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

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tailored leaflet group
Control group
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Behavioral Research, Emollients

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Department of Dermatology, Seoul National University Boramae Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tailored leaflet group

Control group

Arm Description

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.

Participants (parents of children with atopic dermatitis) receive general information about use of emollients only.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 16, 2015
Last Updated
March 14, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02343861
Brief Title
The Effectiveness of Tailored Messages on the Usage of Emollient in Patients With Atopic Dermatitis
Official Title
The Effectiveness of Tailored Messages on the Usage of Emollient in Patients With Atopic Dermatitis: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Behavioral Research, Emollients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tailored leaflet group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Participants (parents of children with atopic dermatitis) receive general information about use of emollients only.
Intervention Type
Behavioral
Intervention Name(s)
Tailored leaflet group
Other Intervention Name(s)
Tailored leaflet about the adequate use of emollient
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of the weekly amount of emollient used
Description
Parents of patients are asked to bring the emollients to each visit at which time the emollients are weighed.
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Average daily number of emollient usage
Time Frame
Two weeks
Title
Average daily number of topical medication (other than emollient) usage
Time Frame
Two weeks
Title
Investigator's Global Assessment (IGA)
Description
At each visit, disease severity will be assessed using the Investigator's Global Assessment (IGA).
Time Frame
Two weeks
Title
Eczema Area and Severity Index (EASI)
Description
At each visit, disease severity will be assessed using the Eczema Area and Severity Index (EASI).
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun-Sun Yoon, MD, PhD
Organizational Affiliation
Department of Dermatology, Seoul National University Boramae Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Dermatology, Seoul National University Boramae Hospital
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28566920
Citation
Park GY, Park HS, Cho S, Yoon HS. The Effectiveness of Tailored Education on the Usage of Moisturizers in Atopic Dermatitis: A Pilot Study. Ann Dermatol. 2017 Jun;29(3):360-362. doi: 10.5021/ad.2017.29.3.360. Epub 2017 May 11. No abstract available.
Results Reference
result

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

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