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

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.

Study Overview

• Status: Completed
• Conditions: Eczema
• Intervention / Treatment: Other: Group eczema education session; Other: Control group

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group eczema education session; One group will attend a group eczema education session. All subjects will answer quality of life questions two times.	Other: Group eczema education session; 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.
Active Comparator: Control group; The other group will not attend the group eczema education session. Both groups will be asked quality of life questions two times.	Other: Control group; The control group will not attend the group eczema education session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Between 4 weeks and 4 months of the first visit.
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.	Between 4 weeks and 4 months of the first visit.

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Susan J. Tofte, FNP-C, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): April 13, 2014

Study Registration Dates

• First Submitted: June 9, 2010
• First Submitted That Met QC Criteria: June 11, 2010
• First Posted (Estimate): June 14, 2010

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Group eczema education
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: Group eczema education visits