Health Literacy for Children With Atopic Dermatitis and Their Caregivers
|ClinicalTrials.gov Identifier: NCT01138761|
Recruitment Status : Terminated (Enrollment was significantly under target.)
First Posted : June 7, 2010
Last Update Posted : June 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Behavioral: Nurse instruction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Health Literacy for Children With Atopic Dermatitis and Their Caregivers|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
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.
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|