A Study Comparing the Quality of Life of Patients in the Treatment of Eczema by Pediatric Generalists and Specialists

January 9, 2018 updated by: Yale University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale Dermatology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients under 7 years old that have atopic dermatitis from the Greater New Haven area.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life of patient caregivers
Time Frame: 2 weeks
Measured using Dermatitis Family Impact questionnaire (DFI)
2 weeks
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)
2 weeks
Change in topical corticosteroid phobia in caregivers
Time Frame: 2 weeks
Measured using Topical Corticosteroid Phobia scale (TOPICOP)
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 28, 2016

Study Record Updates

Last Update Posted (Actual)

January 11, 2018

Last Update Submitted That Met QC Criteria

January 9, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1605017845

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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