A Study Comparing the Quality of Life of Patients in the Treatment of Eczema by Pediatric Generalists and Specialists
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|ClinicalTrials.gov Identifier: NCT02916888|
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : January 11, 2018
|Condition or disease||Intervention/treatment|
|Eczema Dermatitis Dermatitis, Atopic Genetic Disease, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic||Other: Care provided by general pediatrician Other: Care provided by pediatric dermatologist|
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.
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.
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.
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.
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 Type :||Observational|
|Actual Enrollment :||26 participants|
|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|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
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.
Other: Care provided by general pediatrician
Standard of care management of atopic dermatitis by a 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.
Other: Care provided by pediatric dermatologist
Standard of care management of atopic dermatitis by a pediatric dermatologist.
- 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
- Change in quality of life of patient caregivers [ Time Frame: 2 weeks ]Measured using Dermatitis Family Impact questionnaire (DFI)
- Change in clinical severity of atopic dermatitis [ Time Frame: 2 weeks ]Measured using Eczema Area and Severity Index (EASI) or Patient-Oriented Eczema Measure (POEM)
- Change in topical corticosteroid phobia in caregivers [ Time Frame: 2 weeks ]Measured using Topical Corticosteroid Phobia scale (TOPICOP)
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916888
|United States, Connecticut|
|Yale Dermatology Associates|
|New Haven, Connecticut, United States, 06511|
|Principal Investigator:||Richard Antaya, MD||Yale School of Medicine|