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

NCT01143012 | Completed

• 1 other identifier: Group eczema education visits
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Eczema

Keywords

Group eczema education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assess extent of skin disease.

  Between 4 weeks and 4 months of the first visit.

• 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.

  Between 4 weeks and 4 months of the first visit.

Study Arms (2)

Group eczema education session

ACTIVE COMPARATOR

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

Other: Group eczema education session

Control group

ACTIVE COMPARATOR

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

Interventions

Group eczema education session OTHER

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.

Group eczema education session

Control group OTHER

The control group will not attend the group eczema education session.

Control group

Eligibility Criteria

• Age: 2 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Eczema

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Susan J. Tofte, FNP-C

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 14, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: April 13, 2014
• Last Updated: July 11, 2019

Record last verified: 2019-07

Locations

US (1)