The Effectiveness of Tailored Messages on the Usage of Emollient in Patients With Atopic Dermatitis

Study Overview
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Brief Summary
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Atopic dermatitis is the most common chronic inflammatory skin disease in children and severely affects quality of life (QoL) of patients and their parents. The application of topical medications and emollient is the mainstay of the treatment, but complexity of the treatment and lack of self-care knowledge cause poor adherence, leading to therapeutic failure. Adequate education about the chronic disease and its treatment was known to improve the treatment adherence. There are a variety forms like generalized information leaflets and video clips for imparting information to patients and individualized tailoring education was considered more effective way to improve patients' adherence. The aim of this study is to determine the efficacy of tailored education in dermatology area, especially the emollient usage in patients with atopic dermatitis.

Official Title
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The Effectiveness of Tailored Messages on the Usage of Emollient in Patients With Atopic Dermatitis: A Pilot Study

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Behavioral: Tailored leaflet group
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A parent of 0-5 year old children with mild to moderate atopic dermatitis 20 years of age or older Apply emollient for themselves to their children with atopic dermatitis Exclusion Criteria: Parents of children with severe atopic dermatitis or showing signs of acute infection (Oozing, vesicles, edema, redness or pain)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tailored leaflet group<br>Participants (parents of children with atopic dermatitis) receive a tailored leaflet about the detailed amount of emollients as well as general information about use of emollients. | Behavioral: Tailored leaflet group<br>* Parents in intervention group will receive an patient education leaflet and watch an educational video about lifestyle recommendations, and the use of emollients. In addition to general information, parents in intervention group will also receive the tailored leaflet including the estimated amount of emollients based on the body surface area.<br>* Other names: Tailored leaflet about the adequate use of emollient;|
| Placebo Comparator: Control group<br>Participants (parents of children with atopic dermatitis) receive general information about use of emollients only. | Behavioral: Control group<br>* Participants (parents of children with atopic dermatitis) in control group will receive an patient education leaflet and watch an educational video about lifestyle recommendations, and the use of emollients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the weekly amount of emollient used | Parents of patients are asked to bring the emollients to each visit at which time the emollients are weighed. | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily number of emollient usage |  | Two weeks | 
| Average daily number of topical medication (other than emollient) usage |  | Two weeks | 
| Investigator's Global Assessment (IGA) | At each visit, disease severity will be assessed using the Investigator's Global Assessment (IGA). | Two weeks | 
| Eczema Area and Severity Index (EASI) | At each visit, disease severity will be assessed using the Eczema Area and Severity Index (EASI). | Two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral Research, Emollients