Randomized Controlled Trial of an Eczema Care Plan

Eczema Clinical Trial

Official title:

Randomized Controlled Trial of an Eczema Care Plan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251340
• Other study ID #: ChildrensH
• Status: Completed
• Phase: N/A
• First received: September 25, 2014
• Last updated: November 30, 2016
• Start date: June 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: 'Institutional Review Board'
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eczema

Intervention

Behavioral:
• Eczema Care Plan

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients with moderate/severe/very severe eczema		1 month for each patient	No
Primary	quality of life measured via validated survey		1 month for each patient	No
Primary	parental knowledge measured via survey		1 month for each patient	No