Atopic DermatitisNCT03559075
Clinical vs. Anecdotal Evidence - Pediatric Atopic Dermatitis
An observational study of Atopic Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2018to 8 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects meeting the following characteristics will be eligible to participate: caregiver of an individual age <1-17, and possessing a working knowledge of English.
Who may be able to join
- Parent/Caregiver of an individual age <1-17 years old
- Subjects with a working knowledge of English
Who cannot join
- Parent/Caregiver of an individual 18 years or older
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Assessing Caregiver's Confidence in the Use of Topical Corticosteroids for a Child's Atopic Dermatitis
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, eczema, children
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. | |
| 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. | |
| 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. | |
| 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. | |
| 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. | |
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey responses on "willingness to treat"
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.
Measured: 1 day
Survey responses on "willingness to treat with doctor's recommended medication"
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start2 Jul 2018
- Primary completion8 Aug 2018
- Study completion8 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stevan Feldman, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559075
- Sponsor's protocol ID
- IRB00051332
- Status last verified
- Sep 2018
- First submitted
- 5 Jun 2018
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26162106
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Caregiver's Confidence in the Use of Topical Corticosteroids for a Child's Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03559075
- Acronym / sponsor ID
- IRB00051332
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, eczema, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects meeting the following characteristics will be eligible to participate: caregiver of an individual age <1-17, and possessing a working knowledge of English.
Key inclusion criteria (2 listed)
- Parent/Caregiver of an individual age <1-17 years old
- Subjects with a working knowledge of English
Key exclusion criteria (1 listed)
- Parent/Caregiver of an individual 18 years or older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survey responses on "willingness to treat"
Time frame: 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"
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Background: PubMed 26162106Buhrmester 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stevan Feldman, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survey responses on "willingness to treat" (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03559075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.