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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04239521
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 28, 2020
Sponsor:
Collaborators:
Pfizer
University of Surrey
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Alopecia Areata Depressive Episode Recurrent Depressive Disorder Anxiety Disorders Atopic Dermatitis Allergic Rhinitis Asthma Crohn Disease Ulcerative Colitis Pernicious Anemia Type 1 Diabetes Hashimoto Thyroiditis Graves Disease Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis Systemic Lupus Erythematosus Polymyalgia Rheumatica Sjogren's Syndrome Psoriasis Vitiligo Multiple Sclerosis Celiac Disease Other: Exposure of interest (studies 2 & 3).

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.

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions in Alopecia Areata
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020


Group/Cohort Intervention/treatment
Cases
Patients with a confirmed diagnosis of Alopecia areata within the study period will be included as cases for analysis.
Other: Exposure of interest (studies 2 & 3).
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

Controls
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.
Other: Exposure of interest (studies 2 & 3).
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




Primary Outcome Measures :
  1. Study 1: The incidence of Alopecia Areata [ Time Frame: Overall during 2009-2018 inclusive ]
    The incidence of Alopecia areata within the study cohort during the study period

  2. Study 1: The incidence of Alopecia Areata stratified by sociodemographic factors [ Time Frame: Overall during 2009-2018 inclusive ]
    This will comprise of the incidence of Alopecia Areata over the study period, by age group, gender, ethnicity, and Social Economic Status.

  3. Study 1:The annual rate of primary care visits for people with Alopecia Areata. [ Time Frame: Within one year of diagnosis of Alopecia Areata ]
    The annual rate of visits to primary care for any reason within one year of diagnosis.

  4. Study 1: The percent of people reviewed in secondary care dermatology services within one year of diagnosis of Alopecia Areata [ Time Frame: Within one year of diagnosis of Alopecia Areata ]
  5. Study 2: The prevalence of common mental health conditions in adult patients diagnosed with Alopecia Areata at the time of diagnosis [ Time Frame: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive ]
    Prevalence of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients diagnosed with Alopecia Areata in a contemporary real-world population compared with matched controls.

  6. Study 2: Describe the incidence of common mental health conditions in adult patients with Alopecia Areata [ Time Frame: Within two years of diagnosis of Alopecia Areata ]
    Incidence of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

  7. Study 2: Describe the mental health medication treatment burden of adult patients diagnosed with Alopecia Areata. [ Time Frame: Within two years of diagnosis of Alopecia Areata ]
    This will comprise of the number of medications used to treat mental health conditions in patients diagnoses with Alopecia Areata. Antidepressant medication classes to be examined comprise; selective serotonin reuptake inhibitors and related medications (serotonin and norepinephrine reuptake inhibitors (SNRIs)), tricyclic antidepressants and related medications (tetracyclic antidepressant), and monoamine oxidase inhibitors. Anxiolytic medications to be examined comprise all benzodiazepines and other related medications indicated for use in anxiety states.

  8. Study 2: Number of patients diagnosed with Alopecia Areata receiving mental health psychological intervention. [ Time Frame: Within two years of diagnosis of Alopecia Areata ]
    This will comprise of the number of psychological interventions used to treat mental health conditions in patients diagnoses with Alopecia Areata. Psychological interventions comprise of counselling, Cognitive Behavioural Therapy, and psychotherapy.

  9. Study 3: Describe the prevalence of atopic and autoimmune conditions in adult patients diagnosed with Alopecia Areata at the time of diagnosis [ Time Frame: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive ]
    Prevalence of atopic and autoimmune conditions in adult patients diagnosed with Alopecia Areata in a contemporary real-world population at diagnosis compared with matched controls.

  10. Study 3: Describe the incidence of atopic and autoimmune conditions in adult patients with Alopecia Areata. [ Time Frame: Within five years of Alopecia Areata diagnosis ]
    Incidence of atopic and autoimmune conditions in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.


Secondary Outcome Measures :
  1. Study 1: Adjusted incidence rate ratios of Alopecia Areata within England by geographic region. [ Time Frame: Overall during 2009-2018 inclusive ]
    By region across England.

  2. 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. [ Time Frame: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive ]
    By age group, gender, ethnicity, and Social Economic Status.

  3. Study 2: Describe the burden of 'sick days' in adult patients diagnosed with Alopecia Areata relating to mental health conditions. [ Time Frame: Within one year of diagnosis of Alopecia Areata ]
    Sick days will be indicated by the issuing of Med 3 certification from primary care (Statement of Fitness for Work) certification.

  4. Study 2: Describe the prevalence of unemployment in adult patients diagnosed with Alopecia Areata. [ Time Frame: Within one year of diagnosis of Alopecia Areata ]
    Unemployment will be identified using Read codes relating to unemployment recorded in the clinical record or the issuing of an Incapacity Benefit (IB113) or Employment and Support Allowance (ESA113) form.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
These studies will use routinely collected and collated data from the Royal College of General Practitioners Research and Surveillance Centre database to provide a broadly representative sample of the population of England.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239521


Contacts
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Contact: Andrew McGovern, MD +44 7531 221970 andy.mcgovern@momentumdata.co.uk
Contact: John Dennis, PhD +44 7734 940921 john.dennis@momentumdata.co.uk

Locations
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United Kingdom
Momentum Data Ltd
London, United Kingdom, WC1X 8QT
Sponsors and Collaborators
Momentum Data
Pfizer
University of Surrey
Investigators
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Study Director: Andrew McGovern, MD Momentum Data

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Responsible Party: Momentum Data
ClinicalTrials.gov Identifier: NCT04239521    
Other Study ID Numbers: P005
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual patient data is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Momentum Data:
Alopecia areata
Common mental health conditions
Depression
Anxiety
Autoimmune disease
Atopic conditions
Epidemiology
Incidence
Prevalence
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Psoriatic
Spondylitis, Ankylosing
Sjogren's Syndrome
Polymyalgia Rheumatica
Crohn Disease
Celiac Disease
Multiple Sclerosis
Giant Cell Arteritis
Graves Disease
Anemia, Pernicious
Dermatitis
Lupus Erythematosus, Systemic
Alopecia
Alopecia Areata
Vitiligo
Thyroiditis
Hashimoto Disease
Autoimmune Diseases
Disease
Depressive Disorder
Anxiety Disorders
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Immune System Diseases