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Group Eczema Education Visits:Impact on Patient and Family Quality of Life

Primary Purpose

Eczema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group eczema education session
Control group
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eczema focused on measuring Group eczema education

Eligibility Criteria

2 Months - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children ages 2 months though 6 years.
  • Participants must carry a diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria.
  • New patients or consultations at an OHSU clinic.
  • English-speaking families will be included in this study

Exclusion Criteria:

  • Subjects who have been on systemic therapies for treatment of their atopic dermatitis (prednisone or cyclosporine)

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group eczema education session

Control group

Arm Description

One group will attend a group eczema education session. All subjects will answer quality of life questions two times.

The other group will not attend the group eczema education session. Both groups will be asked quality of life questions two times.

Outcomes

Primary Outcome Measures

The difference between the two groups in CADIS score
The primary outcome will be the difference between the two groups in CADIS score as measured at four weeks. CADIS is a validated outcome of pediatric quality of life in AD.

Secondary Outcome Measures

Assess extent of skin disease.
EASI (Eczema Area and Severity Index) scores will be performed to assess extent of skin disease at an interval between 4 weeks and 4 months of the first visit.
Assess average monthly number of follow-up phone calls.
A chart review will be done to assess average monthly number of follow-up phone calls.
Assess average monthly number of urgent and emergency visits.
A chart review will be done to assess average monthly number of urgent and emergency visits.

Full Information

First Posted
June 9, 2010
Last Updated
July 9, 2019
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT01143012
Brief Title
Group Eczema Education Visits:Impact on Patient and Family Quality of Life
Official Title
Group Eczema Education Visits:Impact on Patient and Family Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
April 13, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to determine whether group educational visits improve the quality of life of patients referred to the Dermatology Clinic. Secondary outcomes will be to determine whether group educational visits influences other key elements of patient care such as topical steroid usage, disease exacerbations, emergency visits, and phone calls to the office. Lastly, the investigators hope to evaluate which aspects of the educational visit were found to be the most helpful to families caring for children with atopic dermatitis (AD). Patients will be new atopic dermatitis referrals to OHSU dermatology and pediatric dermatology clinics. All consecutive patients with such appointments during a three month time period will be screened for participation in the study. Parents will be recruited via telephone. In the intervention group, parents will be invited to participate in a group education visit prior to their first appointment with a dermatologist. All parents in the study will fill out questionnaires. The children involved in the study will be assigned an eczema severity score during their routine visits, but this will be incorporated into the regular clinic assessment. The Childhood Atopic Dermatitis Impact Scale (CADIS) assesses the quality of life in households with children who have atopic dermatitis. The Eczema Area and Severity Index (EASI) measures the extent and severity of the patient's atopic dermatitis. The change in CADIS scores will be analyzed to determine if there is a more significant improvement in quality of life for the group in which parents receive the group eczema education visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema
Keywords
Group eczema education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group eczema education session
Arm Type
Active Comparator
Arm Description
One group will attend a group eczema education session. All subjects will answer quality of life questions two times.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The other group will not attend the group eczema education session. Both groups will be asked quality of life questions two times.
Intervention Type
Other
Intervention Name(s)
Group eczema education session
Intervention Description
Subjects in the intervention group will participate in a group education visit to discuss topics such as subjects' general understanding and knowledge of eczema and its treatment.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
The control group will not attend the group eczema education session.
Primary Outcome Measure Information:
Title
The difference between the two groups in CADIS score
Description
The primary outcome will be the difference between the two groups in CADIS score as measured at four weeks. CADIS is a validated outcome of pediatric quality of life in AD.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Assess extent of skin disease.
Description
EASI (Eczema Area and Severity Index) scores will be performed to assess extent of skin disease at an interval between 4 weeks and 4 months of the first visit.
Time Frame
Between 4 weeks and 4 months of the first visit.
Title
Assess average monthly number of follow-up phone calls.
Description
A chart review will be done to assess average monthly number of follow-up phone calls.
Time Frame
Between 4 weeks and 4 months of the first visit.
Title
Assess average monthly number of urgent and emergency visits.
Description
A chart review will be done to assess average monthly number of urgent and emergency visits.
Time Frame
Between 4 weeks and 4 months of the first visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children ages 2 months though 6 years. Participants must carry a diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria. New patients or consultations at an OHSU clinic. English-speaking families will be included in this study Exclusion Criteria: Subjects who have been on systemic therapies for treatment of their atopic dermatitis (prednisone or cyclosporine)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan J. Tofte, FNP-C
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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