Condition or disease |
---|
Atopic Dermatitis |
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 Type : | Observational |
Actual Enrollment : | 480 participants |
Observational Model: | Case-Only |
Time Perspective: | Cross-Sectional |
Official Title: | Assessing Caregiver's Confidence in the Use of Topical Corticosteroids for a Child's Atopic Dermatitis |
Actual Study Start Date : | July 2, 2018 |
Actual Primary Completion Date : | August 8, 2018 |
Actual Study Completion Date : | August 8, 2018 |
Group/Cohort |
---|
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.
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Wake Forest Baptist Medical Center | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Stevan Feldman, MD | Wake Forest University Health Sciences |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date | June 5, 2018 | ||||
First Posted Date | June 15, 2018 | ||||
Last Update Posted Date | September 27, 2018 | ||||
Actual Study Start Date | July 2, 2018 | ||||
Actual Primary Completion Date | August 8, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
|
||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Clinical vs. Anecdotal Evidence - Pediatric Atopic Dermatitis | ||||
Official Title | Assessing Caregiver's Confidence in the Use of Topical Corticosteroids for a Child's Atopic Dermatitis | ||||
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. |
||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Only Time Perspective: Cross-Sectional |
||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
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. | ||||
Condition | Atopic Dermatitis | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts |
|
||||
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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
480 | ||||
Original Estimated Enrollment | Same as current | ||||
Actual Study Completion Date | August 8, 2018 | ||||
Actual Primary Completion Date | August 8, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender |
|
||||
Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03559075 | ||||
Other Study ID Numbers | IRB00051332 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement |
|
||||
Responsible Party | Wake Forest University Health Sciences | ||||
Study Sponsor | Wake Forest University Health Sciences | ||||
Collaborators | Not Provided | ||||
Investigators |
|
||||
PRS Account | Wake Forest University Health Sciences | ||||
Verification Date | September 2018 |