Health Literacy for Children With Atopic Dermatitis and Their Caregivers
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:||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|
- 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.
- 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).
|Study Start Date:||June 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138761
|United States, Missouri|
|University of Missouri Dermatology Clinic|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Gretchen Carlisle, MPH||University of Missouri, Columbia, MO|
|Principal Investigator:||Jonathan A Dyer, MD||University of Missouri, Columbia, MO|