Group Eczema Education Visits:Impact on Patient and Family Quality of Life
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Eczema |
Other: Group eczema education session Other: Control group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Group Eczema Education Visits:Impact on Patient and Family Quality of Life |
- The difference between the two groups in CADIS score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
- Assess extent of skin disease. [ Time Frame: Between 4 weeks and 4 months of the first visit. ] [ Designated as safety issue: No ]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. [ Time Frame: Between 4 weeks and 4 months of the first visit. ] [ Designated as safety issue: No ]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. [ Time Frame: Between 4 weeks and 4 months of the first visit. ] [ Designated as safety issue: No ]A chart review will be done to assess average monthly number of urgent and emergency visits.
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2010 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 2 Months to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Contact: Susan J. Tofte, FNP-C | 503 494 6445 | toftes@ohsu.edu |
| Contact: Karen E. Minzer-Conzetti, M.D. | 503 494 8211 | minzerco@ohsu.edu |
| United States, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Susan J. Tofte, FNP-C 503-494-6445 toftes@ohsu.edu | |
| Contact: Karen E. Minzer-Conzetti, M.D. 503 494 8211 minzerco@ohsu.edu | |
| Principal Investigator: Susan J. Tofte, FNP-C | |
| Sub-Investigator: Karen E. Minzer-Conzetti, M.D. | |
| Sub-Investigator: Jon M. Hanifin, M.D. | |
| Sub-Investigator: Eric L. Simpson, M.D., M.C.R. | |
| Sub-Investigator: Alfons L. Krol, M.D. | |
| Sub-Investigator: Dawn H. Siegel, M.D. | |
| Principal Investigator: | Susan J. Tofte, FNP-C | Oregon Health and Science University |
More Information
No publications provided
| Responsible Party: | Susan J. Tofte, FNP-C, Oregon Health & Science University |
| ClinicalTrials.gov Identifier: | NCT01143012 History of Changes |
| Other Study ID Numbers: | Group eczema education visits |
| Study First Received: | June 9, 2010 |
| Last Updated: | August 1, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Oregon Health and Science University:
|
Group eczema education |
Additional relevant MeSH terms:
|
Eczema Dermatitis Skin Diseases Skin Diseases, Eczematous |
ClinicalTrials.gov processed this record on May 23, 2013