MedPath

Clinical vs. Anecdotal Evidence - Pediatric Atopic Dermatitis

Completed
Conditions
Atopic Dermatitis
Registration Number
NCT03559075
Lead Sponsor
Wake Forest University Health Sciences
Brief Summary

In dermatology, topical anti-inflammatory medications, such as corticosteroids, are the mainstay treatment of managing patients with atopic dermatitis. However, caregivers are often apprehensive about choosing a topical steroid for a variety of reasons. Many caregivers are not aware that clinical trial evidence for these medications exist, and instead may rely on anecdotal evidence in choosing to take these medications. Because fear of the drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. The goal of the study is to learn whether caregivers are more confident in treating a child's atopic dermatitis after being presented with varying amounts of information.

Detailed Description

Atopic dermatitis is the most common chronic, inflammatory dermatologic condition in young children, with a prevalence approaching 25% in some countries. Topical corticosteroids, the mainstay treatment in managing atopic dermatitis, generally function to decrease inflammation and suppress the immune response. Topical corticosteroids are grouped into distinct categories based on their degree of potency, including very high potency (Clobetasol propionate), high potency (triamcinolone acetonide), medium potency (fluocinonide), and low potency agents (desonide).

Caregivers are often apprehensive about choosing a topical steroid for a variety of reasons. These include hearing negative information about the drug from friends or family, being nervous about treatment, or seeing the drug or its side effects negatively portrayed in the media. Many parents/caregivers are not aware that clinical trial evidence for these medications exist, and instead may rely on anecdotal evidence in choosing to take these medications.

Because fear of the drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. By understanding what kind of information will allow caregivers to be confident in their decision to use a topical corticosteroid, dermatologists may improve treatment adherence and outcomes. The goal of the study is to learn whether caregivers are more confident in treating a child's atopic dermatitis after being presented with varying amounts of information about the treatment.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
480
Inclusion Criteria
  • Parent/Caregiver of an individual age <1-17 years old
  • Subjects with a working knowledge of English
Read More
Exclusion Criteria
  • Parent/Caregiver of an individual 18 years or older
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Survey responses on "willingness to treat"1 day

Groups 1, 2, and 3 will be compared to assess whether caregivers are more willing to use a medication to manage their child's atopic dermatitis if presented with clinical trial evidence, anecdotal evidence, or both. Groups 4, 5, and 6 will be compared to assess whether caregivers are more willing to use a topical steroid to manage their child's atopic dermatitis if presented with clinical trial evidence, anecdotal evidence, or both. The results from groups 1, 2, and 3 will then be compared to the results from groups 4, 5, and 6 to assess whether the use of the word "steroid" impacts the caregiver's willingness to treat.

Survey responses on "willingness to treat with doctor's recommended medication"1 day

Groups 7 and 8 will be compared to assess how caregiver's willingness to treat with a doctor's recommended medication is impacted by the exclusion of anecdotal evidence, clinical trial evidence, or both.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center

🇺🇸

Winston-Salem, North Carolina, United States

© Copyright 2025. All Rights Reserved by MedPath