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Trial record 1 of 1 for:    NCT03823794
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Trends in the Epidemiology and Treatment of Atopic Dermatitis in the United Kingdom (UK)

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ClinicalTrials.gov Identifier: NCT03823794
Recruitment Status : Active, not recruiting
First Posted : January 30, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
Pfizer
Royal College of General Practitioners Research and Surveillance Centre
Information provided by (Responsible Party):
Momentum Data

Tracking Information
First Submitted Date January 17, 2019
First Posted Date January 30, 2019
Last Update Posted Date January 18, 2020
Actual Study Start Date February 1, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 28, 2019)
  • The incidence of atopic dermatitis [ Time Frame: Measure will be reported annually by year from 2008-2018 ]
    Incidence of atopic dermatitis reported by predefined sociodemographic factors
  • The prevalence of atopic dermatitis [ Time Frame: Measure will be reported annually by year from 2008-2018 ]
    Prevalence of atopic dermatitis reported by predefined sociodemographic factors
  • The prevalence of diagnosed co-morbidities in people with and without atopic dermatitis [ Time Frame: Prevelence reported annually by year from 2008-2018 ]
    Co-morbidities to be reported comprise; asthma, allergic rhinitis (hay fever), depression, anxiety, attention deficit hyperactivity disorder (ADHD), cardiovascular diseases (CVD; comprising myocardial infarction, angina, heart failure, atrial fibrillation, and stroke), rheumatoid arthritis, inflammatory bowel disease (ulcerative colitis and Crohn's disease), type 1 and type 2 diabetes, multiple sclerosis (MS) and coeliac disease. The presence of these co-morbidities will be identified from existing primary care records.
  • Annual rates of service utilisation (number of primary and secondary care visits) in people with atopic dermatitis [ Time Frame: Measures will be reported annually by year from 2008-2018 ]
    Service utilisation events comprise; primary care visits related to atopic dermatitis (prescription of treatment or coding of AD related problem), specialist care referrals to dermatology, and emergency admissions to dermatology. These events will also be reported separately.
  • Annual prescription rates for atopic dermatitis related treatments [ Time Frame: Measures will be reported annually by year from 2008-2018 ]
    Treatment rates will be reported separately and comprise: emollients and soap substitutes, topical steroids, topical antimicrobial therapies, combination topical therapies, topical calcineurin inhibitors, and oral immune modulating treatments, and phototherapy.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 28, 2019)
  • Time to occurrence of moderate atopic dermatitis [ Time Frame: Models will be devised using data from 2008-2018 ]
    The impact of sociodemographic predictors on time to first occurrence of moderate atopic dermatitis
  • Time to occurrence of severe atopic dermatitis [ Time Frame: Models will be devised using data from 2008-2018 ]
    The impact of sociodemographic predictors on time to first occurrence of severe atopic dermatitis
  • Time to recurrence of active atopic dermatitis [ Time Frame: Models will be devised using data from 2008-2018 ]
    The impact of sociodemographic predictors on time to first recurrence of atopic dermatitis in those with inactive disease
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Trends in the Epidemiology and Treatment of Atopic Dermatitis in the United Kingdom (UK)
Official Title The Epidemiology of Atopic Dermatitis, Associated Comorbidities, and Treatment Patterns in the United Kingdom (UK)
Brief Summary

Atopic dermatitis, commonly called eczema, is one of the most frequently occurring skin conditions. It is estimated to affect around one fifth of children in developed countries and is also becoming increasingly common in less developed countries. Exact estimates of how common eczema is, vary considerably and there has not been an in-depth analysis of the number of people with eczema in the UK. It is also unclear which groups of people are most affected and which treatment options are being used.

Most people with eczema are managed by their general practitioner (GP) with only a few people requiring specialist care. GP records therefore provide an excellent opportunity to explore how common eczema is and which treatments are being used currently. This study aims to provide accurate estimates of the number of people with current eczema (prevalence), number developing new onset eczema (incidence), and the pattern of common comorbidities in people with eczema. It also aims describe current treatment patterns by age groups and other factors. It also will look back over the last decade to identify how the number of people with eczema and treatments changing over time. The study will also explore patterns in the people most commonly affected and in the treatments used.

Detailed Description

Objective

This study aims to calculate current and accurate prevalence and incidence estimates for atopic dermatitis (AD) by age group and sociodemographic factors. It also aims to describe the burden of comorbidity in AD with a focus on atopic and mental health conditions. The study also aims to describe the health care resource utilisation of this cohort in terms of prescription use, primary care appointments, and specialist referrals.

Method This study will define AD cases using a previously validated algorithm for case identification use clinical codes form primary care in the UK (Read codes). The study will analyse the population prevalence and incidence of AD using this definition over a 10-year period (2008-2018). Within this population the prevalence of autoimmune conditions (rheumatoid arthritis, inflammatory bowel disease, coeliac disease, type 1 diabetes, and multiple sclerosis) will be reported and compared with a cohort of individuals without a diagnosis of AD, matched by age and sex at GP practice level. In the same cohort, the annual use of topical and oral medications used for the treatment of AD, primary care appointments, and specialist referrals, overall and stratified by sociodemographic factors will also be reported.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults and children with atopic dermatitis identified from routinely collected healthcare records using a validated algorithm.
Condition
  • Atopic Dermatitis Eczema
  • Atopic Dermatitis
  • Eczema
Intervention Other: No intervention
Observational analysis of usual care only
Study Groups/Cohorts
  • Prevalent case of atopic dermatitis
    People with atopic dermatitis meeting the inclusion criteria and registered with one of the study practices for one or more years during the study period.
    Intervention: Other: No intervention
  • Controls
    Age, gender and primary care practice-matched controls without a diagnosis of atopic dermatitis or another exclusion condition (psoriasis, photodermatitis, or ichthyosis) and registered with one of the study practices for one or more years during the study period.
    Intervention: Other: No intervention
Publications * de Lusignan S, Alexander H, Broderick C, Dennis J, McGovern A, Feeney C, Flohr C. Epidemiology and management of atopic dermatitis in England: an observational cohort study protocol. BMJ Open. 2020 Sep 16;10(9):e037518. doi: 10.1136/bmjopen-2020-037518.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: November 18, 2019)
411931
Original Estimated Enrollment
 (submitted: January 28, 2019)
200000
Estimated Study Completion Date June 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All paediatric and adult patients registered with an Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) contributing GP practice during the study period (2008-2018) and with at least one year of follow-up.

Exclusion Criteria:

  • The presence of psoriasis, photodermatitis, or ichthyosis
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03823794
Other Study ID Numbers P002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: All individual patient data (IPD) can be made available to bone fide researchers subject to appropriate checks and approvals made by Momentum Data, the RCGP RSC, and the University of Surrey and subject to the completion of information governance training.
Supporting Materials: Study Protocol
Time Frame: There is no pre-specified time-frame for data availability; this will be considered on an individual basis for each request.
Access Criteria: As above
Responsible Party Momentum Data
Study Sponsor Momentum Data
Collaborators
  • Pfizer
  • Royal College of General Practitioners Research and Surveillance Centre
Investigators Not Provided
PRS Account Momentum Data
Verification Date January 2020