Health Literacy for Children With Atopic Dermatitis and Their Caregivers

October 19, 2021 updated by: Gretchen K Carlisle, University of Missouri-Columbia
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri Dermatology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Physician/resident instruction
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.
Active Comparator: Nurse instruction
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.
Behavioral: Nurse instruction
The dermatology nurse will give additional verbal and written instruction utilizing "teach-back" about skin care precautions and medication usage to the caregivers/parents in the "treatment" group.
Other Names:
  • patient education
  • caregiver instruction
  • teaching
  • medication compliance instruction
  • nurse teaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Questionnaire
Time Frame: Visit 2 (or Week 4 visit)
A 27 item written questionnaire will be given to the parent/caregiver at visit 2. This questionnaire tests the retention of information given at visit 1 to subjects in both arms of the study (treatment and control group).
Visit 2 (or Week 4 visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Gretchen Carlisle, MPH, University of Missouri, Columbia, MO
  • Principal Investigator: Jonathan A Dyer, MD, University of Missouri, Columbia, MO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 4, 2010

First Submitted That Met QC Criteria

June 4, 2010

First Posted (Estimate)

June 7, 2010

Study Record Updates

Last Update Posted (Actual)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1164097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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