Randomized Controlled Trial of an Eczema Care Plan

Overview

The objectives of this project are to increase families' understanding of eczema and improve eczema management in the primary care setting. We have created an "Eczema Care Plan" similar to those used in the management of asthma. It gives specific instructions about medications, bathing and moisturizing, as well as when to seek further treatment. We will conduct a randomized controlled trial of the plan in Primary Care at Longwood for a 10 month period. Specifically, we aim to (1) decrease eczema severity (2) improve patient quality of life and (3) increase parental knowledge and confidence about eczema management. We also plan to track provider uptake and documentation of the plan and elicit feedback from parents and providers on the utility and feasibility of the plan.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2016

Interventions

  • Behavioral: Eczema Care Plan

Arms, Groups and Cohorts

  • Experimental: Intervention
    • Families in the intervention group will receive an Eczema Care Plan
  • No Intervention: Control
    • Families in the control group will not receive an Eczema Care Plan

Clinical Trial Outcome Measures

Primary Measures

  • proportion of patients with moderate/severe/very severe eczema
    • Time Frame: 1 month for each patient
  • quality of life measured via validated survey
    • Time Frame: 1 month for each patient
  • parental knowledge measured via survey
    • Time Frame: 1 month for each patient

Participating in This Clinical Trial

Inclusion Criteria

a) accompanying adult speaks English b) patient has a history of eczema c) patient is between the ages of 1 month and 16 years d) family is coming for an eczema visit or plans to discuss eczema e) accompanying adult is a primary caregiver f) child is not in foster care g) caregiver has not received an eczema care plan previously. - Exclusion Criteria:

a) accompanying adult does not speak English b) patient does not have a history of eczema c) patient is younger than 1 month or older than 16 years of age d) eczema will not be discussed at the visit e) accompanying adult is not the primary caregiver f) child is in foster care g) caregiver has received an eczema care plan previously.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boston Children’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Corinna Rea, Staff Physician, Instructor in Medicine – Boston Children’s Hospital

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