Randomized Controlled Trial of an Eczema Care Plan

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 Overview

• Status: Completed
• Conditions: Eczema
• Intervention / Treatment: Behavioral: Eczema Care Plan

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Families in the intervention group will receive an Eczema Care Plan	Behavioral: Eczema Care Plan
No Intervention: Control; Families in the control group will not receive an Eczema Care Plan

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimate): September 29, 2014

Study Record Updates

• Last Update Posted (Estimate): December 1, 2016
• Last Update Submitted That Met QC Criteria: November 30, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: ChildrensH