Study Stopped
Enrollment was significantly under target.
Health Literacy for Children With Atopic Dermatitis and Their Caregivers
1 other identifier
interventional
33
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 4, 2010
CompletedFirst Posted
Study publicly available on registry
June 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedOctober 28, 2021
October 1, 2021
1.3 years
June 4, 2010
October 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Eczema Area and Severity Index (EASI)
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 Outcomes (1)
Caregiver Questionnaire
Visit 2 (or Week 4 visit)
Study Arms (2)
Physician/resident instruction
NO INTERVENTIONThis 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.
Nurse instruction
ACTIVE COMPARATORFollowing 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- New clinical diagnosis of pediatric atopic dermatitis, or existing atopic dermatitis but new patient to MU dermatology
- Age 7 or under
You may not qualify if:
- Age 8 or above
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Missouri Dermatology Clinic
Columbia, Missouri, 65212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gretchen Carlisle, MPH
University of Missouri, Columbia, MO
- PRINCIPAL INVESTIGATOR
Jonathan A Dyer, MD
University of Missouri, Columbia, MO
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
June 4, 2010
First Posted
June 7, 2010
Study Start
June 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
October 28, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share