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Completed

NCT Number: NCT01143012

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.

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Key information

Age range

2 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Control Group

Other

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

Primary outcomes

  1. The difference between the two groups in CADIS score

    Time frame: 4 weeks

    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 outcomes

  1. Assess extent of skin disease.

    Time frame: Between 4 weeks and 4 months of the first visit.

    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.

  2. Assess average monthly number of follow-up phone calls.

    Time frame: Between 4 weeks and 4 months of the first visit.

    A chart review will be done to assess average monthly number of follow-up phone calls.

  3. Assess average monthly number of urgent and emergency visits.

    Time frame: Between 4 weeks and 4 months of the first visit.

    A chart review will be done to assess average monthly number of urgent and emergency visits.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2014
First posted
Jun 14, 2010
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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