NCT02251340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

September 25, 2014

Last Update Submit

November 30, 2016

Conditions

Eczema

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

Families in the intervention group will receive an Eczema Care Plan

Behavioral: Eczema Care Plan

Control

NO INTERVENTION

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

Interventions

Eczema Care PlanBEHAVIORAL
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician, Instructor in Medicine

Study Record Dates

First Submitted

September 25, 2014

First Posted

September 29, 2014

Study Start

June 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 1, 2016

Record last verified: 2016-11

Locations

US(1)