Back to resultsHealth Literacy for Children With Atopic Dermatitis and Their Caregivers
Primary Purpose
Atopic Dermatitis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nurse instruction
Sponsored by
About this trial
This is an interventional health services research trial for Atopic Dermatitis focused on measuring pediatric atopic dermatitis, EASI, REALM-SF, nurse instruction, health literacy
Eligibility 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
Sites / Locations
- University of Missouri Dermatology Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Physician/resident instruction
Nurse instruction
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Caregiver Questionnaire
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).
Full Information
NCT ID
NCT01138761
First Posted
June 4, 2010
Last Updated
October 19, 2021
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01138761
Brief Title
Health Literacy for Children With Atopic Dermatitis and Their Caregivers
Official Title
Health Literacy for Children With Atopic Dermatitis and Their Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Enrollment was significantly under target.
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
pediatric atopic dermatitis, EASI, REALM-SF, nurse instruction, health literacy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physician/resident instruction
Arm Type
No Intervention
Arm Description
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.
Arm Title
Nurse instruction
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nurse instruction
Other Intervention Name(s)
patient education, caregiver instruction, teaching, medication compliance instruction, nurse teaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eczema Area and Severity Index (EASI)
Description
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.
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).
Secondary Outcome Measure Information:
Title
Caregiver Questionnaire
Description
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).
Time Frame
Visit 2 (or Week 4 visit)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen Carlisle, MPH
Organizational Affiliation
University of Missouri, Columbia, MO
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan A Dyer, MD
Organizational Affiliation
University of Missouri, Columbia, MO
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Dermatology Clinic
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Health Literacy for Children With Atopic Dermatitis and Their Caregivers
We'll reach out to this number within 24 hrs