NCT00826592

Brief Summary

The purpose of this study is to compare the effect of video-based patient education with written instruction on subjects' knowledge of atopic dermatitis and their disease severity, measured by the Patient-oriented Eczema Measure (POEM), after viewing the educational materials.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

7 months

First QC Date

January 20, 2009

Last Update Submit

April 15, 2015

Conditions

Keywords

patient educationdermatology patient educationatopic dermatitisatopic dermatitis educationatopic eczemainfantile eczemahand eczema

Outcome Measures

Primary Outcomes (1)

  • Subjects' disease severity measured by the patient-oriented eczema measure (POEM).

    3 months

Secondary Outcomes (1)

  • Subjects'comprehension and attitude towards video-based and written education materials.

    3 months

Study Arms (2)

Video-based education arm

EXPERIMENTAL

Subjects receiving the video-based educational material

Other: Patient Educational Materials

Written education arm:

ACTIVE COMPARATOR

Subjects receiving the written educational material

Other: Patient Educational Materials

Interventions

In the experimental arm, the intervention is the video-based patient educational material on atopic dermatitis. In the active comparison arm (control arm), the comparison intervention is written patient educational material on atopic dermatitis.

Also known as: Patient educational materials on atopic dermatitis
Video-based education armWritten education arm:

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older at time of consent, may be men or women.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Capable of giving informed consent.

You may not qualify if:

  • Non-English speaking individuals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Links

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Study Officials

  • April Armstrong, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 22, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations