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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
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief 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).

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

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.

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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Eczema

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in quality of life of patient caregivers [ Time Frame: 2 weeks ]
    Measured using Dermatitis Family Impact questionnaire (DFI)

  2. 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)

  3. Change in topical corticosteroid phobia in caregivers [ Time Frame: 2 weeks ]
    Measured using Topical Corticosteroid Phobia scale (TOPICOP)


Biospecimen Retention:   None Retained
Saliva samples for salivary cortisol detection


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients under 7 years old that have atopic dermatitis from the Greater New Haven area.
Criteria

Inclusion Criteria:

  1. Meet the clinical criteria for the diagnosis of atopic dermatitis
  2. Have disease over at least 5% of their total body surface area.
  3. Less than 7 years of age.
  4. Families able to comprehend written instructions in English and able to complete questionnaires with assistance if needed.
  5. Parents/guardians able to understand and willing to sign a parental permission form.

Exclusion Criteria:

  1. Clinically infected atopic dermatitis.
  2. Lack of follow-up after initial visit or regimen non-adherence.
  3. Patients who are allergic or intolerant of the topical medications employed in this study.

Information from the National Library of Medicine

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


Locations
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United States, Connecticut
Yale Dermatology Associates
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Richard Antaya, MD Yale School of Medicine
Publications:
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02916888    
Other Study ID Numbers: 1605017845
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yale University:
Atopic dermatitis
Topical corticosteroid
Pediatric
Eczema
Quality of life
Additional relevant MeSH terms:
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Genetic Diseases, Inborn
Dermatitis, Atopic
Skin Diseases, Genetic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate