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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01143012
First received: June 9, 2010
Last updated: August 1, 2011
Last verified: May 2010
  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

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143012

Contacts
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

Locations
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.         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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 October 29, 2014