Health Literacy for Children With Atopic Dermatitis and Their Caregivers
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|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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|