosis At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
Study 2: Describe the incidence of common mental health conditions in adult patients with Alopecia Areata Within two years of diagnosis of Alopecia Areata
Study 2: Describe the mental health medication treatment burden of adult patients diagnosed with Alopecia Areata. Within two years of diagnosis of Alopecia Areata
Study 2: Number of patients diagnosed with Alopecia Areata receiving mental health psychological intervention. Within two years of diagnosis of Alopecia Areata
Study 3: Describe the prevalence of atopic and autoimmune conditions in adult patients diagnosed with Alopecia Areata at the time of diagnosis At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
Study 3: Describe the incidence of atopic and autoimmune conditions in adult patients with Alopecia Areata. Within five years of Alopecia Areata diagnosis
Secondary Outcome
Measure Time Frame
Study 1: Adjusted incidence rate ratios of Alopecia Areata within England by geographic region. Overall during 2009-2018 inclusive
Study 2: Prevalence (percentage) of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder), by socio-demographic factors, in adult patients diagnosed with Alopecia Areata. At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
Study 2: Describe the burden of 'sick days' in adult patients diagnosed with Alopecia Areata relating to mental health conditions. Within one year of diagnosis of Alopecia Areata
Study 2: Describe the prevalence of unemployment in adult patients diagnosed with Alopecia Areata. Within one year of diagnosis of Alopecia Areata
Enrollment 4000
Condition
Intervention

Intervention Type: Other

Intervention Name: Exposure of interest (studies 2 & 3).

Description: Common mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder Atopic conditions consist of Atopic dermatitis, allergic rhinitis, asthma Autoimmune conditions consist of Crohn's disease, ulcerative colitis, Coeliac disease, Pernicious anaemia, Type 1 diabetes, Hashimoto's thyroiditis, Grave's disease, Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Systemic lupus erythematosus, polymyalgia rheumatica, Sjögren's syndrome, Psoriasis, vitiligo, Multiple sclerosis

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria: - Patients contributing to Royal College of General Practitioners Research and Surveillance Centre(RCGP RCS) primary care database between January 1, 2009 and December 31, 2018, will be eligible for inclusion. - Only patients aged ≥18 will be eligible for studies 2 and 3. - Only patients aged ≥ 18 and ≤ 65 will be included in the unemployment and sick day analysis (study 2) Exclusion Criteria: - People with the alternative non-AA diagnoses. - People with AA diagnosis within 6 months of registration. - People with less than 1 year of follow up available

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Overall Official
Last Name Role Affiliation
Andrew McGovern, MD Study Director Momentum Data
Overall Contact

Last Name: Andrew McGovern, MD

Phone: +44 7531 221970

Email: [email protected]

Location
Facility: Momentum Data Ltd
Location Countries

United Kingdom

Verification Date

January 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Cases

Description: Patients with a confirmed diagnosis of Alopecia areata within the study period will be included as cases for analysis.

Label: Controls

Description: The control cohorts will be defined by matching cases with patients who have never been diagnosed with Alopecia areata either prior to or during the study period, by age and sex, at General Practice practice level.

Patient Data Yes
Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov