search
Back to results

Randomized Controlled Trial of an Eczema Care Plan

Primary Purpose

Eczema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eczema Care Plan
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eczema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Families in the intervention group will receive an Eczema Care Plan

Families in the control group will not receive an Eczema Care Plan

Outcomes

Primary Outcome Measures

proportion of patients with moderate/severe/very severe eczema
quality of life measured via validated survey
parental knowledge measured via survey

Secondary Outcome Measures

Full Information

First Posted
September 25, 2014
Last Updated
November 30, 2016
Sponsor
Boston Children's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02251340
Brief Title
Randomized Controlled Trial of an Eczema Care Plan
Official Title
Randomized Controlled Trial of an Eczema Care Plan
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Families in the intervention group will receive an Eczema Care Plan
Arm Title
Control
Arm Type
No Intervention
Arm Description
Families in the control group will not receive an Eczema Care Plan
Intervention Type
Behavioral
Intervention Name(s)
Eczema Care Plan
Primary Outcome Measure Information:
Title
proportion of patients with moderate/severe/very severe eczema
Time Frame
1 month for each patient
Title
quality of life measured via validated survey
Time Frame
1 month for each patient
Title
parental knowledge measured via survey
Time Frame
1 month for each patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Randomized Controlled Trial of an Eczema Care Plan

We'll reach out to this number within 24 hrs