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Health Literacy for Children With Atopic Dermatitis and Their Caregivers

This study has been terminated.
(Enrollment was significantly under target.)
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01138761
First received: June 4, 2010
Last updated: January 3, 2013
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Health Literacy
Atopic Dermatitis
 Behavioral: Nurse instruction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Health Literacy for Children With Atopic Dermatitis and Their Caregivers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Caregiver Questionnaire [ Time Frame: Visit 2 (or Week 4 visit) ] [ Designated as safety issue: No ]
    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).


Enrollment: 33
Study Start Date: June 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138761

Locations
United States, Missouri
University of Missouri Dermatology Clinic
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Jonathan A Dyer, MD, University of Missouri
ClinicalTrials.gov Identifier: NCT01138761     History of Changes
Other Study ID Numbers: 1164097
Study First Received: June 4, 2010
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
pediatric atopic dermatitis
EASI
REALM-SF
nurse instruction
health literacy

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
 Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013