Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Columbia, Missouri 65212


Purpose:

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.


Study 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. 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.


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


Study is Available At:


Original ID:

1164097


NCT ID:

NCT01138761


Secondary ID:


Study Acronym:


Brief Title:

Health Literacy for Children With Atopic Dermatitis and Their Caregivers


Official Title:

Health Literacy for Children With Atopic Dermatitis and Their Caregivers


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

7 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Missouri-Columbia


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Enrollment was significantly under target.


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

33


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gretchen Carlisle, MPH
Principal Investigator
University of Missouri, Columbia, MO

Study Dates

Start Date:June 2010
Completion Date:October 2011
Completion Type:Actual
Primary Completion Date:October 2011
Primary Completion Type:Actual
Verification Date:June 2017
Last Changed Date:June 17, 2017
First Received Date:June 4, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Eczema Area and Severity Index (EASI)
Time Frame:EASI administered by blinded investigator at the initial visit, prior to teaching intervention; EASI
Safety Issues:False
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 teachi
Outcome Type:Secondary Outcome
Measure:Caregiver Questionnaire
Time Frame:Visit 2 (or Week 4 visit)
Safety Issues:False
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).

Study Interventions

Intervention Type:Behavioral
Name:Nurse instruction
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.
Arm Name:Nurse instruction
Other Name:patient education

Study Arms

Study Arm Type:Active Comparator
Arm Name:Nurse instruction
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.
Study Arm Type:No Intervention
Arm Name:Physician/resident instruction
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Missouri-Columbia

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.