EczemaNCT02916888
A Study Comparing the Quality of Life of Patients in the Treatment of Eczema by Pediatric Generalists and Specialists
An observational study of Eczema and Dermatitis, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the differences in the quality of life of patients and caregivers who are treated by general pediatricians versus pediatric dermatologists for eczema (atopic dermatitis or AD). Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Eczema, Dermatitis, Dermatitis, Atopic
- What is being tested?
- Care provided by general pediatrician and Care provided by pediatric dermatologist
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Dec 2017
- Phase
- Observational
- 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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients under 7 years old that have atopic dermatitis from the Greater New Haven area.
Who may be able to join
- Meet the clinical criteria for the diagnosis of atopic dermatitis
- Have disease over at least 5% of their total body surface area.
- Less than 7 years of age.
- Families able to comprehend written instructions in English and able to complete questionnaires with assistance if needed.
- Parents/guardians able to understand and willing to sign a parental permission form.
Who cannot join
- Clinically infected atopic dermatitis.
- Lack of follow-up after initial visit or regimen non-adherence.
- Patients who are allergic or intolerant of the topical medications employed in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Dermatology Associates
New Haven, Connecticut, 06511
About this study
Official title: Patient and Caregiver Quality of Life in the Treatment of Atopic Dermatitis in Pediatric Patients: a Comparison Between a General Pediatric Practice and a Pediatric Dermatology Practice
The purpose of this study is to investigate the differences in the quality of life of patients and caregivers who are treated by general pediatricians versus pediatric dermatologists for eczema (atopic dermatitis or AD).
Read the detailed description
Hypothesis:
We hypothesize that on average, the patients treated by the general pediatrician will have a smaller increase in quality of life at the end of the 2-week treatment period when compared to patients treated by the specialist.
Methods:
The primary endpoint will be the difference in patient and caregiver quality of life from baseline for the group treated by the general pediatrician and the group treated by the pediatric dermatologist. Secondary endpoints will be the difference in atopic dermatitis severity and TCS phobia from baseline.
Patients will be recruited from the Yale Pediatric Dermatology Clinic and Long Wharf Pediatrics and Adolescent Medicine in New Haven, CT.
Data Collection:
Assessment of AD by the investigator (EASI) and the patient/caregiver (POEM) will be completed at baseline on Day 0 in the clinic. Quality life measures (CDLQI/IDQoL/DFI) and steroid phobia measure (TOPICOP) will also be completed on Day 0. Follow-up clinical assessment will include skin examinations, and will be performed on Day 14. On the follow-up visit, the investigator will perform an assessment of AD severity using the EASI scoring method, ask patients/caregivers to re-take the CDLQI or IDQoL, DFI, POEM and TOPICOP, ask patients/caregivers to report adverse effects, and take digital photography utilizing the same standard poses as baseline. Patients' medication will be weighed to estimate amount of medication used in the 2-week treatment period. We will also instruct the patients and families to treat any subsequent AD flares in a similar manner as the first two weeks of the study, however they will treat until clear and may discontinue prior to 2 weeks of therapy.
Blinding:
This will be a single-blinded study. Patients will only know that there are 2 patient groups that are being treated by physicians, and that these 2 groups are being compared, but will not know that one group is being treated by a generalist and the other by a specialist. Given the study design, it will be impossible to blind investigators.
Treatment Administration:
There will be no research treatment/procedures that are not standard of care treatment. Standard of care treatment will be administered on an outpatient basis. All patients treated will receive a one-page handout, which briefly explains AD and educates families on how to prevent further atopic dermatitis outbreaks. All patients will also receive a page explaining how to apply corticosteroid ointment for treatment of AD.
Patients will adhere to twice daily administration of corticosteroid ointment for 2 weeks, and then will be assessed for clearance of AD. Caregivers or patients will document adherence at home daily in a chart that will be provided to them at their initial visit.
- Conditions
- Eczema, Dermatitis, Dermatitis, Atopic, Genetic Disease, Inborn, Hypersensitivity, Hypersensitivity, Immediate
- Being tested
- Care provided by general pediatrician, Care provided by pediatric dermatologist
- Keywords
- Atopic dermatitis, Topical corticosteroid, Pediatric, Eczema, Quality of life
- Medical subject headings
- Eczema, Dermatitis, Dermatitis, Atopic, Genetic Diseases, Inborn, Hypersensitivity, Hypersensitivity, Immediate, Immune System Diseases, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care provided by general pediatricianOther
Standard of care management of atopic dermatitis by a general pediatrician.
Care provided by pediatric dermatologistOther
Standard of care management of atopic dermatitis by a pediatric dermatologist.
| Study group | Role | What they receive |
|---|---|---|
| Care provided by general pediatrician | Standard of care management of atopic dermatitis by general pediatrician. This includes an initial visit with a 2-week follow-up. Receives: Other: Care provided by general pediatrician | |
| Care provided by pediatric dermatologist | Standard of care management of atopic dermatitis by pediatric dermatologist. This includes an initial visit with a 2-week follow-up. Receives: Other: Care provided by pediatric dermatologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life of patients
Measured using Infant's Dermatitis Quality of Life Index (IDQoL) or Children's Dermatology Life Quality Index(CDLQI) depending on age
Measured: 2 weeks
Secondary outcomes (3)
Change in quality of life of patient caregivers
Measured using Dermatitis Family Impact questionnaire (DFI)
Measured: 2 weeks
Change in clinical severity of atopic dermatitis
Measured using Eczema Area and Severity Index (EASI) or Patient-Oriented Eczema Measure (POEM)
Measured: 2 weeks
Change in topical corticosteroid phobia in caregivers
Measured using Topical Corticosteroid Phobia scale (TOPICOP)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EczemaStudies of the same condition, open and under way.
- More trials run by Yale 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Antaya, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916888
- Sponsor's protocol ID
- 1605017845
- Status last verified
- Jan 2018
- First submitted
- 23 Sep 2016
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Eichenfield LF, Tom WL, Chamlin SL, Feldman SR, Hanifin JM, Simpson EL, Berger TG, Bergman JN, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Krol A, Margolis DJ, Paller AS, Schwarzenberger K, Silverman RA, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014 Feb;70(2):338-51. doi: 10.1016/j.jaad.2013.10.010. Epub 2013 Nov 27.
PubMed 24290431
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Caregiver Quality of Life in the Treatment of Atopic Dermatitis in Pediatric Patients: a Comparison Between a General Pediatric Practice and a Pediatric Dermatology Practice
- ClinicalTrials.gov ID
- NCT02916888
- Acronym / sponsor ID
- 1605017845
- Conditions
- Eczema, Dermatitis, Dermatitis, Atopic, Genetic Disease, Inborn, Hypersensitivity, Hypersensitivity, Immediate
- Keywords
- Atopic dermatitis, Topical corticosteroid, Pediatric, Eczema, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 28 Sep 2016 (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 purpose of this study is to investigate the differences in the quality of life of patients and caregivers who are treated by general pediatricians versus pediatric dermatologists for eczema (atopic dermatitis or AD).
Detailed description
Hypothesis:
We hypothesize that on average, the patients treated by the general pediatrician will have a smaller increase in quality of life at the end of the 2-week treatment period when compared to patients treated by the specialist.
Methods:
The primary endpoint will be the difference in patient and caregiver quality of life from baseline for the group treated by the general pediatrician and the group treated by the pediatric dermatologist. Secondary endpoints will be the difference in atopic dermatitis severity and TCS phobia from baseline.
Patients will be recruited from the Yale Pediatric Dermatology Clinic and Long Wharf Pediatrics and Adolescent Medicine in New Haven, CT.
Data Collection:
Assessment of AD by the investigator (EASI) and the patient/caregiver (POEM) will be completed at baseline on Day 0 in the clinic. Quality life measures (CDLQI/IDQoL/DFI) and steroid phobia measure (TOPICOP) will also be completed on Day 0. Follow-up clinical assessment will include skin examinations, and will be performed on Day 14. On the follow-up visit, the investigator will perform an assessment of AD severity using the EASI scoring method, ask patients/caregivers to re-take the CDLQI or IDQoL, DFI, POEM and TOPICOP, ask patients/caregivers to report adverse effects, and take digital photography utilizing the same standard poses as baseline. Patients' medication will be weighed to estimate amount of medication used in the 2-week treatment period. We will also instruct the patients and families to treat any subsequent AD flares in a similar manner as the first two weeks of the study, however they will treat until clear and may discontinue prior to 2 weeks of therapy.
Blinding:
This will be a single-blinded study. Patients will only know that there are 2 patient groups that are being treated by physicians, and that these 2 groups are being compared, but will not know that one group is being treated by a generalist and the other by a specialist. Given the study design, it will be impossible to blind investigators.
Treatment Administration:
There will be no research treatment/procedures that are not standard of care treatment. Standard of care treatment will be administered on an outpatient basis. All patients treated will receive a one-page handout, which briefly explains AD and educates families on how to prevent further atopic dermatitis outbreaks. All patients will also receive a page explaining how to apply corticosteroid ointment for treatment of AD.
Patients will adhere to twice daily administration of corticosteroid ointment for 2 weeks, and then will be assessed for clearance of AD. Caregivers or patients will document adherence at home daily in a chart that will be provided to them at their initial visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care provided by general pediatrician | – | Other: Care provided by general pediatricianStandard of care management of atopic dermatitis by general pediatrician. This includes an initial visit with a 2-week follow-up. |
| Care provided by pediatric dermatologist | – | Other: Care provided by pediatric dermatologistStandard of care management of atopic dermatitis by pediatric dermatologist. This includes an initial visit with a 2-week follow-up. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients under 7 years old that have atopic dermatitis from the Greater New Haven area.
Key inclusion criteria (5 listed)
- Meet the clinical criteria for the diagnosis of atopic dermatitis
- Have disease over at least 5% of their total body surface area.
- Less than 7 years of age.
- Families able to comprehend written instructions in English and able to complete questionnaires with assistance if needed.
- Parents/guardians able to understand and willing to sign a parental permission form.
Key exclusion criteria (3 listed)
- Clinically infected atopic dermatitis.
- Lack of follow-up after initial visit or regimen non-adherence.
- Patients who are allergic or intolerant of the topical medications employed in this study.
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 |
|---|---|---|
| Care provided by general pediatricianStandard of care management of atopic dermatitis by a general pediatrician. | Other | Care provided by general pediatrician |
| Care provided by pediatric dermatologistStandard of care management of atopic dermatitis by a pediatric dermatologist. | Other | Care provided by pediatric dermatologist |
Primary outcome
Change in quality of life of patients
Time frame: 2 weeks
Measured using Infant's Dermatitis Quality of Life Index (IDQoL) or Children's Dermatology Life Quality Index(CDLQI) depending on age
3 secondary outcomes
Change in quality of life of patient caregivers
Time frame: 2 weeks
Change in clinical severity of atopic dermatitis
Time frame: 2 weeks
Change in topical corticosteroid phobia in caregivers
Time frame: 2 weeks
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 Jan 2018.
- Background: PubMed 24290431Eichenfield LF, Tom WL, Chamlin SL, Feldman SR, Hanifin JM, Simpson EL, Berger TG, Bergman JN, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Krol A, Margolis DJ, Paller AS, Schwarzenberger K, Silverman RA, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014 Feb;70(2):338-51. doi: 10.1016/j.jaad.2013.10.010. Epub 2013 Nov 27.
- Individual participant dataSharing planned: Undecided
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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.
Richard Antaya, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eczema and Dermatitis, run by Yale 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 5 inclusion and 3 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 Jan 2018. 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?
Change in quality of life of patients (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02916888, which also lists 1 linked publication.
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 Jan 2018.