NCT02343861

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

January 16, 2015

Last Update Submit

March 14, 2018

Conditions

Dermatitis, Atopic

Keywords

Behavioral ResearchEmollients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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)

    Two weeks

  • Eczema Area and Severity Index (EASI)

    Two weeks

Study Arms (2)

Tailored leaflet group

ACTIVE COMPARATOR

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

Control group

PLACEBO COMPARATOR

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

Behavioral: Control group

Interventions

Tailored leaflet groupBEHAVIORAL

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.

Also known as: Tailored leaflet about the adequate use of emollient
Tailored leaflet group
Control groupBEHAVIORAL

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.

Control group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A parent of 0-5 year old children with mild to moderate atopic dermatitis
  • years of age or older
  • Apply emollient for themselves to their children with atopic dermatitis

You may not qualify if:

  • Parents of children with severe atopic dermatitis or showing signs of acute infection (Oozing, vesicles, edema, redness or pain)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Seoul National University Boramae Hospital

Seoul, 156-707, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 28566920RESULT

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Hyun-Sun Yoon, MD, PhD

    Department of Dermatology, Seoul National University Boramae Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 22, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 15, 2018

Record last verified: 2018-03

Locations

KR(1)