Clinical trial NCT01143012: 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
Overall status: COMPLETED
Phase: NA
Conditions: Eczema
Keywords: Group eczema education
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2010-06-14
Enrollment: 36
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: The difference between the two groups in CADIS score
timeFrame: 4 weeks
Secondary outcomes:
measure: Assess extent of skin disease.
timeFrame: Between 4 weeks and 4 months of the first visit.
measure: Assess average monthly number of follow-up phone calls.
timeFrame: Between 4 weeks and 4 months of the first visit.
measure: Assess average monthly number of urgent and emergency visits.
timeFrame: Between 4 weeks and 4 months of the first visit.
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Susan J. Tofte, FNP-C
role: PRINCIPAL_INVESTIGATOR
References: