Clinical vs. Anecdotal Evidence - Pediatric Atopic Dermatitis

NCT ID: NCT03559075

Last Updated: 2022-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-02

Study Completion Date

2018-08-08

Brief Summary

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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

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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.

Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1

Participants will be randomized into group 1 to be queried about their comfort with medication for treating their child's atopic dermatitis after hearing varying amounts of information about the treatment.

No interventions assigned to this group

Group 2

Participants will be randomized into group 2 to be queried about their comfort with medication for treating their child's atopic dermatitis after hearing varying amounts of information about the treatment.

No interventions assigned to this group

Group 3

Participants will be randomized into group 3 to be queried about their comfort with medication for treating their child's atopic dermatitis after hearing varying amounts of information about the treatment.

No interventions assigned to this group

Group 4

Participants will be randomized into group 4 to be queried about their comfort with a topical steroid for treating their child's atopic dermatitis after hearing varying amounts of information about the treatment.

No interventions assigned to this group

Group 5

Participants will be randomized into group 5 to be queried about their comfort with a topical steroid for treating their child's atopic dermatitis after hearing varying amounts of information about the treatment.

No interventions assigned to this group

Group 6

Participants will be randomized into group 6 to be queried about their comfort with a topical steroid for treating their child's atopic dermatitis after hearing varying amounts of information about the treatment.

No interventions assigned to this group

Group 7

Participants will be randomized into group 7 to be queried about their comfort with medication for treating their child's atopic dermatitis after hearing varying amounts of information about the treatment.

No interventions assigned to this group

Group 8

Participants will be randomized into group 8 to be queried about their comfort with medication for treating their child's atopic dermatitis after hearing varying amounts of information about the treatment.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Parent/Caregiver of an individual age \<1-17 years old
* Subjects with a working knowledge of English

Exclusion Criteria

* Parent/Caregiver of an individual 18 years or older
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stevan Feldman, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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Buhrmester M, Kwang T, Gosling SD. Amazon's Mechanical Turk: A New Source of Inexpensive, Yet High-Quality, Data? Perspect Psychol Sci. 2011 Jan;6(1):3-5. doi: 10.1177/1745691610393980. Epub 2011 Feb 3.

Reference Type BACKGROUND
PMID: 26162106 (View on PubMed)

Other Identifiers

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IRB00051332

Identifier Type: -

Identifier Source: org_study_id

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