Skip to main content
Clinical Trials/NCT01138761
NCT01138761TerminatedNot Applicable

Health Literacy for Children With Atopic Dermatitis and Their Caregivers

University of Missouri-Columbia1 site in 1 country33 target enrollmentStarted: June 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
33
Locations
1
Primary Endpoint
Eczema Area and Severity Index (EASI)

Study Overview

Brief Summary

The purpose of this study is to determine the effectiveness of additional nursing instruction for the caregivers of newly diagnosed pediatric atopic dermatitis patients at the University of Missouri Dermatology clinic.

Detailed Description

The purpose of this study is to determine the effectiveness of additional nursing instruction for the caregivers of newly diagnosed pediatric atopic dermatitis patients at the University of Missouri Dermatology clinic. Caregivers of children with atopic dermatitis will be randomized to one of two instruction/education procedures. The goal is to determine if improved retention of information by caregivers/parents of children with atopic dermatitis is associated with better patient outcomes.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
— to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •New clinical diagnosis of pediatric atopic dermatitis, or existing atopic dermatitis but new patient to MU dermatology
  • •Age 7 or under

Exclusion Criteria

  • •Age 8 or above

Arms & Interventions

Physician/resident instruction

No Intervention

This arm is standard of care instruction given to parents/caregivers of children with atopic dermatitis by the dermatologist and/or dermatology resident during a patient visit.

Nurse instruction

Active Comparator

Following the usual standard of care instruction by physician/resident (which both the treatment group and the non-treatment group will receive); the dermatology nurse will give enhanced instruction about skin care and medications to the caregivers/parents who were randomized to the treatment group.

Intervention: Nurse instruction (Behavioral)

Outcomes

Primary Outcomes

Eczema Area and Severity Index (EASI)

Time Frame: EASI administered by blinded investigator at the initial visit, prior to teaching intervention; EASI again administered by same blinded investigator at visit 2 (at 4 weeks).

The Eczema Area and Severity Index is used to document extent and severity of atopic dermatitis on child's skin at the beginning of the study and again at the follow-up visit. The purpose is to determine improvement or lack of improvement following teaching intervention by nurses in the dermatology clinic.

Secondary Outcomes

  • Caregiver Questionnaire(Visit 2 (or Week 4 visit))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gretchen K Carlisle

Research Scientist

University of Missouri-Columbia

Study Sites (1)

Loading locations...

Similar Trials