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

NCT ID: NCT01143012

Last Updated: 2019-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-04-13

Brief Summary

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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.

Detailed Description

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Conditions

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Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group eczema education session

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

Group Type ACTIVE_COMPARATOR

Group eczema education session

Intervention Type 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

The other group will not attend the group eczema education session. Both groups will be asked quality of life questions two times.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Control group

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

2 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Susan Tofte

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan J. Tofte, FNP-C

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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Group eczema education visits

Identifier Type: -

Identifier Source: org_study_id

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