NCT02713035|TerminatedDMC
Study Stopped
moved to new institution
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Sponsor study identifier
interventional
10
1 country
1
Study Start
March 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2017
Actual (reported)Study Completion
July 2017
Actual (reported)Patients with atopic dermatitis and eczema often struggle with habitual scratching that is not well-controlled even with optimal medical therapy. Our goal is to create a behavioral intervention to help children with eczema reduce scratching. The investigators hope that the intervention will improve clinical outcomes and quality of life, as well as provide an easily implemented way for clinicians to educate patients and parents about behavioral modification techniques.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2016
Date type not reportedThis date has not been verified as actual or estimated.
March 9, 2016
Actual (reported)March 18, 2016
Actual (reported)July 2017
Actual (reported)July 2017
Actual (reported)SCORAD - Scoring Atopic Dermatitis - change at follow-up 1-4 months later
widely-used, validated tool for quantifying the extent and severity of eczema. The form is completed by the physician evaluating the patient in the office, and we will plan to complete this measure at both the initial and follow-up visit.
Baseline and Follow up visit - change at follow-up 1-4 months later
Index of Itching Intensity and Scratching Activity - change at follow-up 1-4 months later
5-item self-report questionnaire that assesses current and past week intensity of itching, frequency of scratching behaviors, and excoriations occurring as a result of scratching. This measure will be completed at both the initial and follow-up visit.
Baseline and Follow up visit - change at follow-up 1-4 months later
Acceptability and Feasibility Questionnaire- to assess at follow-up 1-4 months later
The 11-item questionnaire obtains self-report feedback from the parent with regard to: acceptability of the pamphlet, ease of readability, and use of the pamphlet.
the follow-up visit in 1-4 months to participants who received the self-help intervention
Children's Dermatology Quality of Life Index
Baseline and Follow up visit - change at follow-up 1-4 months later
Preschool Anxiety Scale - Parent Report (PAS) or the Spence Children's Anxiety Scale-Parent Report (SCAS) - depending on patient age
Baseline and Follow up visit- change at follow-up 1-4 months later
Child Anxiety Sensitivity Index - Parent Version
Baseline and Follow up visit- change at follow-up 1-4 months later
Receive standard medical therapy for eczema
Receive standard medical therapy for eczema plus behavioral self help intervention
For participants randomized to receive the treatment, the self-help intervention will be briefly described by a member of the clinical staff, and a brief pamphlet will be distributed to the parent or guardian at the end of the visit. The pamphlet describes behavioral strategies for coping with and reducing scratching behaviors. Participants randomly selected to not receive the treatment will not receive the pamphlet at the end of the visit.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pavilion Dermatology Suite K
Jackson, Mississippi, 39216, United States
Stephanie K Jacks, MD
assistant professor
10 participants (actual enrollment reported by the registry).
First Submitted
March 9, 2016
First Posted
March 18, 2016
Study Start
March 2016
Date type not reportedThis date has not been verified as actual or estimated.
Cooling Pillow for Atopic Dermatitis
Contact the study team to confirm eligibility.
Primary Completion
July 2017
Actual (reported)Study Completion
July 2017
Actual (reported)Last Updated
February 19, 2018
Record last verified: 2018-02
All data will be reviewed by a member of the research team the same week it is collected in order to ensure completion and clarity. The research team will maintain an updated data tracking form indicating when participant data are collected, entered, and verified, as well as any corrections that are needed. The PI, clinical staff, and trained bachelors- or Master-level staff will collect the data, and will thus have access to participant identities. However, the investigators will safeguard against breaches of confidentiality by coding participant data by ID number rather than by name, and by keeping information linking these ID numbers to specific individuals in a locked file cabinet accessible only to project staff. Further, individuals will not be identified by name (nor will any identifying information be offered) when results from data are disseminated.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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