EczemaNCT01143012
Group Eczema Education Visits:Impact on Patient and Family Quality of Life
A study testing Group eczema education session in people with Eczema, run by Oregon Health and Science University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 months to 6 years
- Conditions the study is for
- Eczema
- What is being tested?
- Group eczema education session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to 13 Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Subjects who have been on systemic therapies for treatment of their atopic dermatitis (prednisone or cyclosporine)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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
- Being tested
- Group eczema education session, Control group
- Keywords
- Group eczema education
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group eczema education sessionOther
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 groupOther
The control group will not attend the group eczema education session.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (3)
Assess extent of skin disease.
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.
Measured: Between 4 weeks and 4 months of the first visit.
Assess average monthly number of follow-up phone calls.
A chart review will be done to assess average monthly number of follow-up phone calls.
Measured: Between 4 weeks and 4 months of the first visit.
Assess average monthly number of urgent and emergency visits.
A chart review will be done to assess average monthly number of urgent and emergency visits.
Measured: Between 4 weeks and 4 months of the first visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2011
- Study completion13 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Tofte, Oregon Health and Science University
- Investigators
- Susan J. Tofte, FNP-C, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143012
- Sponsor's protocol ID
- Group eczema education visits
- Status last verified
- Jul 2019
- First submitted
- 9 Jun 2010
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Eczema Education Visits:Impact on Patient and Family Quality of Life
- ClinicalTrials.gov ID
- NCT01143012
- Acronym / sponsor ID
- Group eczema education visits
- Conditions
- Eczema
- Keywords
- Group eczema education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- 13 Apr 2014 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group eczema education session | Active comparator | Other: Group eczema education sessionOne group will attend a group eczema education session. All subjects will answer quality of life questions two times. |
| Control group | Active comparator | Other: Control groupThe other group will not attend the group eczema education session. Both groups will be asked quality of life questions two times. |
Who may qualify
- Ages
- 2 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects who have been on systemic therapies for treatment of their atopic dermatitis (prednisone or cyclosporine)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group eczema education sessionSubjects 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. | Other | Group eczema education session |
| Control groupThe control group will not attend the group eczema education session. | Other | Control group |
Primary outcome
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.
3 secondary outcomes
Assess extent of skin disease.
Time frame: 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.
Assess average monthly number of urgent and emergency visits.
Time frame: Between 4 weeks and 4 months of the first visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan J. Tofte, FNP-C principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group eczema education session in people with Eczema, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between the two groups in CADIS score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.